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Enrolling by invitation NCT07158307

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

— Observational Coronary Artery Disease(CAD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Coronary Artery Disease(CAD). Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Safety and Efficacy of Paclitaxel-coated PTCA Balloon Catheter With a Shellac Plus Vitamin E Excipient (GENOSS® DCB) in Patients With De Novo Lesion of Small Coronary Artery Disease: A Prospective, Multi-center, Observational Study

Overview

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.

Primary outcome measures

  • Target lesion failure (TLF) [Time frame: at 1 year after the procedure]
Secondary outcome measures (6)
  • Target lesion failure (TLF) [Time frame: at 2, 3 years after the procedure]
  • Major cardiac adverse events (MACE) [Time frame: at 1, 2, 3 years after the procedure]
  • all mortality [Time frame: at 1, 2, 3 years after the procedure]
  • any MI [Time frame: at 1, 2, 3 years after the procedure]
  • all revascularization and ischemia-driven target lesion revascularization (ID-TLR) [Time frame: at 1, 2, 3 years after the procedure]
  • major bleeding event [Time frame: at 1, 2, 3 years after the procedure]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

South Korea · 1 center
  • Ulsan University Hospital — Ulsan

Identifiers

NCT: NCT07158307 · CIP-DS1001-3

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