Enrollment Completed in TINTIN Trial of Combined Treatment With iVascular's Luminor DCB and iVolution BMS

November 14, 2018—iVascular announced the completion of patient enrollment in the TINTIN clinical trial, which is evaluating the combined therapy of the company's Luminor drug-coated balloon (DCB) and its iVolution self-expandable bare-metal stent (BMS) for symptomatic superficial femoral artery and popliteal artery lesions.

TINTIN is a prospective, multicenter, physician-initiated study that seeks to evaluate the 12-month outcomes of the combination therapy in long TransAtlantic Inter-Society Consensus C and D femoropopliteal lesions. The trial enrolled 100 patients. The first outcomes of the study will be presented at LINC 2019, the Leipzig Interventional Course held January 22–25 in Leipzig, Germany.

The study's primary endpoint is freedom from clinically driven target lesion revascularization (CD-TLR) at 12 months. Secondary endpoints include primary patency rates at 6- and 12-month follow-up, technical success, freedom from CD-TLR at 6-month follow-up, clinical success at follow-up, and freedom from serious adverse events.

The TINTIN study's Principal Investigator is Koen Deloose, MD, from AZ Sint Blasius in Dendermonde, Belgium. In the company's announcement, Dr. Deloose commented, “The enrollment has just been completed, and we expect outstanding results from this trial, as both Luminor DCB and iVolution self-expanding stent are products that have proven their safety and efficacy in previous studies.”

According to iVascular, the study hopes to determine if combining the Luminor DCB with the iVolution BMS will help avoid bailout stenting and restenosis in long-term results.

The paclitaxel-coated Luminor device is designed for dilatation of stenosis located in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, as well as for the treatment of obstructive lesions of arteriovenous fistulas (either original or artificial). In the EffPac trial, the Luminor DCB demonstrated significant improvement in Rutherford classification at 12 months (90.6%) versus plain old balloon angioplasty.

The iVolution self-expanding stent is indicated for the treatment of de novo or restenotic lesions in peripheral arteries located under the aortic arch and for palliation of the biliary tract. The outcomes of the EVOLUTION trial demonstrated the device's flexibility and its high-quality nitinol as an effective treatment of femoropopliteal lesions, stated the company.