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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Nantes University Hospital
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01587482
First received: February 15, 2012
Last updated: November 16, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Peripheral Arterial Disease
Procedure: PacLitaxel Eluting Balloon Application

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: PacLitaxel Eluting Balloon Application In Sfa In Stent Restenosis

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • Target Lesion Revascularization (TLR) [ Time Frame: at 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Major Adverse Events through [ Time Frame: at 1 year ] [ Designated as safety issue: No ]
  • Target extremity revascularization (TER) [ Time Frame: at 1, 3, 6, 9, 12 and 18 months after surgery ] [ Designated as safety issue: No ]
  • clinical improvement equal or above to a stage according to Rutherford classification without superficial femoral artery revascularization [ Time Frame: at 1, 3, 6, 9, 12 and 18 months ] [ Designated as safety issue: No ]
    to assess primary maintenance of clinical improvement

  • peak systolic velocity index without Target Lesion Revascularization [ Time Frame: at 1, 3, 6, 9, 12 and 18 months ] [ Designated as safety issue: No ]
    to assess primary patency

  • Quality of life assessment by EQ5D questionnaire [ Time Frame: at 1, 3, 6, 9, 12 and 18 mois after surgery ] [ Designated as safety issue: No ]
  • post-angioplasty restenosis [ Time Frame: at 1, 3, 6, 9, 12 and18 months after surgery ] [ Designated as safety issue: No ]
  • drug relief success without balloon break [ Time Frame: during surgery ] [ Designated as safety issue: No ]
  • Length of hospitalization stay [ Time Frame: at 1 year ] [ Designated as safety issue: No ]
  • clinical improvement equal or above to a stage according to Rutherford classification with possible superficial femoral artery surgery [ Time Frame: at 1, 3, 6, 9, 12 and 18 months ] [ Designated as safety issue: No ]
    to assess secondary maintenance of clinical improvement

  • peak systolic velocity index [ Time Frame: at 1 year ] [ Designated as safety issue: No ]
    to assess secondary patency

  • intra-stent restenosis [ Time Frame: at 1, 3, 6, 9, 12 and 18 months after surgery ] [ Designated as safety issue: No ]
    significant whether restenosis >50% and peak systolic velocity index > 2.4


Estimated Enrollment: 100
Study Start Date: December 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01587482

Contacts
Contact: Yann Goueffic, MD, PhD (33) 2 40 16 50 93 yann.goueffic@chu-nantes.fr

Locations
France
Nantes University Hospital Recruiting
Nantes, France, 44093
Contact: Yann Goueffic, MD, PhD    (33) 2 40 16 50 93    yann.goueffic@chu-nantes.fr   
Principal Investigator: Yann Goueffic, Md, PhD         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01587482     History of Changes
Other Study ID Numbers: PROG/11/79
Study First Received: February 15, 2012
Last Updated: November 16, 2012
Health Authority: France: Institutional Ethical Committee

Keywords provided by Nantes University Hospital:
Superficial femoral artery
endovascular
Drug eluting balloon
Paclitaxel

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014