NCT02802306

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

Tack Optimized Drug Coated Balloon Angioplasty in the Superficial Femoral and Proximal Popliteal Arteries Using the Tack Endovascular System™

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 201 (actual)
• Sponsor: Philips Clinical & Medical Affairs Global · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	Tack Endovascular System	Repair of post-PTA dissections using the Intact Vascular Tack Endovascular System

Timeline

• Start date: 2016-06-01
• Primary completion: 2019-05-01
• Completion: 2020-05-01
• First posted: 2016-06-16
• Last updated: 2021-04-05

Locations

17 sites across 4 countries: Austria, Belgium, Germany, Switzerland