To determine the safety and efficacy of the Omnilink Elite™ Peripheral Balloon-Expandable Stent System in subjects with atherosclerotic de novo or restenotic lesions in the native common iliac artery and/or native external iliac artery.
The MOBILITY study was a prospective, non-randomized, two-arm, multi-center study. The 2 arms (Omnilink Elite arm and Absolute Pro arm) were designed to independently assess the safety and effectiveness of the 2 devices used in this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
153
Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Abbott Vascular
Santa Clara, California, United States
Major Adverse Event (MAE)
Defined as death, myocardial infarction (MI), clinically-driven target lesion revascularization, and limb loss (major amputation only) on the treated side(s).
Time frame: 9 months
Device Success
On a per device basis, the achievement of successful delivery and deployment of the trial device(s) at the intended location(s) and successful withdrawal of the delivery catheter(s).
Time frame: Acute: from beginning of index procedure to end of procedure
Technical Success
Technical success is defined as device success (the achievement of successful delivery and deployment of the trial device(s) at the intended target lesion(s), successful withdrawal of the delivery catheter(s)), and attainment of a final residual stenosis of \< 30% by QA or as reported by the investigator.
Time frame: Acute: from beginning of index procedure to end of procedure
Procedure Success
Procedure success is defined as technical success (device success and attainment of a final residual stenosis of \< 30% by QA) without complications within two (2) days after the index procedure or at hospital discharge, whichever is sooner.
Time frame: Beginning of index procedure to 2 days post-index procedure or discharge, whichever is sooner
Thigh Brachial Index (TBI) for the Treated Limb(s)
The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.
Time frame: Pre-procedure
Thigh Brachial Index (TBI) for the Treated Limb(s)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.
Time frame: Post-Procedure
Thigh Brachial Index (TBI) for the Treated Limb(s)
The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.
Time frame: 1 month
Thigh Brachial Index (TBI) for the Treated Limb(s)
The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.
Time frame: 9 months
Thigh Brachial Index (TBI) for the Treated Limb(s)
The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.
Time frame: 2 years
Thigh Brachial Index (TBI) for the Treated Limb(s)
The thigh brachial index is the ratio of the resting ipsilateral thigh systolic blood pressure as compared to the highest resting brachial systolic blood pressure. A normal range is 0.9 to 1.3.
Time frame: 3 years
Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)
The changes in thigh brachial index is the absolute change between the pre-procedure measure and the stated timepoint measure.
Time frame: Between baseline and Post-procedure
Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)
The changes in thigh brachial index is the absolute change between the pre-procedure measure and the stated timepoint measure.
Time frame: Between Baseline and 1 month
Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)
The changes in thigh brachial index is the absolute change between the pre-procedure measure and the stated timepoint measure.
Time frame: Between baseline and 9 months
Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)
The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.
Time frame: Between baseline and 2 years
Changes in Thigh Brachial Index (TBI) for the Treated Limb(s)
The changes in thigh brachial index is the ratio of change between the pre-procedure measure and the stated timepoint measure.
Time frame: Between baseline and 3 years
Walking Impairment Questionaire Scores
Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.
Time frame: Pre-procedure
Walking Impairment Questionaire Scores
Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.
Time frame: 1 month
Walking Impairment Questionaire Scores
Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.
Time frame: 9 months
Walking Impairment Questionaire Scores
Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.
Time frame: 2 years
Walking Impairment Questionaire Scores
Measured by the Walking Impairment Questionnaire (WIQ), a disease-specific instrument utilized to characterize walking ability through a questionnaire as an alternative to treadmill testing. It is a measure of subject-perceived walking performance for subjects with Peripheral Artery Disease (PAD) and/or intermittent claudication. The WIQ quantifies patient-reported walking speed, walking distance, and stair-climbing ability, respectively, on a scale of 0 (= worst) to 100 (= best). The highest possible score for each domain is 100%, which indicates no difficulty. Lowest possible score for each domain is 0%, which indicates inability to perform the activity.
Time frame: 3 years
Rutherford Becker Clinical Category for the Treated Limb(s)
The Rutherford Becker clinical category is a scale to measure chronic limb ischemia. Category and Clinical Description: 0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable
Time frame: Pre-Procedure
Rutherford Becker Clinical Category for the Treated Limb(s)
The Rutherford Becker clinical category is a scale to measure chronic limb ischemia. Category and Clinical Description: 0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable
Time frame: 1 month
Rutherford Becker Clinical Category for the Treated Limb(s)
The Rutherford Becker clinical category is a scale to measure chronic limb ischemia. Category and Clinical Description: 0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable
Time frame: 9 months
Rutherford Becker Clinical Category for the Treated Limb(s)
The Rutherford Becker clinical category is a scale to measure chronic limb ischemia. Category and Clinical Description: 0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable
Time frame: 2 years
Rutherford Becker Clinical Category for the Treated Limb(s)
The Rutherford Becker clinical category is a scale to measure chronic limb ischemia. Category and Clinical Description: 0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable
Time frame: 3 years
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)
Change in Rutherford Becker Clinical Category: Worsening Rutherford Becker Clinical Category: Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6. Improved Rutherford Becker Clinical Category: An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement.
