Drug Eluting Balloons Versus Standard Percutaneous Transluminal Angioplasty in Infra-popliteal Arteries in Patients With Critical Limb Ischemia: a Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 60
- Primary Endpoint
- binary restenosis rate
Study Overview
Brief Summary
Percutaneous transluminal angioplasty (PTA) of infra-popliteal arteries in patients suffering peripheral arterial occlusive disease (PAOD) provides good results in terms of limb salvage. During the last decade, drug eluting balloons (DEB) were found to be an effective tool for the treatment of atherosclerotic disease in several arterial districts. Aim of this study is to compare results of DEB PTA versus standard PTA of infra-popliteal district in patients with CLI, from a single-centre prospective randomized trial.
Detailed Description
Percutaneous transluminal angioplasty (PTA) of infra-popliteal arteries in patients suffering peripheral arterial occlusive disease (PAOD) provides good results in terms of limb salvage. Nevertheless, this treatment is still burdened by consistent restenosis and reintervention rates up to 68% and 50%, respectively.
During the last decade, drug eluting balloons (DEB) were found to be an effective tool for the treatment of atherosclerotic disease in several arterial districts. DEBs are coated by antimitotic drug (usually paclitaxel) in order to inhibit endothelial cells proliferation. Paclitaxel effectiveness is due to the drug lipophilicity.
A short (1 to 3 minutes) balloon inflation at the target vessel level is sufficient to deliver a therapeutic dose of paclitaxel, lasting in situ thereafter for months.
The effectiveness of DEBs has been already proven in coronary as well as in femoro-popliteal district: DEBs have improved primary patency rates both in de novo lesions and in femoro-popliteal intrastent restenosis.
A role for DEBs in the treatment of infra-popliteal lesions district in patients with critical limb ischemia (CLI) has been also described, however results in that specific anatomical site are still controversial.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients with CLI (Rutherford classes 4, 5, 6);
- •stenosis and/or complete occlusion of P3 popliteal artery segment;
- •stenosis and/or complete occlusion of at least 1 leg vessel >40 mm in length;
- •life-expectancy >12 months;
- •possibility to perform angiogram at 12-months follow-up.
Exclusion Criteria
- •life-expectancy <12 months;
- •iodinated contrast media or paclitaxel allergy;
- •impossibility to undergo dual antiplatelet therapy.
Arms & Interventions
DEB PTA
Devices: paclitaxel drug eluting balloon PTA
Intervention: DEB PTA (Procedure)
standard PTA
devices: standard balloon PTA
Intervention: Standard PTA (Procedure)
Outcomes
Primary Outcomes
binary restenosis rate
Time Frame: 12-months
binary restenosis rate has been defined as lumen loss \>50% at DSA
Secondary Outcomes
- clinically driven target lesion revascularization (CD-TLR) rate(12-months)
- major amputations rate(12-months)
- wound healing rate(12-months)
- target vessel occlusion rate(12-months)
Investigators
Francesco Pompeo
Head of vascular surgery division
Neuromed IRCCS