Comparison of the SUpera® PERipheral System in the Superficial Femoral Artery

Patency of the target lesion was defined as no evidence of restenosis or occlusion within the originally treated lesion based on a centrally-read Color Flow Doppler ultrasound in the absence of target lesion revascularization (TLR). Occlusion and restenosis were defined as no color flow or an increase in peak systolic velocity of \> 2.0 when compared to the proximal normal segment.

Time frame: 12 months

Population: Per ITT set.~Patients are included in the clinical endpoint if:~* They return for their visit within the window~* They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~* The last contact date predated the endpoint time frame but had an event within the endpoint time frame.

Time frame: 30 days

Population: Per ITT set.~Patients are included in the clinical endpoint if:~* They return for their visit within the window~* They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~* The last contact date predated the endpoint time frame but had an event within the endpoint time frame.

A ratio of the highest ankle systolic blood pressure in one leg, usually measured with a 10 cm cuff at the ankle and using a continuous wave Doppler to detect return of blood flow in the anterior tibial and posterior tibial arteries, to the highest of either arm systolic blood pressure. Performed at rest with subject in supine position.

Time frame: 1 month (± 7 Days)

Population: Per ITT set: Patient returned for visit and had ABI measured

A ratio of the highest ankle systolic blood pressure in one leg, usually measured with a 10 cm cuff at the ankle and using a continuous wave Doppler to detect return of blood flow in the anterior tibial and posterior tibial arteries, to the highest of either arm systolic blood pressure. Performed at rest with subject in supine position.

Time frame: Baseline

Population: Per ITT set: Baseline ABI measured prior to study procedure

A ratio of the highest ankle systolic blood pressure in one leg, usually measured with a 10 cm cuff at the ankle and using a continuous wave Doppler to detect return of blood flow in the anterior tibial and posterior tibial arteries, to the highest of either arm systolic blood pressure. Performed at rest with subject in supine position.

Time frame: 12 Months (± 30 Days)

Population: Per ITT set: Patient returned for visit and had ABI measured

A ratio of the highest ankle systolic blood pressure in one leg, usually measured with a 10 cm cuff at the ankle and using a continuous wave Doppler to detect return of blood flow in the anterior tibial and posterior tibial arteries, to the highest of either arm systolic blood pressure. Performed at rest with subject in supine position.

Time frame: 6 Months (± 14 Days)

Population: Per ITT set: Patient returned for visit and had ABI measured

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 = Minor 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. Claudication is defined as a pain, cramps, fatigue, or equivalent in leg muscles occurring during walking that results from inadequate blood supply, usually due to atherosclerotic arterial obstruction.

Time frame: 12 Months (± 30 Days)

Population: Per ITT Set. Patients are included in the Rutherford Becker Score if they completed their visit and Rutherford Becker Classification was performed

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 = Minor 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. Claudication is defined as a pain, cramps, fatigue, or equivalent in leg muscles occurring during walking that results from inadequate blood supply, usually due to atherosclerotic arterial obstruction.

Time frame: Baseline

Population: Per ITT Set. Patients are included in the Rutherford Becker Score if the Rutherford Becker Classification was performed prior to the Study procedure.

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 = Minor 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. Claudication is defined as a pain, cramps, fatigue, or equivalent in leg muscles occurring during walking that results from inadequate blood supply, usually due to atherosclerotic arterial obstruction.

Time frame: 1 Month (± 7 Days)

Population: Per ITT Set. Patients are included in the Rutherford Becker Score if they completed their visit and Rutherford Becker Classification was performed

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 = Minor 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. Claudication is defined as a pain, cramps, fatigue, or equivalent in leg muscles occurring during walking that results from inadequate blood supply, usually due to atherosclerotic arterial obstruction.

Time frame: 36 Months (± 30 Days)

Population: Per ITT Set. Patients are included in the Rutherford Becker Score if they completed their visit and Rutherford Becker Classification was performed

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 = Minor 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. Claudication is defined as a pain, cramps, fatigue, or equivalent in leg muscles occurring during walking that results from inadequate blood supply, usually due to atherosclerotic arterial obstruction.

