Efficacy and Safety of 1-year Duration of DAPT After GENOSS® DES Implantation in Patients with Coronary Artery Disease According to the Complex Higher-risk Procedure

Last updated: February 18, 2025
Sponsor: Genoss Co., Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Coronary Artery Disease

Open Heart Surgery

Heart Disease

Treatment

Genoss DES™ stent

Genoss DES stent

Clinical Study ID

NCT06075433
CIP-DS0501-14
  • Ages > 19
  • All Genders

Study Summary

The objective of study is to evaluate the efficacy and safety of 1 year duration of DAPT after GENOSS® DES Implantation in patients with coronary artery disease according to the complex higher-risk (and indicated) procedure.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients of 19 and over

  2. Patients with coronary artery disease treated with GENOSS SES

  3. Participants who voluntarily decide to participate in this clinical trial, agree tothe study protocol and clinical follow-up plan, and provide written informed consentas study participants

Exclusion

Exclusion Criteria:

  1. Patients with cardiogenic shock at the time of hospitalization

  2. Patients who are pregnant or planning to become pregnant

  3. Patients with a life expectancy of less than 1 year

  4. Patients participating in randomized controlled trials using other medical devices

  5. Patients who have already received treatment with another DES (Drug Eluting Stent)or BMS (Bare Metal Stent) at the time of registration (However, other stentinsertions are allowed due to failure of GENOSS DES insertion)

Study Design

Total Participants: 1000
Treatment Group(s): 2
Primary Treatment: Genoss DES™ stent
Phase:
Study Start date:
May 13, 2022
Estimated Completion Date:
December 31, 2027

Study Description

The Genoss DES is a novel, biodegradable, polymer-coated, sirolimus eluting stent with a cobalt-chromium stent platform and thin strut. Although the efficacy and safety of this stent have been previously investigated, real-world clinical outcomes data are lacking. Therefore, the objective of this prospective, multicenter study was to evaluate the clinical efficacy and safety of 1 year duration of DAPT after GENOSS® DES Implantation in patients with coronary artery disease according to the complex higher-risk (and indicated) procedure.

The Genoss DES registry is a prospective, single-arm, observational study for evaluation of clinical outcomes of 1 year duration of DAPT after Genoss DES implantation in patients with coronary artery disease according to the complex higher-risk (and indicated) procedure from 9 sites in South Korea. The primary endpoint was a deviceoriented composite endpoint (DOCE), defined as a composite of cardiac death, target vessel-related myocardial infarction (MI), and clinically indicated target lesion revascularization (TLR) at 12 months. The key secondary endpoint was a patient-oriented composite endpoint (POCE), defined as a composite of all-cause death, any myocardial infarction, and any revascularization at 12 months.

Connect with a study center

  • Wonju Severance Christian Hospital

    Wŏnju, Gangwon state
    Korea, Republic of

    Active - Recruiting

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