FOREST TRIAL - A randomized controlled trial comparing drug-eluting balloons and drug-eluting stents in the treatment of femoropopliteal arterial occlusive disease
- Conditions
- Femoro-popliteal, femoral, popliteal, drug-eluting, balloon, stentFemoropopliteaal, femoraal, popliteaal, drug-eluting, ballon, stent
- Registration Number
- NL-OMON26991
- Lead Sponsor
- A
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 254
Inclusion Criteria
•Age ≥ 18 years
•Patients must be willing to sign an informed consent form
Exclusion Criteria
•Life expectancy ≤ 1 year
•Restenotic lesions
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Freedom from binary restenosis at 2 years of follow up, defined as a reduction of >50% assessed by duplex ultrasound (peak velocity ratio (PVR) >2.5)
- Secondary Outcome Measures
Name Time Method