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

NCT ID: NCT07158307

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 3000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-27
• Study Completion Date: 2031-06-30

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.

Conditions

Coronary Artery Disease(CAD)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

GENOSS® DCB (Paclitaxel-coated PTCA Balloon Catheter)

Patients with de novo small coronary artery disease who underwent PCI with GENOSS DCB

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genoss Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ulsan University Hospital

Ulsan, , South Korea

Countries

South Korea

Other Identifiers

CIP-DS1001-3

Identifier Type: -

Identifier Source: org_study_id