Femoropopliteal dissection repair using the Tack Endovascular System (6F, 3.5-6.0mm) following plain balloon angioplasty (POBA) or Lutonix® drug-coated balloon angioplasty


Dissection Resolution


Freedom from Fracture


12m K-M Freedom from CD-TLR


12m Freedom from Implant Migration

79.3 %

12m K-M Primary Patency

0.5 %

Bail Out Stent Rate


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 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.


Scroll to Top
Intact Vascular uses cookies to improve your experience on this website. Some of the cookies we use are essential for parts of the website to operate. Please be aware that if you continue without changing your cookie settings, you consent to this.