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

Summary

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).

Eligibility

Inclusion Criteria:

* Patients with coronary in-stent restenosis (ISR) who underwent percutaneous coronary intervention using the Genoss® DCB.
* Participants who have agreed to the clinical trial protocol and the clinical follow-up study plan, voluntarily decided to participate in this clinical research, and have provided written consent on the research participant agreement form.

Exclusion Criteria:

* Women of childbearing age who plan to become pregnant during the study duration.
* Patients scheduled for a surgery within 12 months of enrollment that requires discontinuation of antiplatelet agents.
* Patients for whom the expected remaining life span is less than one year.
* Patients who presented with cardiogenic shock at the time of their visit and, based on medical assessment, are predicted to have a low likelihood of survival.
* Patients currently involved in a randomized medical device study.
* Patients deemed by the researcher to be unsuitable for this study or whose participation might increase associated risks.

Conditions3

Browse More Trials