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Active, not recruitingNCT06841510GENOSS SESUpdated Sep 16, 2025

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

An observational study in Coronary Arterial Disease (CAD), sponsored by Genoss Co., Ltd.. Active, not recruiting at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2025-09-16.

Sponsored by Genoss Co., Ltd. · Observational

From the registry’s dates

  • Primary completion was expected by Nov 2025, 10 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
1,118
Ages
19 Years and older
Sex
All
01

Study summary

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

Read the detailed description

GENOSS SES

02

Conditions studied

  • Coronary Arterial Disease (CAD)
03

In context

Lead sponsor

Genoss Co., Ltd. is the lead sponsor of 18 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with coronary artery disease treated with GENOSS SES

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 to the study protocol and clinical follow-up plan, and provide written informed consent as study participants

Exclusion criteria

Exclusion Criteria:

  1. Patients who are contraindicated in the use of heparin, aspirin, clopidogrel, sirolimus, cobalt chromium and contrast agents
  2. Patients who are pregnant or planning to become pregnant
  3. Patients with a planned surgery to discontinue antiplatelet agents within 12 months
  4. Patients with a life expectancy of less than 1 year
  5. Patient with cardiogenic shock at the time of hospitalization and had a low chance of survival based on medical judgment.
  6. Patients who have already received treatment with another DES (Drug Eluting Stent) or BMS (Bare Metal Stent) at the time of registration
  7. Patients participating in randomized controlled trials using other medical devices
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
1,118 participants (actual)
Target follow-up
12 Months
Patient registry
Yes

Groups and cohorts

  • GENOSS Sirolimus Eluting Coronary Stent System

    patients with coronary artery disease treated with GENOSS SES

06

What researchers measure

Primary outcomes

  1. Device-oriented composite endpoint

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

    Time frame: at 12 months after the procedure

Secondary outcomes

  1. Patient-oriented composite endpoint

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

    Time frame: at 12 months after the procedure

  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

    When the final residual lesion stenosis is less than 50% using any surgical method.

    Time frame: during the procedure

  11. Procedure success

    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.

    Time frame: immediately after the procedure

07

Study locations

1 site
  • Seoul National University Bundang Hospital
    Seongnam, 13620, South Korea
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06841510
Lead sponsor
Genoss Co., Ltd.
Responsible party
Sponsor
First posted
Feb 24, 2025
Start date
Apr 19, 2018
Primary completion
Nov 30, 2025 (estimated)
Completion
Nov 30, 2025 (estimated)
Last update
Sep 16, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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Genoss Co., Ltd.

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