PacLitaxel Eluting Balloon Application In Sfa In Stent Restenosis

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

Interventions

PROCEDURE

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.

Sponsors & Collaborators

• Nantes University Hospital

  lead OTHER

Principal Investigators

• Thierry Reix, PU-PH · Amiens's Univeristy Hospital

• Eric Ducasse, PU-PH · Pellegrin's University Hospital

• Patrick Lermusiaux, PU-PH · Lyon's University Hospital

• Jean-Marc Pernes, Practitioner · Antony's private Hospital

• Nicolas Louis, PH · Le Raincy-Montfermeuil Hospital

• Antoine Sauget, Practitioner · Pasteur's private Hospital

• Philippe Commeau, Practitioner · Ollioules private Hospital

• Jean-Noel Albertini, PU-PH · St Etienne University Hospital

• Olivier Planché, PH · Le Plessis-Robinson private hospital (CMC)

• Max Amor, PH · Essey-les-Nancy Private hospital (Polyclinique Pasteur)

• Jean-Marie Cardon, Dr · Nimes private Hospital (clinique des fransiscaines)

• Alain Cardon, PH · Rennes's University Hospital

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-12-31

Primary Completion

2012-12-31

Completion

2015-01-31

Countries

• France

Study Locations