iVascular has announced the completion of enrolment of patients in its T.I.N.T.I.N. (Treatment with the Luminor DCB and the iVolution self-expanding stent) study.
The effectiveness of drug-coated balloons (DCB) to inhibit restenosis in symptomatic superficial femoral artery (SFA) lesions has been proven in many studies. However, the longer and the more complex these lesions are, the more bailout stenting or spot stenting is necessary. Regarding self-expanding stents, the main advantage is the achievement of maximum arterial lumen gain. Nevertheless, the increase of restenosis in long-term results has been demonstrated in several studies, iVascular states in a press release.
The release adds, “What if we combine both therapies resulting in perfect treatment for complex lesions? A combination between the properties of Luminor, the DCB with the best outcomes in SFA and popliteal arteries, and the iVolution self-expanding stent, known for its high flexibility and radial force, can be the solution to avoid bailout stenting and restenosis in long-term results.”
The T.I.N.T.I.N. study aims at evaluating the 12-month outcomes of a combination therapy of the Luminor DCB and iVolution stent, in long TASC C and D femoropopliteal lesions. This prospective, multicentre, physician-initiated study is focused on the following endpoints:
Freedom from clinically-driven target lesion revascularisation (TLR) at 12 months.
Primary patency rate at six- and 12-month follow-up
Freedom from clinically-driven TLR at six-month follow-up
Clinical success at follow-up
Serious adverse events.
Koen Deloose (AZ Sint Blasius Dendermonde, Belgium), T.I.N.T.I.N. study principal investigator states, “The enrolment 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.”
The enrolment of 100 patients has been completed and the first outcomes of the study will be presented at LINC 2019.