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Study identifier: NCT02599389 Synced from ClinicalTrials.gov · August 06, 2026
● Study status: Completed

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

Condition: Angioplasty, Balloon  ·  Sponsor: University Hospital, Bordeaux

PhasePhase 3
Planned participants222
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

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No contact information is available for this study as per the public registry record.

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Locations (13)

Clinique Rhône DuranceAvignon, France
Centre Hospitalier Universitaire de BesançonBesançon, France
University Hospital of Bordeaux - Hospital PellegrinBordeaux, France
Centre Hospitalier Universitaire de Clermont-FerrandClermont-Ferrand, France
Centre Hospitalier Universitaire de DijonDijon, France
Hospices Civils de LyonLyon, France
Centre Hospitalier Universitaire de NantesNantes, France
Polyclinique Les FleursOllioules, France
Hôpital Européen Georges Pompidou - AP-HP de ParisParis, France
Clinique de L'EuropeRouen, France
Centre Hospitalier Universitaire de St EtienneSaint-Etienne, France
Centre Hospitalier Universitaire de StrasbourgStrasbourg, France

+ 1 more locations — full list on the registry record.

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