Evaluating a new drug-coated balloon for treating coronary artery disease
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
This study is testing a new drug-coated balloon to see if it can safely and effectively treat people with coronary artery disease who have had previous stents placed.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Seoul National University Hospital Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06104007 on ClinicalTrials.gov |
What this trial studies
This study investigates the long-term safety and efficacy of the Genoss® drug-coated balloon (DCB) catheter, which is designed to treat coronary in-stent restenosis (ISR) following previous stent implantation. The DCB is coated with paclitaxel, shellac, and vitamin E to enhance drug delivery and minimize vascular damage. Participants will undergo percutaneous coronary intervention using this DCB, and their outcomes will be monitored to assess the treatment's effectiveness and safety over time. The study follows a multi-center, observational approach to gather comprehensive data on patient responses.
Who should consider this trial
Good fit: Ideal candidates include patients with coronary in-stent restenosis who are undergoing treatment with the Genoss® DCB.
Not a fit: Patients with a life expectancy of less than one year or those experiencing cardiogenic shock may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the rates of restenosis in patients with coronary artery disease.
How similar studies have performed: Previous studies have shown that drug-coated balloon therapy is safe and effective, indicating a promising outlook for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Seoul
- Bon-Kwon Koo — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Bon-Kwon Koo, MD, PhD
- Email: bkkoo@snu.ac.kr
- Phone: +82-2-2072-2062
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.