Last updated on February 2018

Tack Optimized Drug Coated Balloon Angioplasty Study of the Tack Endovascular System in Femoropoliteal Arteries


Brief description of study

This is an Outside the United States, post-CE Mark, multi-center, single-arm, non-blinded study designed to investigate the safety and efficacy of the Tack Endovascular System. This study will evaluate subjects with PAD who receive PTA (with a drug-coated balloon (DCB)) in the SFA and in popliteal arteries, ranging in diameter from 2.5mm to 6.0mm and lesion lengths of 20mm and 150mm, and have a resulting dissection(s) type(s) A through F. TOBA III will also evaluate the safety and efficacy of the device when used to treat a sub-group presenting with longer lesions of >150mm and 250mm.

Clinical Study Identifier: NCT02802306

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Marc Bosiers, MD

A.Z. St. Blasius Hospital
Dendermonde, Belgium
4.39miles
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