Time frame: 24 Months (± 30 Days)

Population: Per ITT Set. Patients are included in the Rutherford Becker Score if they completed their visit and Rutherford Becker Classification was performed

Clinical Improvement Compared With Baseline Grade +3 = Markedly Improved, Grade +2 = Moderately Improved, Grade +1 = Minimally Improved, Grade 0 = No Change, Grade -1 = Mildly Worse, Grade -2 = Moderately Worsening, Grade -3 = Markedly Worsening

Time frame: 36 Months (± 30 Days)

Population: Per ITT Set. Patients are included in the Rutherford Becker Score if :They had a baseline Rutherford Becker Classification performed prior to the study procedure.They completed their visit and Rutherford Becker Classification was performed.

Clinical Improvement Compared With Baseline Grade +3 = Markedly Improved, Grade +2 = Moderately Improved, Grade +1 = Minimally Improved, Grade 0 = No Change, Grade -1 = Mildly Worse, Grade -2 = Moderately Worsening, Grade -3 = Markedly Worsening

Time frame: 1 month (± 7 Days)

Population: Per ITT Set. Patients are included in the Rutherford Becker Score if :They had a baseline Rutherford Becker Classification performed prior to the study procedure.They completed their visit and Rutherford Becker Classification was performed.

Clinical Improvement Compared With Baseline Grade +3 = Markedly Improved, Grade +2 = Moderately Improved, Grade +1 = Minimally Improved, Grade 0 = No Change, Grade -1 = Mildly Worse, Grade -2 = Moderately Worsening, Grade -3 = Markedly Worsening

Time frame: 12 Months (± 30 Days)

Population: Per ITT Set. Patients are included in the Rutherford Becker Score if :They had a baseline Rutherford Becker Classification performed prior to the study procedure.They completed their visit and Rutherford Becker Classification was performed.

Clinical Improvement Compared With Baseline Grade +3 = Markedly Improved, Grade +2 = Moderately Improved, Grade +1 = Minimally Improved, Grade 0 = No Change, Grade -1 = Mildly Worse, Grade -2 = Moderately Worsening, Grade -3 = Markedly Worsening

Time frame: 24 Months (± 30 Days)

Population: Per ITT Set. Patients are included in the Rutherford Becker Score if :They had a baseline Rutherford Becker Classification performed prior to the study procedure.They completed their visit and Rutherford Becker Classification was performed.

Device success, defined as achievement of a final residual diameter stenosis of \<50% (by QA), using the assigned treatment only.

Time frame: intraoperative

Population: Per ITT set: Supera implanted. Post-procedure angiogram analyzed by core lab

Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.

Time frame: 1 month (± 7 Days)

Population: Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.

Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.

Time frame: Baseline

Population: Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.

Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.

Time frame: 12 months

Population: Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.

Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.

Time frame: 12 months (± 30 Days)

Population: Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.

Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.

Time frame: 1 month (± 7 Days)

Population: Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.

Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.

Time frame: Baseline

Population: Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.

Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.

Time frame: 1 month (± 7 Days)

Population: Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.

Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.

Time frame: Baseline

Population: Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.

Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.

Time frame: 12 months (± 30 Days)

Population: Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.

Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.

Time frame: 1 month (± 7 Days)

Population: Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.

Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.

Time frame: Baseline

Population: Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.

Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.

Time frame: 12 months (± 30 Days)

Population: Per ITT set. The denominator for exercise testing considers factors such as: patient flow to the physician performing the procedure making it difficult to get a baseline treadmill test; patients with bilateral, multilevel peripheral disease and other underlying diseases and other factors such as age could impact their ability to exercise.

Amputation was defined as the surgical removal of tissue anywhere from the toe to hip in the ipsilateral limb of the target site.

Time frame: 36 months (±30 days)

Population: Per ITT set.~Patients are included in the clinical endpoint if:~* They return for their visit within the window~* They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~* The last contact date predated the endpoint time frame but had an event within the endpoint time frame.

Amputation was defined as the surgical removal of tissue anywhere from the toe to hip in the ipsilateral limb of the target site.

Time frame: 12 months (±30 days)

Population: Per ITT set.~Patients are included in the clinical endpoint if:~* They return for their visit within the window~* They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~* The last contact date predated the endpoint time frame but had an event within the endpoint time frame.

