NCT02942966

Tack Optimized Balloon Angioplasty Study of the Tack Endovascular System® in Below the Knee Arteries

Tack Optimized Balloon Angioplasty Study for the Below The Knee Arteries Using the Tack Endovascular System®

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 233 (actual)
• Sponsor: Philips Clinical & Medical Affairs Global · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multi-center, single-arm, non-blinded study designed to investigate the safety and efficacy of the Tack Endovascular System in the Mid/Distal Popliteal, Tibial, and Peroneal Arteries ranging in diameter from 1.5mm to 4.5mm for the treatment of post percutaneous transluminal balloon angioplasty (PTA) dissection(s) requiring repair.

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: 2017-02-08
• Primary completion: 2019-07-11
• Completion: 2022-01-10
• First posted: 2016-10-24
• Last updated: 2022-01-31
• Results posted: 2021-07-28

Locations

49 sites across 6 countries: United States, Austria, Czechia, Germany, Hungary, New Zealand

Regulatory

• FDA-regulated device study