Femoro-popliteal, femoral, popliteal, drug-eluting, balloon, stent Femoropopliteaal, femoraal, popliteaal, drug-eluting, ballon, stent
Conditions
Interventions
Subjects will either be treated with a DEB and provisional stenting with a BMS, or will be primary stented with a DES.
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: • Age ≥ 18 years • Patients must be willing to sign an informed consent form • Rutherford-Baker class 2-5 • 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
Exclusion criteria
Exclusion criteria: • Life expectancy ≤ 1 year • Restenotic lesions • Acute femoro-popliteal occlusion • Recurrent stenosis or occlusion • Aspirin, Clopidogrel, Heparin or Paclitaxel allergy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| • Technical success, defined as residual stenosis < 30% after treatment assessed on angiography during procedure. • Procedural success, defined as procedure without complication and with technical success • Target lesion revascularization (TLR) during follow up, defined as any repeated revascularization of the target lesion to maintain patency • Target vessel revascularization (TVR), defined as repeat intervention of target vessel to maintain patency • Primary patency, defined as freedom from binary restenosis and TLR during follow up • Changes in Ankle-brachial index (ABI), assessed by treadmill test. In patients with CLI only a resting ABI will be performed • Changes in Rutherford-Baker classification • Improvement in disease-related health status, functioning and quality of life. As defined by a Dutch translation of the Peripheral Artery Questionnaire (PAQ). • Major amputation rate (above the ankle) • Mortality (all-cause mortality) • Any other complication regarding the treatment of the femoropopliteal lesion | — |
Contacts
Public ContactHidde Jongsma
Maasstad Hospital Rotterdam Department of Vascular Surgery
Outcome results
None listed