Status:
COMPLETED
Drug Eluting Balloon Angioplasty Versus Nitinol Stent Implantation in the Superficial Femoral Artery
Lead Sponsor:
Instituto Dante Pazzanese de Cardiologia
Collaborating Sponsors:
Medtronic
Conditions:
Peripheral Arterial Disease
Arterial Occlusive Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate whether the results of drug eluting balloon are non-inferior to the Nitinol stent implantation in the femoropopliteal segment.
Eligibility Criteria
Inclusion
- Patients over 18 years with critical lower limb ischemia,
- Ruhtherford 3 or higher,
- with angiographic documentation of greater than 70% or occlusion in the superficial femoral artery,
- with a maximum extension of 10 cm stenosis.
- The popliteal artery and at least one leg artery must be patent.
Exclusion
- Pregnancy,
- thrombophilia,
- coagulation disorders,
- presence of active or recent bleeding,
- severe allergy to iodinated contrast,
- renal or hepatic disease,
- acute limb ischemia,
- prior surgical bypass or angioplasty (with or without stent) on the target artery,
- obstructive disease (stenosis\> 50%) of the aortoiliac segment ipsilateral to the target (if the aortoiliac is pre-treated, the patient may be included)
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2019
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT02212470
Start Date
July 1 2014
End Date
October 1 2019
Last Update
June 10 2021
Active Locations (1)
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1
Instituto Dante Pazzanese de Cardiologia
São Paulo, Brazil, 04012909