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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

Recruitingn/aAges 19 Years - anyAllSeoul National University Hospital
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • Genoss® DCB
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Where

1 site
Bon-Kwon Koo
Seoul, South Korea
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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