AzTrials
AzTrials

Acute Coronary SyndromeGENOSS ACSNCT06075368

Efficacy and Safety of GENOSS® SES in Patients With Acute Coronary Syndrome (GENOSS ACS)

An observational study of Acute Coronary Syndrome and Percutaneous Coronary Intervention, 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
Search all trials

Trial summary

The objective of this study is to evaluate the efficacy and safety of the GENOSS SES in patients with acute coronary syndrome (ACS) in real-world pratice. Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
GENOSS Sirolimus Eluting Coronary Stent System
Type of treatment
Medical device
How many people
757 participants
Where
1 siteSouth Korea
Study dates
16 Mar 2020to 31 Dec 2027
How long will I take part?
3 Years
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 acute coronary syndrome treated with the GENOSS SES

<Inclusion Criteria>

  1. Patients of 19 and over
  2. Patients with acute coronary syndrome 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>

  1. Patients who are contraindicated in the use of heparin, aspirin, clopidogrel, sirolimus, cobalt chromium and contrast agents
  • However, patients with hypersensitivity to contrast agents may be eligible if it can be controlled by steroids and pheniramine. Patients with known anaphylaxis are excluded
  1. Patients who are pregnant or planning to become pregnant
  2. Patients scheduled to undergo surgery requiring the discontinuation of antiplatelet agents within 12 months from registration.
  3. Patients with a life expectancy of less than 1 year
  4. Patients who presented with cardiogenic shock at admission and are predicted to have a low chance of survival based on medical judgment.
  5. Patients who have already received treatment with another DES (Drug Eluting Stent), BVS (Bioresorbable Vascular Scaffolds), or BMS (Bare Metal Stent) at the time of registration.
  6. Patients currently participating in a randomized controlled trial involving medical devices.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 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 Acute Coronary Syndrome

The objective of this study is to evaluate the efficacy and safety of the GENOSS SES in patients with acute coronary syndrome (ACS) in real-world pratice.

Read the detailed description

The Genoss SES 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 the Genoss SES in acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention.

The Genoss SES study is a prospective, single-arm, observational study for evaluation of clinical outcomes after Genoss SES implantation in ACS patients undergoing percutaneous coronary intervention from 10 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 10 months.

Being tested
GENOSS Sirolimus Eluting Coronary Stent System
Keywords
ACS
Medical subject headings
Acute Coronary Syndrome

What participants receive

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

  • GENOSS Sirolimus Eluting Coronary Stent SystemDevice

    The GENOSS SES is a novel, biodegradable, polymer-coated, sirolimus-eluting stent with a cobalt chromium stent platform and thin strut.

Study groups in NCT06075368
Study groupRoleWhat they receive
GENOSS® DES Sirolimus Eluting Coronary Stent System / B03300.20, class [4]Patients with acute coronary syndrome treated with the GENOSS SES
Receives: Device: GENOSS Sirolimus Eluting Coronary Stent System

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: 12 months after the procedure

Secondary outcomes (9)

  1. Target lesion failure (TLF)

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

    Measured: 3 years after the procedure

  2. Target vessel failure (TVF)

    Target vessel failure (TVF) is defined as a composite of cardiac death, target vessel-related myocardial infarction (TV-MI) and clinically indicated target-vessel revascularization (TVR).

    Measured: 3 years after the procedure

  3. All-cause death

    Measured: 3 years after the procedure

  4. Cardiac death

    Measured: 3 years after the procedure

  5. All-cause death and any myocardial infarction

    Measured: 3 years after the procedure

  6. Cardiac death and target vessel-related myocardial infarction

    Measured: 3 years after the procedure

  7. Target vessel revascularization (TVR)

    Measured: 3 years after the procedure

  8. Target lesion revascularization (TLR)

    Measured: 3 years after the procedure

  9. Stent thrombosis

    Measured: 3 years 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 posted10 Oct 2023
  2. Study start16 Mar 2020
  3. Primary completion31 Dec 2025
  4. Study completion31 Dec 2027 (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
757 participants (actual)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT06075368
Sponsor's protocol ID
CIP-DS0501-10
Acronym
GENOSS ACS
Status last verified
Feb 2025
First submitted
4 Oct 2023
Last updated
11 Feb 2026
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 Acute Coronary Syndrome and Percutaneous Coronary Intervention, 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?

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 11 Feb 2026. 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: 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 NCT06075368.

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 11 Feb 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in