Pre-clinical data suggest that the Tack device causes minimal vessel injury.
Early clinical experience (pre-clinical study and first-in-human) provided preliminary data on the safety and feasibility of the use of Tack implants for managing post-PTA dissection
• Reduction in % diameter stenosis with the Tack
(16.8 ± 2.6%) compared with stents (46.4 ± 9.8%)
• Neointimal thickness and injury scores decreased
with Tack implantation
• Acute technical success* with resolution of the post-
PTA dissection in 100% of lesions
• No device related complications
• No major amputations
• Twelve-month angiographic patency** was 83.3%
* Technical success was defined as acute luminal patency at the conclusion of the revascularization procedure, with angiography demonstrating that the lumen of the artery at the location of implant remains patent.
**Restenosis was defined as ≥50% by angiography.
Clinical use of the Tack device to manage post-PTA dissection was safe and feasible in this early study and resulted in apposition of dissection flaps without stent placement.
DESCRIPTION: In the pre-clinical study, seven swine underwent superficial femoral artery stent and Tack implantation for microscopy at 28 days. The first-in-man clinical study evaluated the safety and feasibility using the Tack Endovascular System® in patients with vascular flaps in the infrainguinal arteries following angioplasty dissection. The study included 15 limbs that underwent revascularization for critical limb ischemia or claudication. Patients were followed up to twelve months after implantation.
The data demonstrated that they system was safe, and were published in the Journal of the American College of Cardiology: Cardiovascular Interventions.
To learn more about this study, visit www.clinicaltrials.gov and search for NCT02044003.