Femme et Homme
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Extrait
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.
Critère d'inclusion
- Peripheral arterial disease