CVT-SFA First in Human Trial for Treatment of Superficial Femoral Artery or Proximal Popliteal Artery

Rate of Ipsilateral Embolic Events of the Study Limb

This end point was to asses the Rate of Ipsilateral Embolic Events of the Study Limb.

Time frame: 12 months

Rate of Clinically-driven Revascularization

This end point was to asses the Rate of Clinically-driven Revascularization.

Time frame: 6 months

Rate of Clinically-driven Revascularization

This end point was to asses the Rate of Clinically-driven Revascularization.

Time frame: 12 months

Patency Rate

The patency results achieved in the CVT-SFA Study translate into meaningful patient benefits as demonstrated by the improvement of secondary outcomes measures.

Time frame: 12 months

Rate of Vascular Access Site Complication

Rate of vascular access site complication defined as the combined rate of hematoma, AV fistula or a pseudoaneurysm that required intervention, such as surgical repair or transfusion, prolonged hospital stay, or required a new hospital admission.

Time frame: 12 months

Lesion Success

Lesion success (per device), defined as achievement of a final in-lesion residual diameter stenosis of \<50% (by QA), using any device after wire passage through the lesion. Pre- and post-dilatation of the lesion with a non-study device is considered part of assigned device treatment.

Time frame: 12 months

Technical Success

Technical success (per device), defined as achievement of a final in-lesion residual diameter stenosis of \<50% (by QA), using the CVT Everolimus-coated PTA Catheter without a device malfunction after wire passage through the lesion. Pre- and postdilatation are considered part of assigned device treatment.

Time frame: 12 months

Clinical Success

Clinical success (per subject) defined as technical success without the occurrence of major adverse events (MAE) during the procedure.

Time frame: 12 months

Procedural Success

Procedural success (per subject) defined as lesion success without the occurrence of major adverse events during procedure.

Time frame: 12 months

Change in Ankle-Brachial Index (ABI)

Change in Ankle-Brachial Index (ABI) is calculated as the difference between the ABI values at baseline and at follow-up visits. ABI is measured using a Doppler ultrasound or Oscillo metric method to assess peripheral arterial function. A change of ≥0.1 in ABI values from baseline to follow-up is considered clinically significant. The data presented in the Outcome Measure table reflects the percentage of participants who experienced a significant change in ABI from baseline.

Time frame: Discharge

Change in Ankle-Brachial Index (ABI)

Change in Ankle-Brachial Index (ABI) is calculated as the difference between the ABI values at baseline and at follow-up visits. ABI is measured using a Doppler ultrasound or Oscillo metric method to assess peripheral arterial function. A change of ≥0.1 in ABI values from baseline to follow-up is considered clinically significant. The data presented in the Outcome Measure table reflects the percentage of participants who experienced a significant change in ABI from baseline.

Time frame: 6 months

Change in Ankle-Brachial Index (ABI)

Change in Ankle-Brachial Index (ABI) is calculated as the difference between the ABI values at baseline and at follow-up visits. ABI is measured using a Doppler ultrasound or Oscillo metric method to assess peripheral arterial function. A change of ≥0.1 in ABI values from baseline to follow-up is considered clinically significant. The data presented in the Outcome Measure table reflects the percentage of participants who experienced a significant change in ABI from baseline.

Time frame: 12 months

Walking Impairment Questionnaire - Patient Perceived Change in Walking Difficulty

The WIQ (Walking Impairment Questionnaire) score is a numerical representation of a person's walking capacity, derived from their responses to a series of questions about walking difficulty. Individuals are asked to rate degree of difficulty of various activities with responses ranging from 0 (lowest possible function) to 4 (highest possible function). Questions within each category are based on degree of difficulty, according to approximate number of feet, stairs, or miles per hour for distance, stair-climbing, and speed scores, respectively. Scores are then divided by maximum number of points and presented on a scale of 0% to 100%, where 0% represents lowest possible score (i.e., answering "unable" for all questions in that category) and 100% represents the highest possible score (i.e., indicating "none" with regard to difficulty for all questions in that category). A higher score indicates less difficulty with walking, while a lower score signifies greater difficulty with walking.

