Actively 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
Led by Seoul National University Hospital · Updated on 2023-10-27
1000
Participants Needed
1
Research Sites
280 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with coronary in-stent restenosis (ISR) who underwent percutaneous coronary intervention using the Genoss4 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.
You will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Bon-Kwon Koo
Seoul, South Korea
Actively Recruiting
Research Team
B
Bon-Kwon Koo, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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