Time frame: Between baseline and 1 month
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)
Change in Rutherford Becker Clinical Category: Worsening Rutherford Becker Clinical Category: Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6. Improved Rutherford Becker Clinical Category: An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement.
Time frame: Between baseline and 9 months
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)
Change in Rutherford Becker Clinical Category: Worsening Rutherford Becker Clinical Category: Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6. Improved Rutherford Becker Clinical Category: An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement.
Time frame: Baseline and 2 years
Changes From Baseline in Rutherford Becker Clinical Category for the Treated Limb(s)
Change in Rutherford Becker Clinical Category: Worsening Rutherford Becker Clinical Category: Deterioration (an increase) in the Rutherford Becker Clinical Category by at least two categories from baseline and subsequently from the earliest post-procedural measurement or to a category 5 or 6. Improved Rutherford Becker Clinical Category: An improvement (a decrease) in the Rutherford Becker Clinical Category of at least one category from baseline and subsequently from the earliest post-procedural measurement.
Time frame: Baseline and 3 years
Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)
Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years.Target lesion revascularization (TLR) is defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by Duplex ultrasonography (DUS) or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).
Time frame: 1 month and 9 months
Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target lesion revascularization (TLR) is defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).
Time frame: 18 months
Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target lesion revascularization (TLR) is defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).
Time frame: 2 years
Kaplan-Meier Estimate of Freedom From Target Lesion Revascularization (TLR)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target lesion revascularization (TLR) is defined as any revascularization at the target lesion with or without evidence of target lesion diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion).
Time frame: 3 years
Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)
Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a percutaneous transluminal angioplasty (PTA) balloon or stent into a study stent, that has \<50% stenosis, while treating a non-target lesion in the target vessel).
Time frame: 1 month and 9 months
Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven TLR is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a PTA balloon or stent into a study stent, that has \<50% stenosis, while treating a non-target lesion in the target vessel).
Time frame: 18 months
Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven TLR is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a PTA balloon or stent into a study stent, that has \<50% stenosis, while treating a non-target lesion in the target vessel).
Time frame: 2 years
Kaplan-Meier Estimate of Freedom From Clinically-driven Target Lesion Revascularization (CD-TLR)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven TLR is defined as: Revascularization of the stent with evidence of new distal ischemic signs (worsening Rutherford Becker Clinical Category that is clearly referable to the target lesion, and target lesion diameter stenosis ≥ 50% determined by duplex ultrasound or arteriography.) (Note: This does not include coincidental overlap of a PTA balloon or stent into a study stent, that has \<50% stenosis, while treating a non-target lesion in the target vessel).
Time frame: 3 years
Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) is defined as any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel).
Time frame: 1 month and 9 months
Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) is defined as any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel).
Time frame: 18 months
Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) is defined as any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel).
Time frame: 2 years
Kaplan-Meier Estimate of Freedom From Target Vessel Revascularization (TVR) for the Treated Limb(s)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target Vessel Revascularization (TVR) is defined as any revascularization of the target vessel, outside of the target lesion, with or without evidence of diameter stenosis ≥ 50% determined by DUS or arteriography, with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category that is clearly referable to the target vessel).
Time frame: 3 years
Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (CD-TVR) for the Treated Limb(s)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven Target Vessel Revascularization is defined as revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).
Time frame: 1 month and 9 months
Kaplan-Meier Estimate of Freedom From Clinically-driven Target Vessel Revascularization (TVR) for the Treated Limb(s)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven Target Vessel Revascularization is defined as revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography)
Time frame: 18 months
Kaplan-Meier Estimate of Freedom From Clinically Driven Target Vessel Revascularization (TVR) for the Treated Limb(s)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven Target Vessel Revascularization is defined as revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).
Time frame: 2 years
Kaplan-Meier Estimate of Freedom From Clinically DrivenTarget Vessel Revascularization (TVR) for the Treated Limb(s)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Clinically-driven Target Vessel Revascularization is defined as revascularization of the target vessel (outside the target lesion) with evidence of new distal ischemic signs (worsening Rutherford Becker clinical category that is clearly referable to the target vessel, and diameter stenosis ≥ 50% determined by DUS or arteriography).
Time frame: 3 years
Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target extremity revascularization (TER) is defined as any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).
Time frame: 1 month and 9 months
Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target extremity revascularization (TER) is defined as any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).
Time frame: 18 months
Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target extremity revascularization (TER) is defined as any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).
Time frame: 2 years
Kaplan-Meier Estimate of Freedom From Target Extremity Revascularization (TER) for the Treated Limb(s)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Target extremity revascularization (TER) is defined as any revascularization of a target extremity vessel (distal to the superior border of the inguinal ligament on the ipsilateral side) with or without evidence of vessel diameter stenosis ≥ 50% determined by DUS or arteriography, and with or without new distal ischemic sign (worsening Rutherford Becker Clinical Category).
