PacLitaxel Eluting Balloon Application In Sfa In Stent Restenosis

NCT ID: NCT01587482

Last Updated: 2016-05-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 53 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2015-01-31

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.

Conditions

Peripheral Arterial Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

drug eluting balloon

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.

PacLitaxel Eluting Balloon Application

Intervention Type: PROCEDURE

Stenting is 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.

Interventions

PacLitaxel Eluting Balloon Application

Stenting is 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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thierry Reix, PU-PH

Role: PRINCIPAL_INVESTIGATOR

Amiens's Univeristy Hospital

Eric Ducasse, PU-PH

Role: PRINCIPAL_INVESTIGATOR

Pellegrin's University Hospital

Patrick Lermusiaux, PU-PH

Role: PRINCIPAL_INVESTIGATOR

Lyon's University Hospital

Jean-Marc Pernes, Practitioner

Role: PRINCIPAL_INVESTIGATOR

Antony's private Hospital

Nicolas Louis, PH

Role: PRINCIPAL_INVESTIGATOR

Le Raincy-Montfermeuil Hospital

Antoine Sauget, Practitioner

Role: PRINCIPAL_INVESTIGATOR

Pasteur's private Hospital

Philippe Commeau, Practitioner

Role: PRINCIPAL_INVESTIGATOR

Ollioules private Hospital

Jean-Noel Albertini, PU-PH

Role: PRINCIPAL_INVESTIGATOR

St Etienne University Hospital

Olivier Planché, PH

Role: PRINCIPAL_INVESTIGATOR

Le Plessis-Robinson private hospital (CMC)

Max Amor, PH

Role: PRINCIPAL_INVESTIGATOR

Essey-les-Nancy Private hospital (Polyclinique Pasteur)

Jean-Marie Cardon, Dr

Role: PRINCIPAL_INVESTIGATOR

Nimes private Hospital (clinique des fransiscaines)

Alain Cardon, PH

Role: PRINCIPAL_INVESTIGATOR

Rennes's University Hospital

Locations

Nantes University Hospital

Nantes, , France

Countries

France

References

Bague N, Julia P, Sauguet A, Pernes JM, Chatelard P, Garbe JF, Penillon S, Cardon JM, Commeau P, Planche O, Guyomarch B, Goueffic Y. Femoropopliteal In-stent Restenosis Repair: Midterm Outcomes After Paclitaxel Eluting Balloon Use (PLAISIR Trial). Eur J Vasc Endovasc Surg. 2017 Jan;53(1):106-113. doi: 10.1016/j.ejvs.2016.10.002. Epub 2016 Nov 24.

Reference Type: DERIVED

PMID: 27890526 (View on PubMed)

Other Identifiers

PROG/11/79

Identifier Type: -

Identifier Source: org_study_id