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

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Procedure: PacLitaxel Eluting Balloon Application

• Study Type: Observational
• Enrollment (Actual): 53

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44093
    • Nantes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

From December 2011 to December 2012 at 13 hospitals in France, we will include patients with symptomatic atherosclerotic lesions related to superficial femoral artery in-stent restenosis to undergo endovascular repair by paclitaxel drug eluting balloon. 100 patients will be included.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Target Lesion Revascularization (TLR)	at 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Adverse Events through		at 1 year
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 without superficial femoral artery revascularization	to assess primary maintenance of clinical improvement	at 1, 3, 6, 9, 12 and 18 months
peak systolic velocity index without Target Lesion Revascularization	to assess primary patency	at 1, 3, 6, 9, 12 and 18 months
Quality of life assessment by EQ5D questionnaire		at 1, 3, 6, 9, 12 and 18 mois after surgery
post-angioplasty restenosis		at 1, 3, 6, 9, 12 and18 months after surgery
drug relief success without balloon break		during surgery
Length of hospitalization stay		at 1 year
clinical improvement equal or above to a stage according to Rutherford classification with possible superficial femoral artery surgery	to assess secondary maintenance of clinical improvement	at 1, 3, 6, 9, 12 and 18 months
peak systolic velocity index	to assess secondary patency	at 1 year
intra-stent restenosis	significant whether restenosis >50% and peak systolic velocity index > 2.4	at 1, 3, 6, 9, 12 and 18 months after surgery

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Thierry Reix, PU-PH, Amiens's Univeristy Hospital; Principal Investigator: Eric Ducasse, PU-PH, Pellegrin's University Hospital; Principal Investigator: Patrick Lermusiaux, PU-PH, Lyon's University Hospital; Principal Investigator: Jean-Marc Pernes, Practitioner, Antony's private Hospital; Principal Investigator: Nicolas Louis, PH, Le Raincy-Montfermeuil Hospital; Principal Investigator: Antoine Sauget, Practitioner, Pasteur's private Hospital; Principal Investigator: Philippe Commeau, Practitioner, Ollioules private Hospital; Principal Investigator: Jean-Noel Albertini, PU-PH, St Etienne University Hospital; Principal Investigator: Olivier Planché, PH, Le Plessis-Robinson private hospital (CMC); Principal Investigator: Max Amor, PH, Essey-les-Nancy Private hospital (Polyclinique Pasteur); Principal Investigator: Jean-Marie Cardon, Dr, Nimes private Hospital (clinique des fransiscaines); Principal Investigator: Alain Cardon, PH, Rennes's University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: February 15, 2012
• First Submitted That Met QC Criteria: April 26, 2012
• First Posted (Estimate): April 30, 2012

Study Record Updates

• Last Update Posted (Estimate): May 20, 2016
• Last Update Submitted That Met QC Criteria: May 19, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Paclitaxel; endovascular; Drug eluting balloon; Superficial femoral artery
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: PROG/11/79