Evaluating a new drug-coated balloon for treating coronary artery disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.