PURPOSE–BUILT. PRECISION REPAIR. PRESERVES OPTIONS.
Femoropopliteal dissection repair using the Tack Endovascular System (6F, 3.5-6.0mm) following plain balloon angioplasty (POBA) or Lutonix® drug-coated balloon angioplasty
92.1%
Dissection Resolution
100%
Freedom from Fracture
86.5%
12m K-M Freedom from CD-TLR
99.9%
12m Freedom from Implant Migration
79.3 %
12m K-M Primary Patency
0.5 %
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: This study has met its primary endpoints, and patients are in follow-up phase.
DESCRIPTION: This multi-center, U.S. and European study is designed to evaluate the safety and effectiveness of the Tack Endovascular System® for the repair of dissection(s) type(s) A through F resulting from percutaneous transluminal balloon angioplasty (PTA) using standard and drug-coated balloon angioplasty (BARD Lutonix®) in the superficial femoral and proximal popliteal arteries.
This study received FDA IDE approval in August 2015 and subject enrollment is complete. There were 213 patients enrolled at 33 United States and European sites and twenty-four-month follow up has been completed. This study is in the follow-up phase. To learn more about this study, visit www.clinicaltrials.gov and search for NCT02522884.
Twelve-month results were presented in Las Vegas, Nevada at the VIVA 2018 Conference by Dr. William Gray and published in JACC: Cardiovascular Intervention
Lutonix® is a registered trademark of BD Interventional.