NCT01587482

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 30, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

May 20, 2016

Status Verified

May 1, 2016

Enrollment Period

1 year

First QC Date

February 15, 2012

Last Update Submit

May 19, 2016

Conditions

Peripheral Arterial Disease

Keywords

Superficial femoral arteryendovascularDrug eluting balloonPaclitaxel

Outcome Measures

Primary Outcomes (1)

  • Target Lesion Revascularization (TLR)

    at 1 year

Secondary Outcomes (11)

  • 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

    at 1, 3, 6, 9, 12 and 18 months

  • peak systolic velocity index without Target Lesion Revascularization

    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

  • +6 more secondary outcomes

Study Arms (1)

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

Interventions

PacLitaxel Eluting Balloon ApplicationPROCEDURE

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.

drug eluting balloon

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nantes University Hospital

Nantes, 44093, France

Location

Related Publications (1)

  • 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.

    PMID: 27890526DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2012

First Posted

April 30, 2012

Study Start

December 1, 2011

Primary Completion

December 1, 2012

Study Completion

January 1, 2015

Last Updated

May 20, 2016

Record last verified: 2016-05

Locations

FR(1)