Randomized Trial of IN.PACT Admiral® Drug Coated Balloon vs Standard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease

Randomized Trial of IN.PACT Admiral(TM) Drug Coated Balloon vs Standard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease

The objective of this Study is to evaluate the safety and efficacy of the IN.PACT Admiral® drug coated PTA balloon, utilized for the dilatation of the narrowed sections of the artery, as compared to other standard (non drug coated) PTA balloons. The IN.PACT Admiral, besides the mechanical dilatation effect typical of all PTA balloons, releases a drug (paclitaxel) from the balloon surface into the vessel walls. This drug absorption is intended to limit the chances and the entity of artery re-narrowing over time.

The efficacy of the IN.PACT Admiral balloon will be evaluated by assessing the primary patency rate of the treated arteries in the thighs of all patients included in the Study. Primary patency is a measure of the durability up to 1 year of the free lumen in the artery as restored during the procedure and is based on:

• the need for re-dilatation of the previously treated vessel segment
• an ultrasound examination The safety of the IN.PACT Admiral will be assessed by evaluating the incidence of deaths, amputations and re-dilatation of the pre-treated arteries in all patients included in the Study.

The IN.PACT SFA Trial enrolled in 2 phases: IN.PACT SFA I and IN.PACT SFA II. The 150-patient IN.PACT SFA I phase is intended to support the second phase IN.PACT SFA II IDE trial with congruent design and protocol. Aggregate data from the two phases is intended to provide statistical power for the 12-month primary safety and effectiveness endpoints.

General Inclusion Criteria:

• Age ≥18 years and ≤85 years
• Patient or patient's legal representative is informed of the nature of the study, agrees to participate and has signed an EC approved consent form

Angiographic Inclusion Criteria:

- Target vessel is the superficial femoral artery and/or proximal popliteal artery (above the knee)

General Exclusion Criteria:

• Patient unwilling or unlikely to comply with follow-up schedule
• Stroke or STEMI within 3 months prior enrolment

Angiographic Exclusion Criteria:

- Acute or sub-acute thrombus in the target vessel