The objective of this study is to assess the safety and effectiveness of the BD LPVCS for the treatment of stenosis and occlusion in the common and/or external iliac artery and the superficial femoral artery (SFA)/proximal popliteal artery (PPA). Primary Endpoints (with Hypothesis Testing) The primary endpoint for each of the cohorts will be evaluated against literature-based Performance Goals (PGs).

Iliac Cohort: A composite safety and effectiveness measure defined as device and/or procedure-related death or myocardial infarction (MI) through 30 days, or clinically driven target lesion revascularization (CD-TLR), or target limb major amputation (at or above the ankle), or target lesion restenosis through 9 months post-index procedure.

SFA/PPA Cohort:
Primary Safety: Freedom from Major Adverse Events (MAEs) through 30 days, defined as the following: All cause death, Target limb major amputation (at or above the ankle), CD-TLR

Primary Effectiveness: Primary Patency at 12 months. Key Secondary Endpoints (with Hypothesis Testing) Iliac Cohort: Improvement of Rutherford Category at 12 months when compared to Baseline.

SFA/PPA Cohort: Improvement of Rutherford Category at 12 months when compared to Baseline.

Secondary Endpoints (without Hypothesis Testing) Iliac Cohort: The rate of relevant MAEs for this endpoint, defined as device and/or procedure-related death or MI through 30 days, or any CD-TLR or target limb major amputation (at or above the ankle) through 9 months post-index procedure; Access site major hematoma hemorrhage (2g/dl hemoglobin (Hgb) drop or requiring transfusion) or vessel injury requiring intervention or surgery through 30 days post-index procedure; Acute Lesion Success; Acute Procedural Success; Acute Technical Success; Freedom from CD-TLR through 9, 12, 24, and 36 months post-index procedure; Freedom from Target Vessel Revascularization (TVR) through 9, 12, 24, and 36 months post-index procedure; Sustained Clinical Success through 30 days and 9, 12, 24, and 36 months post-index procedure; Primary Patency through 9, 12, 24, and 36 months post-index procedure; Primary Assisted Patency through 9, 12, 24, and 36 months post-index procedure; Secondary Patency through 9, 12, 24, and 36 months post-index procedure; Quality of Life assessed using the Walking Impairment Questionnaire (WIQ) score change from baseline at 30 days and 9, 12, 24, and 36 months post-index procedure.

SFA/PPA Cohort: The rate of relevant MAEs for this endpoint, defined as device and/or procedure-related death or MI through 30 days, or any CD-TLR or target limb major amputation (at or above the ankle) through 12 months post-index procedure; Access site major hematoma hemorrhage (2g/dl Hgb drop or requiring transfusion) or vessel injury requiring intervention or surgery through 30 days post-index procedure; Acute Lesion Success; Acute Procedural Success; Acute Technical Success; Freedom from CD-TLR through 6, 12, 24, and 36 months post-index procedure; Freedom from TVR through 6, 12, 24, and 36 months post-index procedure; Sustained Clinical Success through 30 days and 6, 12, 24, and 36 months post-index procedure; Primary Patency through 6, 24, and 36 months post-index procedure; Primary Assisted Patency through 6, 12, 24, and 36 months post-index procedure; Secondary Patency through 6, 12, 24, and 36 months post-index procedure; Quality of Life assessed using the WIQ score change from baseline at 30 days and 6, 12, 24, and 36 months post-index procedure.

Exploratory Endpoints (without hypothesis testing) Iliac Cohort: Rate of relevant MAEs, defined for this endpoint as device and/or procedure-related death or MI or CD-TLR or target limb major amputation (at or above the ankle) through 30 days post-index procedure. SFA/PPA Cohort: 12-month primary patency of Rutherford Category 2-4 subjects in the SFA/PPA cohort compared to the Vascular InterVentional Advances (VIVA) PG; 12-month primary pa

You may be eligible for this study if you meet the following criteria:

• Conditions: Medical Research
• Age: 99 years or below
• Gender: All