Author + information
- Alexandre Abizaid1,
- Mathias Vrolix2,
- J. Ribamar Costa Jr.3,
- Daniel Chamie1,
- Andrea Abizaid1,
- Juliana Castro4,
- Vinayak Bhat5,
- Lynn Morrison6,
- Sara Toyloy5 and
- Stefan Verheye7
- 1Instituto Dante Pazzanese de Cardiologia, São Paulo, São Paulo, Brazil
- 2St Jan Zikenhuis ZOL, Genk, Belgium
- 3Instituto Dante Pazzanese, Sao Paulo, São Paulo, Brazil
- 4CRC, São Paulo, São Paulo, Brazil
- 5Elixir Medical Corporation, Milpitas, California, United States
- 6Elixir Medical, sunnyvale, California, United States
- 7Cardiovascular Center ZNA Middelheim, Antwerp, Belgium
The DESolve Cx study is a prospective, multi-center evaluation of the safety and efficacy of the DESolve® Cx Novolimus-Eluting Bioresorbable Coronary Scaffold System (BCSS) using clinical endpoints and multiple imaging modalities.
The DESolve Cx BCSS is a novel, thin strut (120 μm) drug eluting bioresorbable vascular scaffold (BRS) that combines a poly-L-lactide-based (PLLA-based) scaffold coated with a biodegradable PLLA-based polymer and the drug Novolimus (5 μg per mm of scaffold length), a macrocyclic lactone mTOR inhibitor. The DESolve Cx scaffold differentiates itself from other BRS with thin struts minimizing areas of flow disturbance, and 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]. DESolve Cx scaffold also offers high expansion capacity without strut fracture. A total of 50 patients with single, de novo coronary artery lesions were enrolled in this prospective, multi-center, single-arm registry. Those patients receiving the study device are being analysed for multiple clinical endpoints including: Major Adverse Cardiac Events (MACE), a composite endpoint of cardiac death, target vessel MI, or clinically-indicated target lesion revascularization (CI-TLR); Device and Procedure Success; Clinically-indicated Target Lesion and Target Vessel Revascularization, (CI-TVR) and Stent Thrombosis assessed at 1, 6 and 12 months and annually to 3 years.
Baseline subject characteristics included 68% male, 60.0 ± 10.3 years of age, 20% presented with diabetes mellitus, 26% were current smokers, 84% and 70% had hypercholesterolemia and hypertension respectively. There were no MACE events reported at 6 months. Angiographic late lumen loss was low at 0.19 ± 0.25. All patients Clinical and multimodality imaging results through 12 month will be presented.
The 120 μm DESolve® Cx Novolimus-Eluting BCSS offers unique characteristics and has demonstrated safety and efficacy in this study through 6 months. A report of the 12-month clinical and full multimodality imaging results will be presented.
CORONARY: Stents: Bioresorbable Vascular Scaffolds