The purpose of this study is to collect safety and efficacy data on the IN.PACT Admiral™ Drug Eluting Balloon (DEB) in treatment of atherosclerotic disease in the superficial femoral and/or popliteal arteries in a "real world" patient population.
Peripheral artery disease (PAD) commonly results from progressive narrowing of the arteries in the lower extremities, usually due to atherosclerosis. Progression of PAD can result in critical limb ischemia (CLI), manifested by ischemic pain at rest or in the breakdown of the skin, resulting in ulcers or gangrene which ultimately may lead to amputation and death. The IN.PACT Global Clinical Study aims to expand and understand the safety and efficacy data on the IN.PACT Admiral™ DEB in a real world population of subjects with intermittent claudication and/or rest pain (Rutherford class 2-3-4) due to obstructive disease of the superficial femoral and/or popliteal arteries.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1,535
IN.PACT Admiral™ percutaneous transluminal angioplasty (PTA) paclitaxel drug eluting balloon.
Clinical Cohort ITT - Primary Effectiveness Endpoint
Freedom from clinically-driven target lesion revascularization (TLR) within 12 months post-index procedure, which is defined as: • Any re-intervention within the target lesion(s) due to symptoms or drop of ABI ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Time frame: 12 months
Clinical Cohort ITT - Primary Safety Endpoint
A composite of freedom from device- and procedure-related mortality through 30 days, freedom from major target limb amputation and TLR within 12 months post-index procedure.
Time frame: 12 months
Imaging Cohort ITT - Primary Effectiveness Endpoint
Primary Patency within 12 months post-index procedure, which is defined as: * Freedom from clinically-driven TLR and * Freedom from restenosis as determined by DUS Peak Systolic Velocity Ratio (PSVR) ≤ 2.4. * Restenosis determined by either PSVR \>2.4 as assessed by an independent DUS core lab or \>50% stenosis as assessed by an independent angiographic core lab.
Time frame: 12 months
150mm DEB ITT Cohort - Primary Effectiveness Endpoint
Freedom from clinically-driven target lesion revascularization (TLR) within 12 months post-index procedure, which is defined as: • Any re-intervention within the target lesion(s) due to symptoms or drop of ABI ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Time frame: 12 months
Clinical Cohort ITT - MAEs
MAE (Major Adverse Events) is defined as all-cause mortality, clinically-driven TVR (Target Vessel Revascularization), major target limb amputation, thrombosis at the target lesion site.
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Fundación Favaloro
Buenos Aires, Argentina
Clinica La Sagrada Familia
Bueos Aires, Argentina
Royal Prince Alfred Hospital
Sydney, Australia
Medizinische Universität Graz
Graz, Austria
Landesklinikum Thermenregion Mödling
Mödling, Austria
Onze-Lieve-Vrouwziekenuis
Aalst, Belgium
Imelda Ziekenhuis
Bonheiden, Belgium
AZ St. Blasius
Dendermonde, Belgium
Universitair Ziekenhuis Antwerpen
Edegem, Belgium
Ziekenhuis Oost Limburg - Campus St.-Jan
Genk, Belgium
...and 55 more locations
Clinical Cohort ITT - TLR
Any Target lesion revascularisation
Time frame: 12 months
Clinical Cohort ITT - TVR
Any Target vessel revascularisation
Time frame: 12 months.
Clinical Cohort ITT - Device Success
Device success is defined as successful delivery, balloon inflation and deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP)
Time frame: Index-procedure
Clinical Cohort ITT - Clinical Success
Clinical success is defined as procedural success without procedural complications (mortality, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge
Time frame: prior to discharge
Clinical Cohort ITT - MAEs
MAE (Major Adverse Events) is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site.
Time frame: 60 months
Clinical Cohort ITT - Clinically-driven TLR
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Time frame: 60 months
Clinical Cohort ITT - TVR
Time frame: 60 months
Clinical Cohort ITT - TLR
Time frame: 60 months
Clinical Cohort ITT - Time to First Clinically-driven TLR (Days)
Time frame: 60 months
Clinical Cohort ITT - MAEs
Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 30 days.
Time frame: 30 days
Clinical Cohort ITT - MAEs
MAE is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site
Time frame: 6 Months
Clinical Cohort ITT - MAEs
MAE is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site.
Time frame: 24 Months
Clinical Cohort ITT - MAEs
MAE is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site.
Time frame: 36 Months
Clinical Cohort ITT - MAEs
MAE is defined as all-cause mortality, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site.
