Safety and Efficacy of GENOSS® DCB With a Shellac Plus Vitamin E Excipient in Patients With De Novo Lesion

• Conditions: Coronary Artery Disease(CAD)

• Registration Number: NCT07158307
• Lead Sponsor: Genoss Co., Ltd.

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 novo small coronary artery disease.

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 observational study, the number of participants will not be calculated separately, but a total of 3,000 participants are planned to be recruited during the study enrollment period.

All patients will be followed up at 1, 2, and 3 years postprocedure to evaluate the safety and efficacy of the paclitaxel-coated PTCA balloon catheter.

Study Timeline

• Study Start: 2024-06-27
• Status Verified: 2025-08
• Study First Submitted: 2025-08-28
• Study First Submitted QC: 2025-08-28
• Last Update Submitted: 2025-08-28
• Study First Posted: 2025-09-05
• Last Update Posted: 2025-09-05
• Primary Completion: 2030-06-27
• Study Completion: 2031-06-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Target lesion failure (TLF)	at 1 year after the procedure	composite endpoint of cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization

Secondary Outcome Measures

Name	Time	Method
Target lesion failure (TLF)	at 2, 3 years after the procedure	composite endpoint of cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization
Major cardiac adverse events (MACE)	at 1, 2, 3 years after the procedure	composite endpoint of death, myocardial infarction, and revascularization
all mortality	at 1, 2, 3 years after the procedure	all deaths and cardiac deaths
any MI	at 1, 2, 3 years after the procedure	all myocardial infarction and target vessel myocardial infarction (TV-MI)
all revascularization and ischemia-driven target lesion revascularization (ID-TLR)	at 1, 2, 3 years after the procedure
major bleeding event	at 1, 2, 3 years after the procedure	BARC 3, 5

Trial Locations

Locations (1)

Ulsan University Hospital; 🇰🇷 Ulsan, South Korea