This prospective, single-arm study evaluated patients with peripheral arterial disease (Rutherford clinical category 2-4) caused by lesions of the superficial femoral and popliteal arteries. Patients were treated with standard, non drug-coated balloon angioplasty, and post-PTA dissections were treated with Tack placement.
The primary end points were core laboratory-adjudicated device technical success* and device safety**. Patients were followed up to twelve months after implantation.
- Tack implants were used in 130 patients with post-PTA dissections (74.0% ≥ grade C***)
- Absence of new-onset MAEs was achieved in 100% of patients at 30 days
- Technical success was achieved in 98.5% of patients
- K-M twelve-month patency: 76.4%
- Freedom from CD-TLR: 89.5%
Significant improvement from baseline was observed in Rutherford clinical category (82.8% with RCC 1 at 12-m) and ankle-brachial index (0.68± 0.18 to 0.94 ± 0.15; P < .0001).
- Tack implant treatment of post-PTA dissection was safe, produced reasonable patency, and resulted in low rates of target lesion revascularization
These twelve-month results were presented at LINC 2015 by Dr. Marc Bosiers and published in the Journal of Vascular Surgery.Read Press Release
Additional twenty-four month follow-up data from Westküstenkliniken in Heide, Germany was analyzed and presented at the 2017 VEITHsymposium™ by Dr. Christian Wisgott.Read Press Release
Single-center twenty-four month results:
- K-M six-month patency: 93.8%
- K-M twelve-month patency: 87.5%
- K-M twenty-four month patency: 87.5%
- No loss of patency from twelve to twenty-four months
*defined as the ability of the Tack implants to resolve post-PTA dissection, which was achieved when the dissection was no longer visible by angiography and acute arterial patency was maintained at the implant location
**composite of all new-onset major adverse events (MAEs), which were defined as device and arterial embolization, need for emergency surgical revascularization, amputation above the ankle, or clinically driven TLR through 30 days after the procedure.
***arterial dissections were classified using the NHLBI grading system and adjudicated by the core laboratory.