Author + information
- Ariel Furer1,
- Pawel Gasior2,
- Jenn McGregor3,
- Taylor Palmieri4,
- Gerard Conditt5,
- Juan Granada6 and
- Greg Kaluza7
- 1CRF, new york, New York, United States
- 2CRF Skirball Center for Innovation, Fort Lee, New Jersey, United States
- 3Cardiovascular Research Foundation, Orangeburg, New York, United States
- 4Cardiovascular Research Foundation, Orangeburg, New York, United States
- 5CRF-Skirball Center for Innovation, Nyack, New York, United States
- 6CRF Skirball Center for Innovation, Orangeburg, New York, United States
- 7CRF Skirball Center for Innovation, Orangeburg, New York, United States
Renal artery stenting for Atherosclerotic renovascular disease (ARVD) has been a subject of debate for the last two decades. A subset of patients with severe ARVD and large renal mass involvement, who were misrepresented in latest large clinical trials, could gain benefit from this strategy. This is the first feasibility and safety evaluation of bioresorbable scaffolds implanted in healthy porcine renal arteries.
Twelve renal arteries of 8 Yucatan miniswine received Melange Bioresorbable Scaffold (BRS, Meril Life Sciences, India) with a diameter of 5 mm (n=7) and 6 mm (n=5). Scaffolds were overexpanded to achieve 1.2:1 scaffold/vessel ratio. Follow up angiography and optical coherence tomography (OCT) were performed at 30 (n=10) and 90 days (n=12).
Mean acute recoil was 3±5% (0.16 ± 0.26 mm). At 30 days, late recoil was -2±12% (-0.23 ± 2.07 mm2), % Area stenosis (AS) was 7±2 % and neointimal area 15±0.26 mm2. Angiography showed % diameter stenosis (%DS) 7±5% with late loss of 0.28±0.32mm2. 90 days recoil was -11±20% (-1.50±2.97 mm2), % AS was 11±5% and neointimal area 1.95±1.06 mm2. On angiography at 90 days %DS was 10±4% with late loss of 0.37±0.25 mm2 (n=9). No peri-procedural or device related complications were observed.
Large diameter BRS implantation in porcine renal arteries model appears to be safe and feasible. Early follow up results showed promising angiographic and OCT results at 90 days. Further validation of this technology is needed in order to assess its true clinical potential.
OTHER: Pre-Clinical/First In-Human Studies