Informations générales (source: ClinicalTrials.gov)
Economic Evaluation Comparing Standard Balloon Angioplasty Versus Drug-eluted Balloon or Laser-Excimer in Association With Drug-eluted Balloon in the Treatment of Femoropopliteal Artery In-stent Restenosis.
Interventional
Phase 3
University Hospital, Bordeaux (Voir sur ClinicalTrials)
décembre 2015
mai 2020
11 juin 2026
The aim of this multicenter triple-arm randomized study is to compare two innovative
techniques with the gold standard currently used and providing unsatisfactory results for
the In-Stent Restenosis (ISR) treatment in femoro-popliteal arteries. This protocol
compares the use of drug-coated balloons (paclitaxel - antimitotic) used alone or in
association with the Excimer Laser to recalibrate the vessel lumen into the stent by
destroying the whole fibrous material to the standard angioplasty using plain balloons.
INTACT study main objective is to assess cost-effectiveness ratio of the treatment of
femoropopliteal artery in-stent restenosis by comparing these two innovative strategies
and the standard one in terms of cost per Qaly (Quality adjusted life-years) gained at 18
months from a collective perspective.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Europeen Georges Pompidou | Contact (sur clinicalTrials) | ||||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Hospitalier Universitaire de Besançon - 25030 - Besançon - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Dijon - 21079 - Dijon - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Nantes - 44093 - Nantes - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de St Etienne - 42055 - Saint-Etienne - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Strasbourg - 67091 - Strasbourg - France | Contact (sur clinicalTrials) | ||||
| Clinique de L'Europe - 76100 - Rouen - France | Contact (sur clinicalTrials) | ||||
| Clinique Pasteur - 31076 - Toulouse - France | Contact (sur clinicalTrials) | ||||
| Clinique Rhône Durance - 84000 - Avignon - France | Contact (sur clinicalTrials) | ||||
| Hospices Civils de Lyon - 69000 - Lyon - France | Contact (sur clinicalTrials) | ||||
| Polyclinique Les Fleurs - 83190 - Ollioules - France | Contact (sur clinicalTrials) | ||||
| University Hospital of Bordeaux - Hospital Pellegrin - 33000 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Hospitalier Universitaire de Clermont-Ferrand - 63000 - Clermont-Ferrand - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
- Patient of age > 18 years
- Patient with previously peripheral implanted stent(s) located in or extending to the
popliteal artery
- Patient who received this stent between 3-36 months before inclusion
- Patient with one or more in-stent restenosis lesion(s) > 70% in the same arterial
segment in association with clinical symptoms of claudication or an critical limb
ischemia with Rutherford classification of 2, 3, 4 or 5
- Reference vessel diameter between 4 and 7 mm
- Patient affiliated to a social security regimen
- EC-approved consent form signed by the participant and the investigator (must be
signed prior initiation of any study related intervention)
Exclusion Criteria:
- Life expectancy >18 months
- Patient already included in this study (recruitment of the contralateral leg is not
allowed)
- Patient contraindicated for the use of antiplatelet therapy
- Pregnant or breast-feeding women
- Patient with a target limb infection being treated
- Patient with a procoagulant blood disease
- Patient with history of contrast agents allergies
- Patient with intolerance to paclitaxel
- Patient with severe renal impairment (GFR <30 ml / min / 1.73 m²) or patient with a
creatinine clearance <15 ml / min
- External compression of previously implanted stent
- Patient participating in any clinical trial using another investigational drug or
product which could interfere with the interpretation of the trial results.
- Patient under trusteeship or guardianship
Angiographic exclusion criteria :
- Inflow (above) severe lesion >70% or occlusion untreated satisfactorily (residual
lesion> 50%) before the management of the target lesion
- Perforation, dissection or lesions on the arterial network access requiring an
assumption prior to randomization
- Stent fracture grade 4 or 5 at the target lesion