Status:
COMPLETED
Randomized Trial of IN.PACT Admiral® Drug Coated Balloon vs Standard PTA for the Treatment of SFA and Proximal Popliteal Arterial Disease
Lead Sponsor:
Medtronic Endovascular
Conditions:
Peripheral Arterial Disease (PAD)
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
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 o...
Detailed Description
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 me...
Eligibility Criteria
Inclusion
- General
- 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
- \- Target vessel is the superficial femoral artery and/or proximal popliteal artery (above the knee)
- General
Exclusion
- Patient unwilling or unlikely to comply with follow-up schedule
- Stroke or STEMI within 3 months prior enrolment
- Angiographic
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2017
Estimated Enrollment :
331 Patients enrolled
Trial Details
Trial ID
NCT01175850
Start Date
September 1 2010
End Date
April 1 2017
Last Update
May 16 2017
Active Locations (1)
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1
Klinikum Rosenheim Institut für Diagnostische und Interventionelle Radiologie
Rosenheim, Pettenkoferstr, Germany, 83022