Ireland
--:--IST
Enrolling by invitation Observational

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

NCT07158307 · tracked via the Priya Life Science South Korea tracker
Phase
Observational
Started
2024-06-27
Last updated
2025-09-05

Condition(s) studied

Coronary Artery Disease(CAD)

Study 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.

Eligibility

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
Ulsan University Hospital Ulsan South Korea
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07158307 on ClinicalTrials.gov ↗ ← All trials in South Korea