PacLitaxel Eluting Balloon Application In Sfa In Stent Restenosis (PLAISIR)

Nantes University Hospital (NUH)

Status: Completed

Conditions: Peripheral Arterial Disease

Treatments: Procedure: PacLitaxel Eluting Balloon Application

Study type: Observational

Funder types: Other

Identifiers

NCT01587482

PROG/11/79

Details and patient eligibility

About

Nowadays, stenting is became a standard of care in revascularization for superficial femoral artery (SFA) atherosclerotic lesions. However, the Achilles' heel of this technique remains in-stent restenosis (ISR). While most of local therapies have failed to demonstrate significant benefit, studies for the treatment of SFA ISR are lacking and percutaneous transluminal angioplasty remains the current standard of care for this indication. Recent studies have shown successful results of drug eluting balloon in the treatment of SFA de-novo lesions and of coronary ISR. FREERIDE, a French prospective cohort has been set up to evaluate the safety and the efficacy of drug eluting balloon (DEB) for the treatment of SFA atherosclerotic lesions.

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 years old
• Symptomatic patient according to Rutherford Class 1, 2, 3, 4 or 5
• Clinical degradation by at least 1 Rutherford stage or absence of healing of all skin lesions
• Symptoms related to SFA ISR defined by PSVR > 2.4 within 3 to 24 months after SFA stenting of de novo atherosclerotic lesions. Each patient may have either one or both limbs treated in the study
• The target ISR lesion is fully comprised between the origin of the SFA and distally the femoropopliteal crossover (crossing by SFA of medial rim of femur in the PA projection)
• Adequate SFA inflow and outflow either pre-existing or successfully re-established (outflow defined as patency of at least one infragenicular artery)
• The target lesion must no extend beyond the stent margin
• Successful crossing of the target lesion, inflow and outflow lesions with a guidewire
• Patient belongs to the French health care system
• Written informed consent

Exclusion criteria

• No atheromatous disease
• Asymptomatic lesion
• Known allergies to heparin, aspirin, other anti-coagulant/antiplatelet therapies, and/or paclitaxel
• Acute limb ischemia
• Patient on oral anticoagulation therapy
• Target lesion requires / has been pre-treated with alternative therapy such as: DES, laser, atherectomy, cryoplasty, cutting/scoring balloon, etc.
• Life expectancy < 1 year
• Patient involved in another trial
• Refusing patient
• Pregnancy

Trial design

53 participants in 1 patient group

drug eluting balloon

Description:

In this observationnal study, the intervention of interest is the use of drug eluting balloon in stent restenosis. Only the treated patients were included in this cohort.

Treatment:

Procedure: PacLitaxel Eluting Balloon Application