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Coronary Arterial Disease (CAD)GENOSS SESNCT06841510

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

An observational study of Coronary Arterial Disease (CAD), run by Genoss Co., Ltd. at 1 site in South Korea.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Efficacy and Safety of GENOSS SES in patients with coronary artery disease Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Coronary Arterial Disease (CAD)
How many people
1,118 participants
Where
1 siteSouth Korea
Study dates
19 Apr 2018to 30 Nov 2025
How long will I take part?
12 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with coronary artery disease treated with GENOSS SES

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Bundang Hospital

    Seongnam, 13620

Other trials in South Korea

About this study

Official title: A Prospective, Multicenter, Observational Study to Evaluate the Efficacy and Safety of GENOSS SES in Patients With Coronary Artery Disease

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

Read the detailed description

GENOSS SES

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06841510
Study groupRoleWhat they receive
GENOSS Sirolimus Eluting Coronary Stent Systempatients with coronary artery disease treated with GENOSS SES

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: at 12 months after the procedure

Secondary outcomes (11)

  1. Patient-oriented composite endpoint

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

    Measured: at 12 months after the procedure

  2. All-cause deaths

    Measured: at 12 months after the procedure

  3. Cardiac death

    Measured: at 12 months after the procedure

  4. Non-cardiac death

    Measured: at 12 months after the procedure

  5. Any myocardial infarction

    Measured: at 12 months after the procedure

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

    Measured: at 12 months after the procedure

  7. Any revascularization

    Measured: at 12 months after the procedure

  8. Clinically indicated target lesion revascularization (TLR)

    Measured: at 12 months after the procedure

  9. Stent thrombosis

    Measured: at 12 months after the procedure

  10. Lesion success

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

    Measured: 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.

    Measured: immediately after the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2025
  2. Study start19 Apr 2018
  3. Primary completion30 Nov 2025 (estimated)
  4. Study completion30 Nov 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
1,118 participants (actual)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06841510
Sponsor's protocol ID
CIP-DS0501-09
Acronym
GENOSS SES
Status last verified
Feb 2025
First submitted
17 Feb 2025
Last updated
16 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Arterial Disease (CAD), run by Genoss Co., Ltd. at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Device-oriented composite endpoint (time frame: at 12 months after the procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06841510.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.

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