Clinical trial NCT01587482: PacLitaxel Eluting Balloon Application In Sfa In Stent Restenosis
Official title: PacLitaxel Eluting Balloon Application In Sfa In Stent Restenosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Arterial Disease
Keywords: Superficial femoral artery
endovascular
Drug eluting balloon
Paclitaxel
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2012-04-30
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: Target Lesion Revascularization (TLR)
timeFrame: at 1 year
Secondary outcomes:
measure: Major Adverse Events through
timeFrame: at 1 year
measure: Target extremity revascularization (TER)
timeFrame: at 1, 3, 6, 9, 12 and 18 months after surgery
measure: clinical improvement equal or above to a stage according to Rutherford classification without superficial femoral artery revascularization
timeFrame: at 1, 3, 6, 9, 12 and 18 months
measure: peak systolic velocity index without Target Lesion Revascularization
timeFrame: at 1, 3, 6, 9, 12 and 18 months
measure: Quality of life assessment by EQ5D questionnaire
timeFrame: at 1, 3, 6, 9, 12 and 18 mois after surgery
measure: post-angioplasty restenosis
timeFrame: at 1, 3, 6, 9, 12 and18 months after surgery
measure: drug relief success without balloon break
timeFrame: during surgery
measure: Length of hospitalization stay
timeFrame: at 1 year
measure: clinical improvement equal or above to a stage according to Rutherford classification with possible superficial femoral artery surgery
timeFrame: at 1, 3, 6, 9, 12 and 18 months
measure: peak systolic velocity index
timeFrame: at 1 year
measure: intra-stent restenosis
timeFrame: at 1, 3, 6, 9, 12 and 18 months after surgery
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
affiliation: Amiens's Univeristy Hospital
name: Thierry Reix, PU-PH
role: PRINCIPAL_INVESTIGATOR
affiliation: Pellegrin's University Hospital
name: Eric Ducasse, PU-PH
role: PRINCIPAL_INVESTIGATOR
affiliation: Lyon's University Hospital
name: Patrick Lermusiaux, PU-PH
role: PRINCIPAL_INVESTIGATOR
affiliation: Antony's private Hospital
name: Jean-Marc Pernes, Practitioner
role: PRINCIPAL_INVESTIGATOR
affiliation: Le Raincy-Montfermeuil Hospital
name: Nicolas Louis, PH
role: PRINCIPAL_INVESTIGATOR
affiliation: Pasteur's private Hospital
name: Antoine Sauget, Practitioner
role: PRINCIPAL_INVESTIGATOR
affiliation: Ollioules private Hospital
name: Philippe Commeau, Practitioner
role: PRINCIPAL_INVESTIGATOR
affiliation: St Etienne University Hospital
name: Jean-Noel Albertini, PU-PH
role: PRINCIPAL_INVESTIGATOR
affiliation: Le Plessis-Robinson private hospital (CMC)
name: Olivier Planché, PH
role: PRINCIPAL_INVESTIGATOR
affiliation: Essey-les-Nancy Private hospital (Polyclinique Pasteur)
name: Max Amor, PH
role: PRINCIPAL_INVESTIGATOR
affiliation: Nimes private Hospital (clinique des fransiscaines)
name: Jean-Marie Cardon, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Rennes's University Hospital
name: Alain Cardon, PH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.