Time frame: Pre-Procedure to 6 months and 12 months

Walking Impairment Questionnaire - Patient Perceived Change in Walking Speed

The WIQ (Walking Impairment Questionnaire) score is a numerical representation of a person's walking capacity, derived from their responses to a series of questions about walking difficulty. Individuals are asked to rate the degree of difficulty of various activities with responses ranging from 0 (lowest possible function) to 4 (highest possible function). Questions within each category are based on the degree of difficulty, according to the approximate number of feet, stairs, or miles per hour for the distance, stair-climbing, and speed scores, respectively. Scores are then divided by the maximum number of points and presented on a scale of 0% to 100%, where 0%represents the lowest possible score (i.e., answering "unable" for all questions in that category) and 100% represents the highest possible score (i.e., indicating "none" with regard to difficulty for all questions in that category). Higher scores signify less difficulty in maintaining speed while walking.

Time frame: Pre-Procedure to 6 months and 12 months

Walking Impairment Questionnaire - Patient Perceived Change in Walking Impairment

The WIQ (Walking Impairment Questionnaire) score is a numerical representation of a person's walking capacity, derived from their responses to a series of questions about walking difficulty. Individuals are asked to rate the degree of difficulty of various activities with responses ranging from 0 (lowest possible function) to 4 (highest possible function). Questions within each category are based on the degree of difficulty, according to the approximate number of feet, stairs, or miles per hour for the distance, stair-climbing, and speed scores, respectively. Scores are then divided by the maximum number of points and presented on a scale of 0% to 100%, where 0%represents the lowest possible score (i.e., answering "unable" for all questions in that category) and 100% represents the highest possible score (i.e., indicating "none" with regard to difficulty for all questions in that category). A higher score indicates less perceived walking impairment.

Time frame: Pre-Procedure to 6 months and 12 months

Walking Test: Change in Walking Distance

The Walking Test is a standard test used to evaluate functionality in patients with peripheral artery disease (PAD). This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes.

Time frame: Baseline to 6 months and 12 months

Treadmill Test: Change in Walking Distance

Treadmill walking test is a standard test used to evaluate functionality in patients with peripheral artery disease (PAD).

Time frame: Baseline to 6 months and 12 months

Change in Rutherford Classification

Participants were graded using the Rutherford Classification, which stages PAD based on symptoms and clinical findings. Class 0 asymptomatic , normal treadmill or reactive hyperemia test. Class 1 mild claudication completes treadmill exercise; AP after exercise \> 50 mm Hg but at least 20 mm Hg lower than resting value. Class 2-3 more severe symptoms cannot complete standard treadmill exercise, and AP after exercise \< 50 mm Hg. Class 4 critical limb ischemia resting AP \< 40 mm Hg, flat or barely pulsatile ankle or metatarsal PVR; TP \< 30 mm Hg. Class 5 minor tissue loss-nonhealing ulcer, focal gangrene with diffuse pedal ischemia and resting AP \< 60 mm Hg, ankle or metatarsal PVR flat or barely pulsatile; TP \< 40 mm Hg. The lower the RB Class the better the outcome.

Time frame: Pre-procedure

Change in Rutherford Classification

Participants were graded using the Rutherford Classification, which stages PAD based on symptoms and clinical findings. Class 0 asymptomatic , normal treadmill or reactive hyperemia test. Class 1 mild claudication completes treadmill exercise; AP after exercise \> 50 mm Hg but at least 20 mm Hg lower than resting value. Class 2-3 more severe symptoms cannot complete standard treadmill exercise, and AP after exercise \< 50 mm Hg. Class 4 critical limb ischemia resting AP \< 40 mm Hg, flat or barely pulsatile ankle or metatarsal PVR; TP \< 30 mm Hg. Class 5 minor tissue loss-nonhealing ulcer, focal gangrene with diffuse pedal ischemia and resting AP \< 60 mm Hg, ankle or metatarsal PVR flat or barely pulsatile; TP \< 40 mm Hg. The lower the RB Class the better the outcome.

Time frame: 6 months

Change in Rutherford Classification

Participants were graded using the Rutherford Classification, which stages PAD based on symptoms and clinical findings. Class 0 asymptomatic , normal treadmill or reactive hyperemia test. Class 1 mild claudication completes treadmill exercise; AP after exercise \> 50 mm Hg but at least 20 mm Hg lower than resting value. Class 2-3 more severe symptoms cannot complete standard treadmill exercise, and AP after exercise \< 50 mm Hg. Class 4 critical limb ischemia resting AP \< 40 mm Hg, flat or barely pulsatile ankle or metatarsal PVR; TP \< 30 mm Hg. Class 5 minor tissue loss-nonhealing ulcer, focal gangrene with diffuse pedal ischemia and resting AP \< 60 mm Hg, ankle or metatarsal PVR flat or barely pulsatile; TP \< 40 mm Hg. The lower the RB Class the better the outcome.

Time frame: 12 months