Status:
RECRUITING
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
Lead Sponsor:
Seoul National University Hospital
Conditions:
Coronary Artery Disease
In-stent Restenosis
Eligibility:
All Genders
19+ years
Brief 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-s...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 17 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT06104007
Start Date
August 17 2023
End Date
December 31 2028
Last Update
October 27 2023
Active Locations (1)
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1
Bon-Kwon Koo
Seoul, South Korea