Safety and Efficacy of Paclitaxel Coated PTCA Balloon Catheter With a Shellac Plus Vitamin E Excipient (GENOSS® DCB) in Patients With Coronary In-stent Restenosis (ISR): A Prospective, Multi-center, Observational Study

Overview

The SFRGENISTA study aims to evaluate the long-term efficacy and safety of a paclitaxel-coated balloon catheter containing shellac and vitamin E excipients (Genoss® DCB) in patients with coronary in-stent restenosis (ISR).

Drug-coated balloon (DCB) treatment is a therapeutic strategy to overcome in-stent restenosis (ISR) that occurs after drug-eluting stent (DES) implantation. The 2018 European guidelines on myocardial revascularization recommend DCB treatment in patients with bare-metal stent (BMS) or DES ISR lesions. The Sequent Please World Wide Registry has shown that DCB therapy is safe and exhibits a low target lesion revascularization (TLR) rate in a large population. The Genoss® DCB is coated with 3µg/mm² of paclitaxel along with shellac, a hydrophilic excipient for rapid release and diffusion into the tissue. Additionally, it incorporates vitamin E, an antioxidant known to directly prevent the accumulation of smooth muscle cells associated with neointimal hyperplasia that arises from the vessel wall being damaged by the balloon catheter. The catheter was designed to enhance trackability and pushability, minimize vascular damage with the application of a hydrophilic coating to the distal part, and use a soft yet durable end-tip for easier access to the target lesion. In a clinical trial comparing Genoss® DCB to the Sequent® Please (B-BRAUN) DCB, the in-segment late lumen loss at six months after DCB was comparable, and the rates of adverse clinical events were similar. Given this background, this study intends to investigate the long-term efficacy and safety of the Genoss® DCB in patients with coronary ISR.

Conditions