Time frame: 3 years
Primary Stent Patency
Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure.
Time frame: 1 month
Primary Stent Patency
Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure.
Time frame: 9 months
Primary Stent Patency
Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure
Time frame: 2 years
Primary Stent Patency
Absence of in-stent restenosis of the target lesion (≥50%) as determined by duplex ultrasound or angiogram and without interval reintervention since the initial study procedure
Time frame: 3 years
Restenosis
Defined as ≥ 50% stenosis at follow-up.
Time frame: 9 months
Restenosis
Defined as ≥ 50% stenosis at follow-up.
Time frame: 2 years
Restenosis
Defined as ≥ 50% stenosis at follow-up.
Time frame: 3 years
Kaplan-Meier Estimate of Freedom From Death (All Cause)
Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years
Time frame: 1 month and 9 months
Kaplan-Meier Estimate of Freedom From Death (All Cause)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years.
Time frame: 18 months
Kaplan-Meier Estimate of Freedom From Death (All Cause)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years.
Time frame: 2 years
Kaplan-Meier Estimate of Freedom From Death (All Cause)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years.
Time frame: 3 years
Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.
Time frame: 1 month and 9 months
Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.
Time frame: 18 months
Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.
Time frame: 2 years
Kaplan-Meier Estimate of Freedom From Myocardial Infarction (MI)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The term myocardial infarction should be used when there is evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.
Time frame: 3 years
Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)
Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A major amputation will be defined as at or above the ankle.
Time frame: 1 month and 9 months
Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A major amputation will be defined as at or above the ankle.
Time frame: 18 months
Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A major amputation will be defined as at or above the ankle.
Time frame: 2 years
Kaplan-Meier Estimate of Freedom From Amputations (Major) of the Treated Limb(s)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A major amputation will be defined as at or above the ankle.
Time frame: 3 years
Kaplan-Meier Estimate of Freedom From Embolic Events
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.
Time frame: 1 month and 9 months
Kaplan-Meier Estimate of Freedom From Embolic Events
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.
Time frame: 18 months
Kaplan-Meier Estimate of Freedom From Embolic Events
Outcome measure analyzed at 1 and 9 months and at 2 and 3 years. Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.
Time frame: 2 years
Kaplan-Meier Estimate of Freedom From Embolic Events
Outcome measure analyzed at 1 and 9 months and at 2 and 3 years. Embolism is the formation of a thrombus within the target lesion or stent with migration or atherosclerotic emboli migration to a distal artery.
Time frame: 3 years
Kaplan-Meier Estimate of Freedom From Amputations (Minor) of the Treated Limb(s)
Outcome measure analysed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle.
Time frame: 1 month and 9 months
Kaplan-Meier Estimate of Freedom From Amputations (Minor) of the Treated Limb(s)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle.
Time frame: 18 months
Kaplan-Meier Estimate of Freedom From Amputations (Minor) of the Treated Limb(s)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle.
Time frame: 2 years
Kaplan-Meier Estimate of Freedom From Amputations (Minor) of the Treated Limb(s)
Outcome measure analyzed at 1, 9 and 18 months, 2 and 3 years. The removal of a body extremity by surgery. For this study, the definition of amputation will only include amputations of the limb(s) that was/were treated. A minor amputation will be defined as below the ankle.
Time frame: 3 years
Stent Thrombosis
Defined as a total occlusion documented by duplex ultrasound and/or arteriography at the stent site with or without symptoms that occurs ≤ 30 days post index procedure.
Time frame: 1 month
Changes in Quality of Life Measures: Physical Component Summary
This measure indicates the absolute change between two timepoints represented by the mean. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Time frame: Baseline and 1 month
Changes in Quality of Life Measures: Physical Component Summary
This measure indicates the absolute change between two timepoints represented by the mean. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Time frame: Baseline and 9 months
Changes in Quality of Life Measures: Physical Component Summary
This measure indicates the absolute change between two timepoints represented by the mean. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Time frame: Baseline and 2 years
Changes in Quality of Life Measures: Physical Component Summary
This measure indicates the absolute change between two timepoints represented by the mean. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Time frame: Baseline and 3 years
Changes in Quality of Life Measures: Mental Component Summary
This measure indicates the absolute change between two timepoints represented by the mean. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Time frame: Baseline and 1 month
Changes in Quality of Life Measures: Mental Component Summary
This measure indicates the absolute change between two timepoints represented by the mean. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Time frame: Baseline and 9 months
Changes in Quality of Life Measures: Mental Component Summary
This measure indicates the absolute change between two timepoints represented by the mean. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Time frame: Baseline and 2 years
Changes in Quality of Life Measures: Mental Component Summary
This measure indicates the absolute change between two timepoints represented by the mean. SF-12® Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible.
Time frame: Baseline and 3 years