Comparison of Angioplasty/Drug Coated Balloon/Laser + Drug Coated Balloon for Femoropopliteal Artery In-stent Restenosis
NCT: NCT02599389 · COMPLETED
Brief 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.
Frequently Asked Questions
What is Comparison of Angioplasty/Drug Coated Balloon/Laser + Drug Coated Balloon for Femoropopliteal Artery In-stent Restenosis?
Comparison of Angioplasty/Drug Coated Balloon/Laser + Drug Coated Balloon for Femoropopliteal Artery In-stent Restenosis is a clinical trial registered under NCT02599389. Current status: COMPLETED.
What is the status of NCT02599389?
The current status of NCT02599389 (Comparison of Angioplasty/Drug Coated Balloon/Laser + Drug Coated Balloon for Femoropopliteal Artery In-stent Restenosis) is: COMPLETED.
When did Comparison of Angioplasty/Drug Coated Balloon/Laser + Drug Coated Balloon for Femoropopliteal Artery In-stent Restenosis start?
Comparison of Angioplasty/Drug Coated Balloon/Laser + Drug Coated Balloon for Femoropopliteal Artery In-stent Restenosis started on 2015-12.
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Official Source
View on ClinicalTrials.gov →Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.