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NCT Number: NCT06841510

Efficacy and Safety of GENOSS SES in Patients With Coronary Artery Disease

Efficacy and Safety of GENOSS SES in patients with coronary artery disease

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Coronary Arterial Disease (CAD)

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Bundang Hospital

Seongnam, 13620, South Korea

About this study

GENOSS SES

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 who are contraindicated in the use of heparin, aspirin, clopidogrel, sirolimus, cobalt chromium and contrast agents
  • Patients who are pregnant or planning to become pregnant
  • Patients with a planned surgery to discontinue antiplatelet agents within 12 months
  • Patients with a life expectancy of less than 1 year
  • Patient with cardiogenic shock at the time of hospitalization and had a low chance of survival based on medical judgment.
  • Patients who have already received treatment with another DES (Drug Eluting Stent) or BMS (Bare Metal Stent) at the time of registration
  • Patients participating in randomized controlled trials using other medical devices

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-related 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

    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 50% using any surgical method.

  11. Procedure success

    Time frame: immediately after the procedure

    When the final residual lesion stenosis is less than 50% using any surgical method, and there is no post-procedure death, myocardial infarction, or revascularization during the hospitalization period.

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 GENOSS SES in Patients With Coronary Artery Disease

Acronym: GENOSS SES

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Feb 24, 2025
Registry last updated
Sep 16, 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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