Amputation was defined as the surgical removal of tissue anywhere from the toe to hip in the ipsilateral limb of the target site.

Time frame: 6 months (±14 days)

Population: Per ITT set.~Patients are included in the clinical endpoint if:~* They return for their visit within the window~* They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~* The last contact date predated the endpoint time frame but had an event within the endpoint time frame.

Amputation was defined as the surgical removal of tissue anywhere from the toe to hip in the ipsilateral limb of the target site.

Time frame: 24 months (±30 days)

Population: Per ITT set.~Patients are included in the clinical endpoint if:~* They return for their visit within the window~* They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~* The last contact date predated the endpoint time frame but had an event within the endpoint time frame.

Defined as an improvement in the Rutherford-Becker Clinical Improvement Scale of greater than or equal to one. Grade +3 = Markedly improved. Symptoms are gone or markedly improved. ABI increased to \>0.90. Grade +2 = Moderately improved. Still symptomatic but with improvement in lesion category. ABI increased by 0.10 but not normalized. Grade +1 = Minimally improved. Categorical improvement in symptoms without significant ABI increase (0.10 or less) or vice versa (but not both). Grade 0 = No change. No categorical shift and less than 0.10 change in ABI. Grade -1 = Mildly worse. Either worsening of symptoms or decrease in ABI of 0.10. Grade -2 = Moderate worsening. Deterioration of the subject's condition by one category or unexpected minor amputation. Grade -3 = Marked worsening. Deterioration of the subject's condition by more than one category or major amputation.

Time frame: 36 Months (±30 days)

Population: Per ITT set.~Patients are included in the Limb ischemia improvement if:~They had a baseline Rutherford Becker Clinical Classification done. They return for their visit and Rutherford Becker Clinical Classification was done.

Defined as an improvement in the Rutherford-Becker Clinical Improvement Scale of greater than or equal to one. Grade +3 = Markedly improved. Symptoms are gone or markedly improved. ABI increased to \>0.90. Grade +2 = Moderately improved. Still symptomatic but with improvement in lesion category. ABI increased by 0.10 but not normalized. Grade +1 = Minimally improved. Categorical improvement in symptoms without significant ABI increase (0.10 or less) or vice versa (but not both). Grade 0 = No change. No categorical shift and less than 0.10 change in ABI. Grade -1 = Mildly worse. Either worsening of symptoms or decrease in ABI of 0.10. Grade -2 = Moderate worsening. Deterioration of the subject's condition by one category or unexpected minor amputation. Grade -3 = Marked worsening. Deterioration of the subject's condition by more than one category or major amputation.

Time frame: 12 Months (±30 days)

Population: Per ITT set.~Patients are included in the Limb ischemia improvement if:~They had a baseline Rutherford Becker Clinical Classification done. They return for their visit and Rutherford Becker Clinical Classification was done.

Defined as an improvement in the Rutherford-Becker Clinical Improvement Scale of greater than or equal to one. Grade +3 = Markedly improved. Symptoms are gone or markedly improved. ABI increased to \>0.90. Grade +2 = Moderately improved. Still symptomatic but with improvement in lesion category. ABI increased by 0.10 but not normalized. Grade +1 = Minimally improved. Categorical improvement in symptoms without significant ABI increase (0.10 or less) or vice versa (but not both). Grade 0 = No change. No categorical shift and less than 0.10 change in ABI. Grade -1 = Mildly worse. Either worsening of symptoms or decrease in ABI of 0.10. Grade -2 = Moderate worsening. Deterioration of the subject's condition by one category or unexpected minor amputation. Grade -3 = Marked worsening. Deterioration of the subject's condition by more than one category or major amputation.

Time frame: 1 month (± 7 days)

Population: Per ITT set.~Patients are included in the Limb ischemia improvement if:~They had a baseline Rutherford Becker Clinical Classification done. They return for their visit and Rutherford Becker Clinical Classification was done.

