TINTIN Trial to Evaluate Combined Therapy With iVascular's Luminor DCB and iVolution BMS
September 29, 2017—iVascular, based in Barcelona, Spain, recently announced the initiation of the TINTIN trial, which is evaluating the combined therapy of the company's Luminor drug-coated balloon (DCB) and iVolution self-expandable bare-metal stent (BMS).
TINTIN is a prospective, investigator-initiated, nonrandomized, multicenter trial that will investigate the 12-month safety and efficacy of combined Luminor DCB and iVolution BMS treatment in Trans-Atlantic Inter-Society Consensus C and D femoropopliteal atherosclerotic lesions.
The study's Principal Investigator, Koen Deloose, MD, with AZ Sint Blasius in Dendermonde, Belgium, enrolled the first two patients on September 22.
In the company's announcement, Dr. Deloose commented, "We are excited to drive the first multicenter study evaluating the dual-therapy DCB plus BMS in real-life Trans-Atlantic Inter-Society Consensus C and D lesions. Performing this with a drug-eluting balloon that has shown the best results in a randomized controlled trial as of today, and a self-expandable stent that has proven its efficacy in the EVOLUTION trial, we expect outstanding results in the most challenging SFA lesions."