Actively Recruiting
Safety and Efficacy of Paclitaxel Coated PTCA Balloon Catheter With a Shellac Plus Vitamin E Excipient (GENOSS AE 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
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research focuses on patients with coronary in-stent restenosis (ISR), a condition where narrowing occurs inside a previously placed stent in the coronary arteries. The study evaluates the long-term effects of a paclitaxel-coated balloon catheter named Genoss AE DCB, which contains shellac and vitamin E to support drug delivery and reduce vessel damage. The trial aims to understand how well this device works and its safety in treating ISR patients. Participants receive treatment with the Genoss AE DCB during percutaneous coronary intervention (PCI), a procedure to open narrowed arteries. The catheter is designed with a hydrophilic coating and a soft tip to improve ease of use and minimize vessel injury. The choice to use this device depends on each patient's condition and the specific characteristics of the lesions seen on angiography. This is an observational study where patients who have already undergone PCI with the Genoss AE DCB are followed over time. During the study, participants will be monitored for up to one year to evaluate outcomes such as target lesion failure and major cardiac events, including heart attacks, deaths, revascularizations, bleeding, strokes, and stent thrombosis. Researchers will collect clinical follow-up data to assess safety and effectiveness. The study involves regular medical evaluations to track participants' health and responses to the treatment over this period.
CONDITIONS
Brief 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 Genoss�AE 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure day
Participants undergo percutaneous coronary intervention using the Genoss® drug-coated balloon catheter according to standard treatment protocols.
1 visit (in-person)
Duration - 1 year
Participants are monitored for safety and efficacy outcomes including cardiac events and revascularization over one year following the intervention.
Approximately 3 to 4 follow-up visits over 1 year
Trial Site Locations
Total: 1 location
1
Bon-Kwon Koo
Seoul, South Korea
Actively Recruiting
Research Team
B
Bon-Kwon Koo, MD, PhD
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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