The objective of this study is to perform a non-inferiority analysis of drug-eluting balloons (DEB) with provisional stenting and primary stenting with drug-eluting stents (DES) in the treatment of femoropopliteal arterial occlusive disease. If DEB…
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
The optimal endovascular treatment for femoropopliteal arterial occlusive
disease has yet to be assessed. The most important limitation of percutaneous
treatment is patency. Bare metal stent (BMS) deployment leads to improved
outcomes, in particular in long en complex lesions. Stenting however has its
own limitations as it disrupts the flow pattern, which can lead to stent
thrombosis or in-stent restenosis. Moreover, stents may fracture, which results
in stent occlusion. In the past decade drug-eluting balloons (DEB) and
drug-eluting stents (DES) were introduced. Both DEB and DES, when compared to
conventional techniques, have shown to possess anti-restenotic features.
Study objective
The objective of this study is to perform a non-inferiority analysis of
drug-eluting balloons (DEB) with provisional stenting and primary stenting with
drug-eluting stents (DES) 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.
Study design
Prospective, single blind, randomized, multicenter clinical trial. Subjects
will be randomly assigned to treatment with either DEB or provisional stenting
(spot stenting with bare-metal stents), or with primary stenting with DES.
Follow-up will be obtained at 1,6,12 and 24 months after the intervention. At
these moments patients will undergo physical examination and will be asked to
fill in quality-of-life questionnaires. Prior to the 6, 12 and 24 months visit,
patients will be analyzed by a treadmill test and duplex ultrasound of the
treated artery.
Intervention
Subjects will either be treated with DEB and provisional stenting with a
bare-metal stent, or will be primary stented with a DES.
Study burden and risks
Both DEB and DES are commercially available devices, which are being used as a
standard of care for endovascular treatment of femoropopliteal arterial
occlusive disease. Both devices perform better than uncoated devices without
additional risks.
Follow up consists of 4 outpatient clinic visits, 4 questionnaires, 3 duplex
ultrasounds and 3 treadmill tests. Depending on the local hospital protocol
part of the outpatient clinic visits and additional tests are standard of care.
Patients participating in this trial will be treated according to the best
available endovascular treatment options for 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.
Maasstadweg 21
Rotterdam 3079 DZ
NL
Maasstadweg 21
Rotterdam 3079 DZ
NL
Listed location countries
Age
Inclusion criteria
• 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
Exclusion criteria
• Life expectancy <= 1 year
• Restenotic lesions
• Acute femoro-popliteal occlusion
• Recurrent stenosis or occlusion
• Aspirin, Clopidogrel, Heparin or Paclitaxel allergy
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL57055.101.16 |
| OMON | NL-OMON26991 |