Time frame: 48 Months
Clinical Cohort ITT - Clinically-driven TLR
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Time frame: 30 days
Clinical Cohort ITT - Clinically-driven TLR
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Time frame: 6 Months
Clinical Cohort ITT - Clinically-driven TLR
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Time frame: 24 Months
Clinical Cohort ITT - Clinically-driven TLR
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Time frame: 36 Months
Clinical Cohort ITT - Clinically-driven TLR
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Time frame: 48 Months
Clinical Cohort ITT - TLR
Any Target lesion revascularisation
Time frame: 6 Months
Clinical Cohort ITT - TLR
Any Target lesion revascularisation
Time frame: 24 Months
Clinical Cohort ITT - TLR
Any Target lesion revascularisation
Time frame: 36 Months
Clinical Cohort ITT - TLR
Any Target lesion revascularisation
Time frame: 48 Months
Clinical Cohort ITT - TVR
Any Target lesion revascularisation
Time frame: 24 Months
Clinical Cohort ITT - TVR
Any Target lesion revascularisation
Time frame: 36 Months
Clinical Cohort ITT - TVR
Any Target lesion revascularisation
Time frame: 48 Months
Clinical Cohort ITT - TVR
Any Target lesion revascularisation
Time frame: 6 Months
Clinical Cohort ITT - Time to All-cause Mortality Through 60 Months Post-index Procedure.
All-cause mortality is reported by using the survival estimate of all cause mortality through 60 months
Time frame: 60 months
Clinical Cohort ITT - Primary Sustained Clinical Improvement
Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects
Time frame: 6 Months
Clinical Cohort ITT - Primary Sustained Clinical Improvement
Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects
Time frame: 12 Months
Clinical Cohort ITT - Primary Sustained Clinical Improvement
Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects
Time frame: 24 Months
Clinical Cohort ITT - Primary Sustained Clinical Improvement
Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects
Time frame: 36 Months
Clinical Cohort ITT - Secondary Sustained Clinical Improvement
Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time frame: 6 Months
Clinical Cohort ITT - Secondary Sustained Clinical Improvement
Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time frame: 12 Months
Clinical Cohort ITT - Secondary Sustained Clinical Improvement
Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time frame: 24 Months
Clinical Cohort ITT - Secondary Sustained Clinical Improvement
Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time frame: 36 Months
Clinical Cohort ITT - Immediate Hemodynamic Improvement at Post-index Procedure
Immediate hemodynamic improvement is defined as an ABI improvement of ≥ 0.1 or to an ABI ≥ 0.9
Time frame: Post procedure
Clinical Cohort ITT - Sustained Hemodynamic Improvement
Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time frame: 6 Months
Clinical Cohort ITT - Sustained Hemodynamic Improvement
Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time frame: 12 Months
Clinical Cohort ITT - Sustained Hemodynamic Improvement
Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time frame: 24 Months
Clinical Cohort ITT - Sustained Hemodynamic Improvement
Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time frame: 36 Months
Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
Time frame: 6 Months
Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
Time frame: 12 Months
Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
Time frame: 24 Months
Clinical Cohort ITT - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
Time frame: 36 Months
Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index)
The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.
Time frame: 6 Months
Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index)
The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.
Time frame: 12 Months
Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index)
The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.
Time frame: 24 Months
Clinical Cohort ITT - Health Related Quality of Life Scores (EQ5D Index)
The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.
Time frame: 36 Months
Clinical Cohort ITT - Procedural Success
Procedural Success is defined as residual stenosis of ≤ 50% (non-stented subjects) or ≤ 30% (stented subjects) by visual estimate
Time frame: at procedure
Imaging Cohort ITT - Duplex-defined Binary Restenosis (PSVR > 2.0) of the Target Lesion
Time frame: at 12 months, or at the time of re-intervention
Imaging Cohort ITT - Duplex-defined Binary Restenosis (PSVR > 3.4) of the Target Lesion
Time frame: At 12 months, or at the time of re-intervention
150mm DEB ITT Cohort - MAEs
Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 30 days.
Time frame: 30 days
150mm DEB ITT Cohort - MAEs
Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 6 months.
Time frame: 6 months
150mm DEB ITT Cohort - MAEs
Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 12 months.
Time frame: 12 months
150mm DEB ITT Cohort - MAEs
Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 24 months.
Time frame: 24 months
150mm DEB ITT Cohort - MAEs
Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 36 months.
Time frame: 36 months
150mm DEB ITT Cohort - MAEs
Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 48 months.
Time frame: 48 months
150mm DEB ITT Cohort - MAEs
Major Adverse Events (MAE) defined as all-cause death, clinically-driven TVR, major target limb amputation, thrombosis at the target lesion site at 60 months.
