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COMPLETED
NCT02599389
PHASE3

Comparison of Angioplasty/Drug Coated Balloon/Laser + Drug Coated Balloon for Femoropopliteal Artery In-stent Restenosis

Sponsor: University Hospital, Bordeaux

View on ClinicalTrials.gov

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

Interventions

DEVICE

Drug-coated balloons

DEVICE

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