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

Recruiting Observational Study
Coronary Artery Disease In-stent Restenosis
No Placebo Group Every participant receives an active treatment — no one gets a placebo. No Study Drug Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
19 and older
Sex
Any
Study type
Observational
Participants needed
1,000 (estimated)
Sponsor
Seoul National University Hospital · Other
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About This Trial

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).

Trial Locations
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Eligibility Criteria
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 res…
Contacts

Bon-Kwon Koo, MD, PhD

+82-2-2072-2062

bkkoo@snu.ac.kr

CONTACT