Defined as an improvement in the Rutherford-Becker Clinical Improvement Scale of greater than or equal to one. Grade +3 = Markedly improved. Symptoms are gone or markedly improved. ABI increased to \>0.90. Grade +2 = Moderately improved. Still symptomatic but with improvement in lesion category. ABI increased by 0.10 but not normalized. Grade +1 = Minimally improved. Categorical improvement in symptoms without significant ABI increase (0.10 or less) or vice versa (but not both). Grade 0 = No change. No categorical shift and less than 0.10 change in ABI. Grade -1 = Mildly worse. Either worsening of symptoms or decrease in ABI of 0.10. Grade -2 = Moderate worsening. Deterioration of the subject's condition by one category or unexpected minor amputation. Grade -3 = Marked worsening. Deterioration of the subject's condition by more than one category or major amputation.

Time frame: 24 Months (±30 days)

Population: Per ITT set.~Patients are included in the Limb ischemia improvement if:~They had a baseline Rutherford Becker Clinical Classification done. They return for their visit and Rutherford Becker Clinical Classification was done.

Time frame: 12 months (± 30 Days)

Time frame: 24 months (± 30 Days)

Time frame: 36 months (± 30 Days)

Defined as a composite rate of 1. stent thrombosis, 2. clinically apparent distal embolization (defined as causing end-organ damage, e.g. lower extremity ulceration, tissue necrosis, or gangrene), 3. procedure-related arterial rupture, 4. acute limb ischemia, 5. target limb amputation, 6. procedure related bleeding event requiring transfusion.

Time frame: 36 months (±30 days)

Population: Per ITT set. Patients are included if: they had a procedure related MAVE event, return for their visit within the window, returned for a later visit and the sponsor has information about their clinical status within the endpoint time frame, last contact date predated the endpoint time frame but had an event within the endpoint time frame.

Defined as a composite rate of 1. stent thrombosis, 2. clinically apparent distal embolization (defined as causing end-organ damage, e.g. lower extremity ulceration, tissue necrosis, or gangrene), 3. procedure-related arterial rupture, 4. acute limb ischemia, 5. target limb amputation, 6. procedure related bleeding event requiring transfusion.

Time frame: 12 months (±30 days)

Population: Per ITT set. Patients are included if: they had a procedure related MAVE event, return for their visit within the window, returned for a later visit and the sponsor has information about their clinical status within the endpoint time frame, last contact date predated the endpoint time frame but had an event within the endpoint time frame.

Defined as a composite rate of 1. stent thrombosis, 2. clinically apparent distal embolization (defined as causing end-organ damage, e.g. lower extremity ulceration, tissue necrosis, or gangrene), 3. procedure-related arterial rupture, 4. acute limb ischemia, 5. target limb amputation, 6. procedure related bleeding event requiring transfusion.

Time frame: 24 months (±30 days)

Population: Per ITT set. Patients are included if: they had a procedure related MAVE event, return for their visit within the window, returned for a later visit and the sponsor has information about their clinical status within the endpoint time frame, last contact date predated the endpoint time frame but had an event within the endpoint time frame.

Defined as a composite rate of 1. stent thrombosis, 2. clinically apparent distal embolization (defined as causing end-organ damage, e.g. lower extremity ulceration, tissue necrosis, or gangrene), 3. procedure-related arterial rupture, 4. acute limb ischemia, 5. target limb amputation, 6. procedure related bleeding event requiring transfusion.

Time frame: 30 days (±7 days)

Population: Per ITT set. Patients are included if: they had a procedure related MAVE event, return for their visit within the window, returned for a later visit and the sponsor has information about their clinical status within the endpoint time frame, last contact date predated the endpoint time frame but had an event within the endpoint time frame.

Defined as a composite rate of 1. stent thrombosis, 2. clinically apparent distal embolization (defined as causing end-organ damage, e.g. lower extremity ulceration, tissue necrosis, or gangrene), 3. procedure-related arterial rupture, 4. acute limb ischemia, 5. target limb amputation, 6. procedure related bleeding event requiring transfusion.

Time frame: 6 Months (±14 days)

Population: Per ITT set. Patients are included if: they had a procedure related MAVE event, return for their visit within the window, returned for a later visit and the sponsor has information about their clinical status within the endpoint time frame, last contact date predated the endpoint time frame but had an event within the endpoint time frame.

