Status:
ENROLLING_BY_INVITATION
Safety and Efficacy of GENOSS® DCB With a Shellac Plus Vitamin E Excipient in Patients With De Novo Lesion
Lead Sponsor:
Genoss Co., Ltd.
Conditions:
Coronary Artery Disease(CAD)
Eligibility:
All Genders
19+ years
Brief Summary
The GENOSS PCB-De Novo 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 De no...
Detailed Description
This prospective, open-label, multicenter, observational study will enroll patients with de novo small coronary artery disease undergoing PCI with the GENOSS® DCB at 47 hospitals. Because this is an ...
Eligibility Criteria
Inclusion
- Adults over the age of 19
- Patients with new lesions with coronary small vascular disease (vascular diameter \<3.0 mm) underwent a GENOSS® DCB procedure through percutaneous coronary intervention
- Subjects who agreed to the clinical research plan and the clinical follow-up plan, voluntarily decided to participate in this clinical study, and agreed in writing to the consent of the study subjects
Exclusion
- Subjects who plan to become pregnant during the period of this study as women of the gestational age
- Subjects whose remaining life expectancy is expected to be less than one year
- Subjects who visited the hospital due to psychogenic shock at the time of visiting the hospital and are predicted to have a low chance of survival based on medical judgment
- If it falls under any of the following items after prior dilation of the target lesion;
- Stent procedures are required due to vascular detachment that limits blood flow
- If the residual stenosis is \>30%
- If the TIMI flow is \<3
- Subjects participating in a randomized study of medical devices
- If the researcher determines that it is not appropriate for this clinical study or may increase the risk associated with participation in the study
Key Trial Info
Start Date :
June 27 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2031
Estimated Enrollment :
3000 Patients enrolled
Trial Details
Trial ID
NCT07158307
Start Date
June 27 2024
End Date
June 30 2031
Last Update
September 5 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Ulsan University Hospital
Ulsan, South Korea, 44033