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Comparison of Angioplasty/Drug Coated Balloon/Laser + Drug Coated Balloon for Femoropopliteal Artery In-stent Restenosis
Sponsor: University Hospital, Bordeaux
Summary
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.
Official title: 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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
222
Start Date
2015-12
Completion Date
2020-05
Last Updated
2026-06-10
Healthy Volunteers
No
Conditions
Interventions
Drug-coated balloons
Excimer Laser
Locations (13)
Clinique Rhône Durance
Avignon, France
Centre Hospitalier Universitaire de Besançon
Besançon, France
University Hospital of Bordeaux - Hospital Pellegrin
Bordeaux, France
Centre Hospitalier Universitaire de Clermont-Ferrand
Clermont-Ferrand, France
Centre Hospitalier Universitaire de Dijon
Dijon, France
Hospices Civils de Lyon
Lyon, France
Centre Hospitalier Universitaire de Nantes
Nantes, France
Polyclinique Les Fleurs
Ollioules, France
Hôpital Européen Georges Pompidou - AP-HP de Paris
Paris, France
Clinique de L'Europe
Rouen, France
Centre Hospitalier Universitaire de St Etienne
Saint-Etienne, France
Centre Hospitalier Universitaire de Strasbourg
Strasbourg, France
Clinique Pasteur
Toulouse, France