Defined as device success with \< 50% residual stenosis immediately after stent placement, mean trans-stenotic pressure gradient less than 5 mmHg, and without the occurrence of death, amputation or repeat revascularization of the target lesion during the hospital stay.

Time frame: intraoperative

Population: Per ITT set. Supera implanted. Post-procedure angiogram analyzed by core lab Occurrence of death, amputation or TLR during the hospital stay

The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.

Time frame: 6 months (± 14 Days)

Population: Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the PAQ Questionnaire at the visit

The PAQ assesses Peripheral arterial disease (PAD)-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.

Time frame: Baseline

Population: Per ITT set.~Patients are included in the QoL endpoint if:~They completed the PAQ Questionnaire prior to the study procedure

The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.

Time frame: 12 months (± 30 Days)

Population: Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the PAQ Questionnaire at the visit

The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.

Time frame: 12 months (± 30 Days)

Population: Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the PAQ Questionnaire at the visit

The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.

Time frame: 6 months (± 14 Days)

Population: Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the PAQ Questionnaire at the visit

The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.

Time frame: Baseline

Population: Per ITT set.~Patients are included in the QoL endpoint if:~They completed the PAQ Questionnaire prior to the study procedure

The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.

Time frame: Baseline

Population: Per ITT set.~Patients are included in the QoL endpoint if:~They completed the PAQ Questionnaire prior to the study procedure

The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.

Time frame: 12 months (± 30 Days)

Population: Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the PAQ Questionnaire at the visit

The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.

Time frame: 6 months (± 14 Days)

Population: Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the PAQ Questionnaire at the visit

The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.

Time frame: Baseline

Population: Per ITT set.~Patients are included in the QoL endpoint if:~They completed the PAQ Questionnaire prior to the study procedure

The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.

Time frame: 6 months (± 14 Days)

Population: Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the PAQ Questionnaire at the visit

The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.

Time frame: 12 months (± 30 Days)

Population: Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the PAQ Questionnaire at the visit

The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.

Time frame: 12 months (± 30 Days)

Population: Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the PAQ Questionnaire at the visit

The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.

Time frame: 6 months (± 14 Days)

Population: Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the PAQ Questionnaire at the visit

The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.

Time frame: Baseline

Population: Per ITT set.~Patients are included in the QoL endpoint if:~They completed the PAQ Questionnaire prior to the study procedure

The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.

Time frame: 12 months (± 30 Days)

Population: Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the PAQ Questionnaire at the visit

The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.

Time frame: 6 months (± 14 Days)

Population: Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the PAQ Questionnaire at the visit

The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.

Time frame: Baseline

Population: Per ITT set.~Patients are included in the QoL endpoint if:~They completed the PAQ Questionnaire prior to the study procedure

The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.

Time frame: Baseline

Population: Per ITT set.~Patients are included in the QoL endpoint if:~They completed the PAQ Questionnaire prior to the study procedure

The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.

Time frame: 6 months (± 14 Days)

Population: Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the PAQ Questionnaire at the visit

The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.

Time frame: 12 months (± 30 Days)

Population: Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the PAQ Questionnaire at the visit

The Medical Outcomes Study 12-Item Short form survey (SF-12) was used to assess generic QoL.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. Physical and mental summary scores from the SF-12 are scaled to a U.S. population mean of 50 and standard deviation of 10 (higher scores are better). Multiple groups have suggested minimum clinically important changes in SF-12 summary scores to be greater than 2-2.5 points, and moderate changes to be greater than 5 points.

Time frame: 6 Months (± 14 Days)

Population: Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the SF-12 Questionnaire at the visit.

The Medical Outcomes Study 12-Item Short form survey (SF-12) was used to assess generic QoL.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. Physical and mental summary scores from the SF-12 are scaled to a U.S. population mean of 50 and standard deviation of 10 (higher scores are better). Multiple groups have suggested minimum clinically important changes in SF-12 summary scores to be greater than 2-2.5 points, and moderate changes to be greater than 5 points.

