Long-Term Safety and Effectiveness of Genoss4 DCB Balloon Catheter for Coronary In-Stent Restenosis in Adults A Multi-Center Observational Study

What this Trial Is About

This research focuses on patients with coronary in-stent restenosis ISR, a condition where narrowing occurs inside a previously placed stent in the coronary arteries. The study evaluates the long-term effects of a paclitaxel-coated balloon catheter named GenossAE DCB, which contains shellac and vitamin E to support drug delivery and reduce vessel damage. The trial aims to understand how well this device works and its safety in treating ISR patients. Participants receive treatment with the GenossAE DCB during percutaneous coronary intervention PCI, a procedure to open narrowed arteries. The catheter is designed with a hydrophilic coating and a soft tip to improve ease of use and minimize vessel injury. The choice to use this device depends on each patients condition and the specific characteristics of the lesions seen on angiography. This is an observational study where patients who have already undergone PCI with the GenossAE DCB are followed over time. During the study, participants will be monitored for up to one year to evaluate outcomes such as target lesion failure and major cardiac events, including heart attacks, deaths, revascularizations, bleeding, strokes, and stent thrombosis. Researchers will collect clinical follow-up data to assess safety and effectiveness. The study involves regular medical evaluations to track participants health and responses to the treatment over this period.

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