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

NCT07158307 | Enrolling By Invitation

• 1 other identifier: CIP-DS1001-3
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease(CAD)

Outcome Measures

Primary Outcomes (1)

• Target lesion failure (TLF)

  composite endpoint of cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization

  at 1 year after the procedure

Secondary Outcomes (6)

• Target lesion failure (TLF)

  at 2, 3 years after the procedure

• Major cardiac adverse events (MACE)

  at 1, 2, 3 years after the procedure

• all mortality

  at 1, 2, 3 years after the procedure

• any MI

  at 1, 2, 3 years after the procedure

• all revascularization and ischemia-driven target lesion revascularization (ID-TLR)

  at 1, 2, 3 years after the procedure

Study Arms (1)

GENOSS® DCB (Paclitaxel-coated PTCA Balloon Catheter)

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

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects who underwent PCI with GENOSS DCB for small coronary artery disease with de novo lesions

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genoss Co., Ltd.: lead

Study Sites (1)

Ulsan University Hospital

Ulsan, 44033, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 5, 2025
• Study Start: June 27, 2024
• Primary Completion (Estimated): June 27, 2030
• Study Completion (Estimated): June 30, 2031
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)