Time frame: 12 Months (± 30 Days)

Population: Per ITT set.~Patients are included in the QoL endpoint if:~They completed the follow-up visit and the SF-12 Questionnaire at the visit

The Medical Outcomes Study 12-Item Short form survey (SF-12) was used to assess generic QoL. 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. Physical and mental summary scores from the SF-12 are scaled to a U.S. population mean of 50 and standard deviation of 10 (higher scores are better). Multiple groups have suggested minimum clinically important changes in SF-12 summary scores to be greater than 2-2.5 points, and moderate changes to be greater than 5 points.

Time frame: Baseline

Population: Per ITT set.~Patients are included in the QoL endpoint if:~They completed the SF-12 Questionnaire prior to the study procedure

Secondary safety endpoint was a combined rate of death at 30 (± 7) days, or TLR, index limb amputation, and an increase in Rutherford-Becker Classification by 2 classes at 12 months (± 30 Days) (comparing pre- to post-procedural assessments).

Time frame: 12 months (± 30 Days)

Population: Per ITT set.~Patients are included in the clinical endpoint if:~* They return for their visit within the window~* They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~* The last contact date predated the endpoint time frame but had an event within the endpoint time frame.

Secondary safety endpoint was a combined rate of death at 30 (± 7) days, or TLR, index limb amputation, and an increase in Rutherford-Becker Classification by 2 classes (comparing pre- to post-procedural assessments).

Time frame: 24 months (± 30 Days)

Population: Per ITT set.~Patients are included in the clinical endpoint if:~* They return for their visit within the window~* They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~* The last contact date predated the endpoint time frame but had an event within the endpoint time frame.

Secondary safety endpoint was a combined rate of death at 30 (± 7) days, or TLR, index limb amputation, and an increase in Rutherford-Becker Classification by 2 classes at 36 months (± 30 Days)(comparing pre- to post-procedural assessments).

Time frame: 36 months (± 30 Days)

Population: Per ITT set.~Patients are included in the clinical endpoint if:~* They return for their visit within the window~* They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~* The last contact date predated the endpoint time frame but had an event within the endpoint time frame.

Patency of the target lesion was defined as no evidence of restenosis or occlusion within the originally treated lesion based on a centrally-read Color Flow Doppler ultrasound in the absence of target lesion revascularization (TLR). Occlusion and restenosis were defined as no color flow or an increase in peak systolic velocity of \> 2.0 when compared to the proximal normal segment.

Time frame: 6 Months (± 14 days)

Population: Per ITT set. Patients are included if: they return for visit within the window, returned for a later visit \& sponsor has information on their clinical status within the endpoint time frame, the last contact date predated the endpoint time frame but had an event within the endpoint time frame, had a duplex ultrasound performed \& analyzed by core lab

Patency of the target lesion was defined as no evidence of restenosis or occlusion within the originally treated lesion based on a centrally-read Color Flow Doppler ultrasound in the absence of target lesion revascularization (TLR). Occlusion and restenosis were defined as no color flow or an increase in peak systolic velocity of \> 2.0 when compared to the proximal normal segment.

Time frame: 6 Months (± 14 days)

Population: Per ITT set. Patients are included if: they return for visit within the window, returned for a later visit \& sponsor has information on their clinical status within the endpoint time frame, the last contact date predated the endpoint time frame but had an event within the endpoint time frame, had a duplex ultrasound performed \& analyzed by core lab

Patency of the target lesion was defined as no evidence of restenosis or occlusion within the originally treated lesion based on a centrally-read Color Flow Doppler ultrasound in the absence of target lesion revascularization (TLR). Occlusion and restenosis were defined as no color flow or an increase in peak systolic velocity of \> 2.0 when compared to the proximal normal segment.

Time frame: 12 Months (±30 days)

Population: Per ITT set. Patients are included if they return for visit within the window, returned for a later visit \& sponsor has information on their clinical status within the endpoint time frame, the last contact date predated the endpoint time frame but had an event within the endpoint time frame, had a duplex ultrasound performed \& analyzed by core lab

Stent fractures were analyzed by X-ray evaluation by a designated core laboratory and defined as type I, II, III, IV or V. Stent fracture classification * Type I - a single strut fracture only. * Type II - multiple single nitinol stent fractures that can occur at different sites. * Type III - multiple nitinol stent fractures resulting in complete transverse linear fracture but without stent displacement. * Type IV - a complete transverse linear type III fracture with stent displacement. * Type V - a spiral dissection of a stent.