Time frame: 60 months
150mm DEB ITT Cohort - Clinically-driven TLR
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Time frame: 30 days
150mm DEB ITT Cohort - Clinically-driven TLR
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Time frame: 6 months
150mm DEB ITT Cohort - Clinically-driven TLR
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Time frame: 24 months
150mm DEB ITT Cohort - Clinically-driven TLR
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Time frame: 36 months
150mm DEB ITT Cohort - Clinically-driven TLR
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Time frame: 48 months
150mm DEB ITT Cohort - Clinically-driven TLR
Clinically-driven TLR is defined as any re-intervention at the target lesion due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Time frame: 60 months
150mm DEB ITT Cohort - TLR
Any Target lesion revascularisation
Time frame: 6 Months
150mm DEB ITT Cohort - TLR
Any Target lesion revascularisation
Time frame: 12 Months
150mm DEB ITT Cohort - TLR
Any Target lesion revascularisation
Time frame: 24 Months
150mm DEB ITT Cohort - TLR
Any Target lesion revascularisation
Time frame: 36 Months
150mm DEB ITT Cohort - TLR
Any Target lesion revascularisation
Time frame: 48 Months
150mm DEB ITT Cohort - TLR
Any Target lesion revascularisation
Time frame: 60 Months
150mm DEB ITT Cohort - TVR
Any Target lesion revascularisation
Time frame: 6 Months
150mm DEB ITT Cohort - TVR
Any Target lesion revascularisation
Time frame: 12 Months
150mm DEB ITT Cohort - TVR
Any Target lesion revascularisation
Time frame: 24 Months
150mm DEB ITT Cohort - TVR
Any Target lesion revascularisation
Time frame: 36 Months
150mm DEB ITT Cohort - TVR
Any Target lesion revascularisation
Time frame: 48 Months
150mm DEB ITT Cohort - TVR
Any Target lesion revascularisation
Time frame: 60 Months
150mm DEB ITT Cohort - Time to First Clinically-driven TLR (Days)
Time frame: 60 months
150mm DEB ITT Cohort - Time to All-cause Mortality Through 60 Months Post-index Procedure.
All-cause mortality is reported by using the survival estimate of all-cause mortality through 60 months
Time frame: 60 months
150mm DEB ITT Cohort - Primary Sustained Clinical Improvement
Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time frame: 6 months.
150mm DEB ITT Cohort - Primary Sustained Clinical Improvement
Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time frame: 12 months.
150mm DEB ITT Cohort - Primary Sustained Clinical Improvement
Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time frame: 24 months
150mm DEB ITT Cohort - Primary Sustained Clinical Improvement
Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time frame: 36 months
150mm DEB ITT Cohort - Secondary Sustained Clinical Improvement
Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time frame: 6 Months
150mm DEB ITT Cohort - Secondary Sustained Clinical Improvement
Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time frame: 12 Months
150mm DEB ITT Cohort - Secondary Sustained Clinical Improvement
Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time frame: 24 Months
150mm DEB ITT Cohort - Secondary Sustained Clinical Improvement
Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time frame: 36 Months
150mm DEB ITT Cohort - Immediate Hemodynamic Improvement at Post-index Procedure
Immediate hemodynamic improvement is defined as an ABI improvement of ≥ 0.1 or to an ABI ≥ 0.9
Time frame: Post procedure
150mm DEB ITT Cohort - Sustained Hemodynamic Improvement
Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time frame: 6 Months
150mm DEB ITT Cohort - Sustained Hemodynamic Improvement
Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time frame: 12 Months
150mm DEB ITT Cohort - Sustained Hemodynamic Improvement
Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time frame: 24 Months
150mm DEB ITT Cohort - Sustained Hemodynamic Improvement
Sustained hemodynamic improvement is defined as persistent improvement of ABI- values with ≥ 0.1 as compared to baseline values or to an ABI ≥ 0.9 throughout follow-up without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time frame: 36 Months
150mm DEB ITT Cohort - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
Time frame: 6 Months
150mm DEB ITT Cohort - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
Time frame: 12 Months
150mm DEB ITT Cohort - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
Time frame: 24 Months
150mm DEB ITT Cohort - Walking Impairment Evaluation by Walking Impairment Questionnaire (WIQ)
Time frame: 36 Months
150mm DEB ITT Cohort - Health Related Quality of Life Scores (EQ5D Index)
The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.
Time frame: 6 Months
150mm DEB ITT Cohort - Health Related Quality of Life Scores (EQ5D Index)
The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.
Time frame: 12 Months
150mm DEB ITT Cohort - Health Related Quality of Life Scores (EQ5D Index)
The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.
Time frame: 24 Months
150mm DEB ITT Cohort - Health Related Quality of Life Scores (EQ5D Index)
The total EQ-5D-3L UK Index Score was computed using the algorithm specified by the EuroQol Research Foundation with possible values ranging from -0.594 to 1 where higher values are better.
