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FOREST TRIAL - A randomized controlled trial comparing drug-eluting balloons and drug-eluting stents in the treatment of femoropopliteal arterial occlusive disease


- candidate number24055
- NTR NumberNTR5797
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-mrt-2016
- Secondary IDsNL57055.101.16 ABR-nummer
- Public TitleFOREST TRIAL - A randomized controlled trial comparing drug-eluting balloons and drug-eluting stents in the treatment of femoropopliteal arterial occlusive disease
- Scientific TitleRandomized comparison of FemORal drug-Eluting balloons and STents (FOREST)
- ACRONYMFOREST
- hypothesisEndovascular 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
- Healt Condition(s) or Problem(s) studiedStent, Peripheral Arterial Disease
- 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
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2016
- planned closingdate1-aug-2019
- Target number of participants254
- InterventionsSubjects will either be treated with a DEB and provisional stenting with a BMS, or will be primary stented with a DES.
- Primary outcomeFreedom 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
- Timepoints2 year
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESM.D. Hidde Jongsma
- CONTACT for SCIENTIFIC QUERIESM.D. Hidde Jongsma
- Sponsor/Initiator Maasstad Hospital
- Funding
(Source(s) of Monetary or Material Support)
Dutch Endovascular Alliance (DEALL)
- Publications
- Brief summary
- Main changes (audit trail)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.
- RECORD1-mrt-2016 - 23-aug-2016


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