Time frame: 12 months (± 30 Days)

Population: Per ITT set: Supera implanted. Patient returned for visit and had x-ray of stent. X-ray analyzed by core lab

Stent fractures were analyzed by X-ray evaluation by a designated core laboratory and defined as type I, II, III, IV or V.

Time frame: 24 months (± 30 Days)

Population: Per ITT set: Supera implanted. Patient returned for visit and had x-ray of stent. X-ray analyzed by core lab

Stent fractures were analyzed by X-ray evaluation by a designated core laboratory and defined as type I, II, III, IV or V.

Time frame: 36 months (± 30 Days)

Population: Per ITT set: Supera implanted. Patient returned for visit and had x-ray of stent. X-ray analyzed by core lab

Defined as any repeat percutaneous intervention with or without evidence of stenosis ≥ 50%, to improve blood flow inside or within 5 mm proximally and/or distally of the treated target lesion.

Time frame: 24 months (± 30 Days)

Population: Per ITT set.~Patients are included in the clinical endpoint if:~* They return for their visit within the window~* They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~* The last contact date predated the endpoint time frame but had an event within the endpoint time frame.

Defined as any repeat percutaneous intervention with or without evidence of stenosis ≥ 50%, to improve blood flow inside or within 5 mm proximally and/or distally of the treated target lesion.

Time frame: 36 months (± 30 Days)

Population: Per ITT set.~Patients are included in the clinical endpoint if:~* They return for their visit within the window~* They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~* The last contact date predated the endpoint time frame but had an event within the endpoint time frame.

Defined as any repeat percutaneous intervention with or without evidence of stenosis ≥ 50%, to improve blood flow inside or within 5 mm proximally and/or distally of the treated target lesion.

Time frame: 12 months (± 30 Days)

Population: Per ITT set.~Patients are included in the clinical endpoint if:~* They return for their visit within the window~* They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~* The last contact date predated the endpoint time frame but had an event within the endpoint time frame.

Defined as any repeat percutaneous intervention with or without evidence of stenosis ≥ 50%, to improve blood flow inside or within 5 mm proximally and/or distally of the treated target lesion.

Time frame: 6 months (± 14 Days)

Population: Per ITT set.~Patients are included in the clinical endpoint if:~* They return for their visit within the window~* They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~* The last contact date predated the endpoint time frame but had an event within the endpoint time frame.

Defined as any repeat percutaneous intervention or bypass surgery performed in the target vessel at 6 months post-procedure.

Time frame: 6 months (± 14 days)

Population: Per ITT set.~Patients are included in the clinical endpoint if:~* They return for their visit within the window~* They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~* The last contact date predated the endpoint time frame but had an event within the endpoint time frame.

Defined as any repeat percutaneous intervention or bypass surgery performed in the target vessel at 12 months post-procedure.

Time frame: 12 months (±30 days)

Population: Per ITT set.~Patients are included in the clinical endpoint if:~* They return for their visit within the window~* They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~* The last contact date predated the endpoint time frame but had an event within the endpoint time frame.

Defined as any repeat percutaneous intervention or bypass surgery performed in the target vessel at 24 months post-procedure.

Time frame: 24 months (±30 days)

Population: Per ITT set.~Patients are included in the clinical endpoint if:~* They return for their visit within the window~* They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~* The last contact date predated the endpoint time frame but had an event within the endpoint time frame.

Defined as any repeat percutaneous intervention or bypass surgery performed in the target vessel at 36 months post-procedure.

Time frame: 36 months (±30 days)

Population: Per ITT set.~Patients are included in the clinical endpoint if:~* They return for their visit within the window~* They came back for a later visit and the sponsor has information about their clinical status within the endpoint time frame~* The last contact date predated the endpoint time frame but had an event within the endpoint time frame.

Technical (lesion) success, defined as the attainment of \<50% residual stenosis by Quantitative Angiography (QA) by any percutaneous method as determined by the Angiographic core laboratory.

Time frame: intraoperative

Population: Per ITT set: Post-procedure angiogram analyzed by core lab