Author + information
- Andrew Holden1,
- Kenneth Ouriel2,
- Michael Jaff3,
- Vinayak Bhat4,
- Stephanie Simpson-Plaumann5 and
- Sara Toyloy4
Bioresorbable scaffolds may address limitations of drug-eluting balloons and stents for superficial femoral artery (SFA) atherosclerotic disease by: preventing acute recoil, reducing restenosis; and allowing area retreatment made difficult with stents. The Akesys Prava is a balloon expandable poly L-lactide-based polymer scaffold incorporating the drug sirolimus (rapamycin) available in 5mm and 6mm diameters and 18 and 57mm lengths. The scaffold is loaded with approximately 17μg sirolimus per mm of scaffold length, elutes approximately 30% of the drug over 4 weeks with a shorter bioresorption time [>90% reduction in molecular weight within 6 months with near complete bioresorption by 1 year (∼70% mass loss) in preclinical studies].
The DESappear Study is a multicenter, prospective, single-arm, safety and performance evaluation of the Akesys Prava Sirolimus Eluting Bioresorbable Peripheral Scaffold System for the treatment of de novo SFA lesions through clinical and imaging endpoints. Key inclusion criteria are symptomatic claudication (Rutherford 2-4), vessel diameter ≥ 5.0 mm to ≤ 6.0mm, lesion length ≤ 53 mm and target lesion ≥ 50% DS. Subjects will undergo clinical and duplex ultrasound (DUS) follow-up assessments at 1, 6 and 12 months and annually up to 3 years. The primary safety endpoint is the composite of freedom from perioperative death through 30 days and freedom from major adverse limb events, or major open surgical revascularization through 6 months. The primary effectiveness endpoint is primary patency defined as freedom from restenosis using DUS or clinically-driven target lesion revascularization through 6 months. An imaging cohort of 10-15 subjects will undergo angiographic and optical coherence tomography (OCT) imaging following scaffold deployment and repeat angiography with OCT at 6 months.
The study is currently enrolling and will include up to 60 patients in Europe and New Zealand.
The DESappear study will evaluate the safety and performance of the Akesys Prava scaffold. Acute and long-term data will be presented for enrolled patients.
ENDOVASCULAR: Peripheral Vascular Disease and Intervention