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Clinical Trial 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.


Clinical Trial Description

The publication show that there is probably an effectiveness gradient (expressed as a proportion of patients with in-stent restenosis a 18 months after the intervention of the first stenosis reduction): standard balloons would be less effective than active balloons themselves less effective than in combination with the excimer laser. Reducing the risk of In-Stent Restenosis has major implications for the treatment of patients because it reduces the use of arterial bypass or amputation, if unable to perform revascularization.

Based on these promising results of efficiency, we can hypothesize that the active balloons in combination with the Excimer laser would improve the quality of life of patients while reducing the cost of their treatment, this compared to only assets balloons. This same improvement in quality of life with reduced costs of care would be observed for only assets compared to standard balloons. In health economic terms, it is therefore likely that the strategy combining assets balloons and Excimer laser is dominant over assets balloons themselves dominant over standard balloons. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02599389
Study type Interventional
Source University Hospital, Bordeaux
Contact Eric DUCASSE, MD, PhD
Phone +335 56 79 55 25
Email eric.ducasse@chu-bordeaux.fr
Status Recruiting
Phase Phase 3
Start date December 2015
Completion date May 2020

See also
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Active, not recruiting NCT02648334 - Randomized Comparison of DCB for the Treatment of Superficial Femoral and Popliteal Peripheral Artery Disease N/A
Active, not recruiting NCT04971356 - 1-month DAPT Plus 5-month Ticagrelor Monotherapy Versus 12-month DAPT in Patients With Drug-coated Balloon N/A
Active, not recruiting NCT05175703 - Post-market Registry to Assess the Clinical Performance and Safety of the Passeo-18 Lux in Infrainguinal Arteries N/A
Active, not recruiting NCT05937230 - Drug-coated Balloons and Drug-eluting Stents in Diabetic Patients
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Completed NCT05133921 - The Clinical Efficacy and Safety of Drug-coated Balloon