NCT06104007 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
| NCT ID | NCT06104007 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Seoul National University Hospital |
| Condition | Coronary Artery Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2023-08-17 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2023-08-17 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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-stent restenosis (ISR).
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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06104007 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06104007 currently recruiting?
Yes, NCT06104007 is actively recruiting participants. Contact the research team at bkkoo@snu.ac.kr for enrollment information.
Where is the NCT06104007 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT06104007 clinical trial?
NCT06104007 is sponsored by Seoul National University Hospital. The trial plans to enroll 1,000 participants.