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NCT Number: NCT06075420

Efficacy and Safety of Short Duration of DAPT After GENOSS® DES Implantation in Patients with Coronary Artery Disease

The objective of study is to evaluate the efficacy and safety of short duration of DAPT after GENOSS® DES Implantation in patients with coronary artery disease.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Wonju Severance Christian Hospital

Wŏnju, Gangwon State, South Korea

Location status: Recruiting

Location contact

Young Jin Youn

CONTACT

[email protected]

033-741-0910

About this study

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 short duration of DAPT after GENOSS® DES Implantation in patients with coronary artery disease.

The Genoss DES registry is a prospective, single-arm, observational study for evaluation of clinical outcomes of short duration of DAPT (3 months for SCAD, 6 months for ACS) after Genoss DES implantation in patients with coronary artery disease from 6 sites in South Korea. The primary endpoint was a device-oriented 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients of 19 and over
  • Patients with coronary artery disease treated with GENOSS SES
  • Participants who voluntarily decide to participate in this clinical trial, agree to the study protocol and clinical follow-up plan, and provide written informed consent as study participants

Exclusion criteria

  • Patients with cardiogenic shock at the time of hospitalization
  • Patients who are pregnant or planning to become pregnant
  • Patients with a life expectancy of less than 1 year
  • Patients participating in randomized controlled trials using other medical devices
  • Patients who have already received treatment with another DES (Drug Eluting Stent) or BMS (Bare Metal Stent) at the time of registration (However, other stent insertions are allowed due to failure of GENOSS DES insertion)

Treatment and study plan

Primary outcomes

  1. Device-oriented composite endpoint

    Time frame: at 12 months after the procedure

    DOCE is defined as a composite of cardiac death, target vessel-related myocardial infarction (TV-MI) and clinically indicated target-lesion revascularization (TLR).

Secondary outcomes

  1. Patient-oriented composite endpoint

    Time frame: at 12 months after the procedure

    POCE is defined as a composite of all-cause death, any myocardial infarction, and any revascularization.

  2. All-cause deaths

    Time frame: at 12 months after the procedure

  3. Cardiac death

    Time frame: at 12 months after the procedure

  4. Non-cardiac death

    Time frame: at 12 months after the procedure

  5. Any myocardial infarction

    Time frame: at 12 months after the procedure

  6. Target vessel-realted myocardial infarction (TV-MI)

    Time frame: at 12 months after the procedure

  7. Any revascularization

    Time frame: at 12 months after the procedure

  8. Clinically indicated target lesion revascularization (TLR)

    Time frame: at 12 months after the procedure

  9. Stent thrombosis by ARC definition

    Time frame: at 12 months after the procedure

  10. Lesion success

    Time frame: during the procedure

    When the final residual lesion stenosis is less than 30% using any surgical method.

  11. Procedure success

    Time frame: immediately after the procedure

    When the final residual lesion stenosis is less than 30% using any surgical method, and there is no post-procedure death, myocardial infarction, or revascularization during the hospitalization period

Study contacts

Contact information is provided by the study sponsor or research team.

YoungJin Youn

CONTACT

[email protected]

033-741-0910

Sponsors and collaborators

Lead sponsor

Genoss Co., Ltd.

Industry

Registry information

Official study title

A Prospective, Multicenter, Observational Study to Evaluate the Efficacy and Safety of Short Duration of DAPT After GENOSS® DES Implantation in Patients with Coronary Artery Disease

Acronym: DAPTShort

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Oct 10, 2023
Registry last updated
Feb 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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