NCT02599389

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

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.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 222 (estimated)
• Sponsor: University Hospital, Bordeaux · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Angioplasty, Balloon

Interventions

Type	Name	Description
DEVICE	Drug-coated balloons
DEVICE	Excimer Laser

Timeline

• Start date: 2015-12-01
• Primary completion: 2020-05-01
• Completion: 2020-05-01
• First posted: 2015-11-06
• Last updated: 2019-11-19

Locations

15 sites across 1 country: France