Barcelona, November 14th of 2018.- iVascular S.L.U. has announced the completion of enrollment 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.
What if we combine both therapies resulting on 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.
T.I.N.T.I.N. study aims at evaluating the 12-month outcomes of a combination therapy of iVascular Luminor DCB and iVolution stent, in long TASC C and D femoropopliteal lesions. This prospective, multi-center, physician-initiated study is focused on the following endpoints:
- Freedom from clinically-driven TLR at 12 months.
- Primary patency rate at 6- and 12-month follow-up
- Technical success
- Freedom from clinically-driven TLR at 6-month follow-up.
- Clinical success at follow-up.
- Serious adverse events.
Dr. Koen Deloose (AZ Sint Blasius Dendermonde, Belgium), T.I.N.T.I.N. study principal investigator stated “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”.
The enrollment of 100 patients has been completed and the first outcomes of the study will be presented at LINC 2019.
About Luminor DCB
Luminor is a Paclitaxel Coated Balloon specifically 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, whether original or artificial. The balloon is coated with a homogeneous mixture of Paclitaxel by means of iVascular proprietary technology Transfertech. This technology applies a multilayer of the drug by spraying nanodrop through ultrasound to have less drug loss during manipulation and navigation. EFFPAC trial, with Luminor DCB is the only RCT demonstrating any significant Rutherford improvement at 12 months vs POBA (90.6%).
Luminor DCB: EFFPAC Trial
About iVolution Self Expandable Stent
The peripheral self-expanding stent system iVolution, is indicated for the treatment of de novo or restenotic lesions in peripheral arteries located under the aortic arch and for palliation of biliary tract. The outcomes of the EVOLUTION trial demonstrate that the outstanding flexibility and the high-quality nitinol of the stent makes iVolution an effective alternative to treat femoropopliteal lesions.
iVolution: EVOLUTION Trial