PacLitaxel Eluting Balloon Application In Sfa In Stent Restenosis

Nantes University Hospital1 site in 1 country53 target enrollmentDecember 2011

ConditionsPeripheral Arterial Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Peripheral Arterial Disease
Sponsor: Nantes University Hospital
Enrollment: 53
Locations: 1
Primary Endpoint: Target Lesion Revascularization (TLR)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

December 2011

End Date

January 2015

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Nantes University Hospital

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Target Lesion Revascularization (TLR)

Time Frame: at 1 year

Secondary Outcomes

Length of hospitalization stay(at 1 year)
Major Adverse Events through(at 1 year)
clinical improvement equal or above to a stage according to Rutherford classification without superficial femoral artery revascularization(at 1, 3, 6, 9, 12 and 18 months)
peak systolic velocity index(at 1 year)
Target extremity revascularization (TER)(at 1, 3, 6, 9, 12 and 18 months after surgery)
drug relief success without balloon break(during surgery)
clinical improvement equal or above to a stage according to Rutherford classification with possible superficial femoral artery surgery(at 1, 3, 6, 9, 12 and 18 months)
peak systolic velocity index without Target Lesion Revascularization(at 1, 3, 6, 9, 12 and 18 months)
post-angioplasty restenosis(at 1, 3, 6, 9, 12 and18 months after surgery)
Quality of life assessment by EQ5D questionnaire(at 1, 3, 6, 9, 12 and 18 mois after surgery)
intra-stent restenosis(at 1, 3, 6, 9, 12 and 18 months after surgery)