Randomized comparison of FemORal drug-Eluting balloons and Stents (FOREST TRIAL) - A randomized controlled trial comparing drug-eluting balloons and drug-eluting stents in the treatment of femoropopliteal arterial occlusive disease
- Conditions
- Peripheral arterial occlusive disease (PAOD)10003216
- Registration Number
- NL-OMON50453
- Lead Sponsor
- Stichting DEAll, wetenschappelijke stichting ter bevordering van vasculair wetenschappelijk onderzoek
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 254
• Age >= 18 years
• Patients must be willing to sign an informed consent form
• Rutherford-Baker class 2-6
• At least 1 symptomatic de novo atherosclerotic lesion in the superficial
femoral artery and/or popliteal artery, section P1
• There will be no maximum lesion length
• Diameter of reference vessel between 4 to 7 mm
• The lesion should be a stenosis of at least 50% or an occlusion assessed by
CT-angiography or MR-angiography or assessed by duplex ultrasound (DUS, peak
systolic velocity ratio (PVR) of >2.5)
• At least 1 patent tibial runoff vessel
• Successful passage with guide wire
• Life expectancy <= 1 year
• Restenotic lesions
• Acute femoro-popliteal occlusion
• Recurrent stenosis or occlusion
• Aspirin, Clopidogrel, Heparin or Paclitaxel allergy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint will be 2-year freedom from binary restenosis, defined as<br /><br>a lumen diameter reduction of <50% assessed by duplex ultrasound (peak velocity<br /><br>ratio <2.5). </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcomes will be technical success, target lesion revascularisation,<br /><br>target vessel revascularisation, changes in ankle-brachial index, changes is<br /><br>Rutherford classification, amputation rate and mortality rate.</p><br>