No registrations found.
ID
Source
Brief title
Health condition
Femoro-popliteal, femoral, popliteal, drug-eluting, balloon, stent
Femoropopliteaal, femoraal, popliteaal, drug-eluting, ballon, stent
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
• 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
Background summary
Background: The optimal endovascular treatment for femoropopliteal arterial occlusive disease has yet to be assessed. Patency rates are disappointing after conventional angioplasty. Stenting techniques have improved outcomes, in particular in long and complex lesion. The presence of a stent however, also has limitations despite the improved outcomes. Intra-arterial stenting may lead to stent thrombosis and flow pattern disruption, which may result in stent fracture or in-stent restenosis and may advocate techniques where nothing is left behind.
In the past decade drug-eluting balloons (DEB) and drug-eluting stents (DES) were introduced. Both DEB and DES have proven to posses anti restenotic features in comparison to conventional techniques.
The objective of this study is to perform a non-inferiority analysis of drug-eluting balloons with provisional stenting and primary stenting with drug-eluting stents in the treatment of femoropopliteal arterial occlusive disease. If DEB with provisional stenting turns out to be non-inferior to primary stenting with DES, than DEB may be a favourable technique, since the postoperative long-term limitations of stents will be restricted.
Methods/Design This is a prospective, randomized, controlled, single-blind, multi-center trail. The study population consists of human volunteers aged over 18, with chronic, symptomatic peripheral arterial occlusive disease (Rutherford classification 2 to 5) due to de novo stenotic or occlusive lesions of the superficial femoral artery or popliteal artery (only P1).
Subjects will either be treated with DEB and provisional stenting with a bare-metal stent, or will be primary stented with a DES. A total of 254 patients will be included (ratio 1:1).
The primary endpoint will be 2-year freedom from binary restenosis, defined as a lumen diameter reduction of <50% assessed by duplex ultrasound (peak velocity ratio <2.5). Secondary outcomes will be technical success, target lesion revascularisation, target vessel revascularisation, changes in ankle-brachial index, changes is Rutherford classification, amputation rate and mortality rate.
Study objective
Endovascular treatment of femoropopliteal arterial occlusive disease with drug-eluting balloons with provisional stenting leads to the same angiographic and clinical outcomes as primary stenting with a drug-eluting stent
Study design
2 year
Intervention
Subjects will either be treated with a DEB and provisional stenting with a BMS, or will be primary stented with a DES.
Hidde Jongsma
Maasstadweg 21
Rotterdam 3079 DZ
The Netherlands
(+31) 10 2911911
jongsmah@maasstadziekenhuis.nl
Hidde Jongsma
Maasstadweg 21
Rotterdam 3079 DZ
The Netherlands
(+31) 10 2911911
jongsmah@maasstadziekenhuis.nl
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
• Life expectancy ≤ 1 year
• Restenotic lesions
• Acute femoro-popliteal occlusion
• Recurrent stenosis or occlusion
• Aspirin, Clopidogrel, Heparin or Paclitaxel allergy
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5662 |
| NTR-old | NTR5797 |
| CCMO | NL57055.101.16 |
| OMON | NL-OMON50453 |