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 or Lutonix® drug-coated balloon angioplasty (physician discretion), and post-PTA dissections were treated with Tack placement.
The primary end points* were freedom from MAE and primary patency.
- Safety: No MAE at 30 days
- 79.3% 12-month primary patency
- 86.5% 12-month freedom from CD-TLR
- 92.1% of dissections were completely resolved (69.4% of patients had a dissection ≥ Grade C)
- Improvement in ABI, Rutherford Classification and Quality of Life measures
There were no fractures reported, and only one bailout stent was placed.
High patency rate (79.3%) and high freedom from CD-TLR (86.5%) position Tack to be a clinically important treatment option for focal dissection repair after balloon angioplasty.
Twelve-month results were presented at VIVA 2018 by Dr. William Gray and manuscript is pending publication.
Safety: Freedom from the occurrence of any new onset major adverse event(s) (MAEs) defined as index limb amputation (above the ankle), CEC adjudicated clinically-driven target lesion revascularization (CD-TLR), or all-cause death at 30 days
Efficacy: Primary patency defined as freedom from CEC adjudicated clinically-driven target lesion revascularization (CD-TLR) and freedom from core lab adjudicated duplex ultrasound derived binary restenosis at 12 months (defined as PSVR >2.5)
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