PURPOSE–BUILT. PRECISION REPAIR. PRESERVES OPTIONS.
Femoropopliteal dissection repair using the Tack Endovascular System (6F, 3.5-6.0mm) following IN.PACT™ Admiral™ drug-coated balloon angioplasty
97.7%
Dissection Resolution
97.5%
12m K-M Freedom
from CD-TLR
95.0%
12m K-M Primary Patency
0.6%
Bail Out Stent Rate
Conclusion:
High patency rate and high freedom from CD-TLR position Tack to be a clinically important treatment option for focal dissection repair after balloon angioplasty.
STATUS: In follow up, enrollment complete (N=201). 169 patients with lesions ≤150mm and 32 patients with lesions >150mm and ≤250mm.
DESCRIPTION: This multi-center, single-arm European study is designed to investigate the safety and efficacy of the Tack Endovascular System® for the repair of dissection(s) type(s) A through F resulting from post percutaneous transluminal angioplasty (PTA) using the Medtronic IN.PACT™ Admiral™ drug-coated angioplasty balloon in the superficial femoral and proximal popliteal arteries. 169 patients were enrolled with lesions ≤150mm and powered to meet primary endpoints (key results above). An additional 32 patients with lesions >150 and ≤250mm were enrolled and analyzed separately for observation:
• 98.8 Dissection resolution
• 89.3% K-M Patency at 12 months
• 96.8% K-M Freedom from CD-TLR at 12 months
• 0.0% Bail out stent rate
There were a total of 201 patients enrolled at 14 European sites and twelve-month follow up has been completed. This study is in the follow-up phase.
Twelve-month results were presented in San Francisco, California at the TCT 2019 Conference by Dr. Marianne Brodmann.
To learn more about this study, visit www.clinicaltrials.gov and search for NCT02802306.
IN.PACT™ and Admiral™ are trademarks of Medtronic, Inc.