PacLitaxel Eluting Balloon Application In Sfa In Stent Restenosis

Completed

• Conditions: Peripheral Arterial Disease
• Interventions: Procedure: PacLitaxel Eluting Balloon Application

• Registration Number: NCT01587482
• Lead Sponsor: Nantes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-02-15
• Study First Submitted QC: 2012-04-26
• Study First Posted: 2012-04-30
• Primary Completion: 2012-12
• Study Completion: 2015-01
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-19
• Last Update Posted: 2016-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
drug eluting balloon	PacLitaxel Eluting Balloon Application	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.

Primary Outcome Measures

Name	Time	Method
Target Lesion Revascularization (TLR)	at 1 year

Secondary Outcome Measures

Name	Time	Method
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	to assess primary maintenance of clinical improvement
Length of hospitalization stay	at 1 year
peak systolic velocity index	at 1 year	to assess secondary patency
drug relief success without balloon break	during surgery
Target extremity revascularization (TER)	at 1, 3, 6, 9, 12 and 18 months after 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	to assess secondary maintenance of clinical improvement
peak systolic velocity index without Target Lesion Revascularization	at 1, 3, 6, 9, 12 and 18 months	to assess primary patency
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	significant whether restenosis \>50% and peak systolic velocity index \> 2.4

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, France