Time frame: 36 Months
150mm DEB ITT Cohort - Device Success
Device success is defined as successful delivery, balloon inflation and deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP)
Time frame: Index-procedure
150mm DEB ITT Cohort - Procedural Success
Procedural Success is defined as residual stenosis of ≤ 50% (non-stented subjects) or ≤ 30% (stented subjects) by visual estimate
Time frame: at procedure
150mm DEB ITT Cohort - Clinical Success
Clinical success is defined as procedural success without procedural complications (mortality, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge
Time frame: prior to discharge
Clinical Cohort ITT - All-cause Mortality
Time frame: 30 days
Clinical Cohort ITT - All-cause Mortality
Time frame: 6 Months
Clinical Cohort ITT - All-cause Mortality
Time frame: 12 Months
Clinical Cohort ITT - All-cause Mortality
Time frame: 24 Months
Clinical Cohort ITT - All-cause Mortality
Time frame: 36 Months
Clinical Cohort ITT - All-cause Mortality
Time frame: 48 Months
Clinical Cohort ITT - All-cause Mortality
The difference in death count calculation between the compliance table (participant flow: 253 deaths) and the event table (244 deaths) is explained as follow: 1. Calendar days (365/year) is used for compliance table whereas 360-day annual cutoff is used for event rate calculation 2. Compliance table used visit window as specified by protocol (60 days for 5-year follow-up) whereas, not window is used for event rate calculation 3. Nine patients died between 1801 and 1885 (1825 + 60) and were therefore not included in the 5-year death rate summary but were included in the compliance summary for patients that died through the upper window of the 60 month visit. 4. The denominator of 1215 for 1800-day event rate includes those who had an event within 1800 days and those who did not have any event but had at least 1740 days of follow-up (1740 is the low bound of the 60-day visit window from the target day of 1800)
Time frame: 60 Months
Clinical Cohort ITT - Clinically-driven TVR
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Time frame: 30 days
Clinical Cohort ITT - Clinically-driven TVR
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Time frame: 6 Months
Clinical Cohort ITT - Clinically-driven TVR
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Time frame: 12 Months
Clinical Clinical Cohort ITT - Clinically-driven TVR
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Time frame: 24 Months
Clinical Cohort ITT - Clinically-driven TVR
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Time frame: 36 Months
Clinical Cohort ITT - Clinically-driven TVR
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Time frame: 48 Months
Clinical Cohort ITT - Clinically-driven TVR
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Time frame: 60 Months
Clinical Cohort ITT - Major Target Limb Amputation
Time frame: 30 days
Clinical Cohort ITT - Major Target Limb Amputation
Time frame: 6 Months
Clinical Cohort ITT - Major Target Limb Amputation
Time frame: 12 Months
Clinical Cohort ITT - Major Target Limb Amputation
Time frame: 24 Months
Clinical Cohort ITT - Major Target Limb Amputation
Time frame: 36 Months
Clinical Cohort ITT - Major Target Limb Amputation
Time frame: 48 Months
Clinical Cohort ITT - Major Target Limb Amputation
Time frame: 60 Months
150mm DEB ITT Cohort - All-cause Mortality
Time frame: 30 days
150mm DEB ITT Cohort - All-cause Mortality
Time frame: 6 Months
150mm DEB ITT Cohort - All-cause Mortality
Time frame: 12 Months
150mm DEB ITT Cohort - All-cause Mortality
Time frame: 24 Months
150mm DEB ITT Cohort - All-cause Mortality
Time frame: 36 Months
150mm DEB ITT Cohort - All-cause Mortality
Time frame: 48 Months
150mm DEB ITT Cohort - All-cause Mortality
Time frame: 60 Months
150mm DEB ITT Cohort - Clinically-driven TVR
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Time frame: 30 days
150mm DEB ITT Cohort - Clinically-driven TVR
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Time frame: 6 Months
150mm DEB ITT Cohort - Clinically-driven TVR
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Time frame: 12 Months
150mm DEB ITT Cohort - Clinically-driven TVR
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Time frame: 24 Months
150mm DEB ITT Cohort - Clinically-driven TVR
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Time frame: 36 Months
150mm DEB ITT Cohort - Clinically-driven TVR
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Time frame: 48 Months
150mm DEB ITT Cohort - Clinically-driven TVR
Clinically-driven TVR is defined as any re-intervention within the target vessel due to symptoms or drop of ABI of ≥ 20% or \> 0.15 when compared to post-index procedure baseline ABI.
Time frame: 60 Months
150mm DEB ITT Cohort - Major Target Limb Amputation
Time frame: 30 days
150mm DEB ITT Cohort - Major Target Limb Amputation
Time frame: 6 Months
150mm DEB ITT Cohort - Major Target Limb Amputation
Time frame: 12 Months
150mm DEB ITT Cohort - Major Target Limb Amputation
Time frame: 24 Months
150mm DEB ITT Cohort - Major Target Limb Amputation
Time frame: 36 Months
150mm DEB ITT Cohort - Major Target Limb Amputation
Time frame: 48 Months
150mm DEB ITT Cohort - Major Target Limb Amputation
Time frame: 60 Months