iVascular SLU has announced the initiation of the TINTIN trial, evaluating the combined therapy of Luminor drug-coated balloon (DCB) and iVolution self-expandable stent.
The TINTIN study is prospective, investigator-initiated, non-randomised, multicentre trial, investigating the 12-month safety and efficacy of combined Luminor DCB and iVolution self-expandable stent in TASC C and D femoropopliteal atherosclerotic lesions.
“Both Luminor and iVolution have already demonstrated their safety and efficacy in previous studies” stated Lluis Duocastella, CEO of iVascular SLU. “The TINTIN trial is the next step to prove their combined benefit for the patient with the most complex lesions”.
Koen Deloose (AZ Sint Blasius Dendermonde, Belgium), is the TINTIN trial principal investigator. Deloose enrolled the first two patients on 22 September. “We are excited to drive the first multicentre study evaluating the dual therapy DCB with bare metal stent in real-life TASC C and D lesions. Performing this with a drug-eluting balloon that has shown the best results in a randomised controlled trial as of today, and a self-expandable stent that has proven its efficacy in EVOLUTION trial, we expect outstanding results in the most challenging superficial femoral artery lesions” Deloose said.