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Coronary Artery DiseaseGENCOMXNCT06086496

Effectiveness and Safety of Abluminal Biodegradable Polymer Sirolimus-eluting Stent (GENOSS® DES)

An observational study of Coronary Artery Disease and Percutaneous Coronary Intervention, run by Genoss Co., Ltd. at 1 site in South Korea.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

In this study, the investigators evaluated the effectiveness and safety of using the GENOSS® DES, which has a biodegradable polymer only on the inner wall of the blood vessel, for patients(all-comers) with coronary artery disease who require percutaneous coronary intervention through stent insertion. Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
GENOSS® DES Sirolimus Eluting Coronary Stent System
Type of treatment
Medical device
How many people
1,000 participants
Where
1 siteSouth Korea
Study dates
15 Jul 2022to 31 Dec 2027
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: Coronary artery disease patients who underwent coronary intervention using the GENOSS® DES

<Inclusion Criteria>

  1. Adults over 19 years of age
  2. Patients with typical symptoms or objective evidence of myocardial ischemia and eligible for coronary angioplasty.
  3. Severe coronary artery stenosis suitable for GENOSS® DES insertion
  4. Patients who agree to the research protocol and clinical follow-up plan and give written informed consent in the consent form approved by the Institutional Review Board/Ethics Committee of each research institution.

<Exclusion Criteria>

  1. Test subjects with known hypersensitivity or contraindications to the following drugs or substances: heparin, aspirin, clopidogrel, sirolimus, contrast medium (however, even subjects with hypersensitivity to contrast medium can be controlled by steroids and pheniramine) In this case, registration is possible, but if there is known anaphylaxis, it is excluded)
  2. Patients who also received other drug-eluting stents
  3. If you have a disease with a remaining life expectancy of less than 1 year
  4. Pregnant or lactating women or women who may be pregnant
  5. Cases in which the patient was admitted to the hospital due to psychogenic shock and the likelihood of survival is medically expected to be low.
  6. Patients judged by researchers to be unsuitable for research

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

South Korea1 site

  • Korea University Anam Hospital

    Seoul, Seoul

Other trials in South Korea

About this study

Official title: Evaluation of Effectiveness and Safety of Abluminal Biodegradable Polymer Sirolimus-eluting Stent in Routine Clinical Practice: A Prospective, Single-arm, Multicenter, Observational Study (The GENCOMX Registry)

In this study, the investigators evaluated the effectiveness and safety of using the GENOSS® DES, which has a biodegradable polymer only on the inner wall of the blood vessel, for patients(all-comers) with coronary artery disease who require percutaneous coronary intervention through stent insertion.

Read the detailed description

This study is a sponsor-initiated clinical trial (SIT) that enrolls patients who underwent percutaneous coronary intervention using the GENOSS® DES drug-eluting stent.

As it is a prospective, multicenter, observational study, the number of subjects is not separately calculated, but the plan is to recruit a total of 1,000 participants at 7 institutions during the study registration period.

Being tested
GENOSS® DES Sirolimus Eluting Coronary Stent System
Medical subject headings
Coronary Artery Disease

What participants receive

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

  • GENOSS® DES Sirolimus Eluting Coronary Stent SystemDevice

    The GENOSS® DES is L-605 cobalt chromium (CoCr) platform with a strut thickness of 70µm Sirolimus drug with concentration of 1.15µg/mm2 Abluminal biodegradable PLA and PLGA polymers.

Study groups in NCT06086496
Study groupRoleWhat they receive
GENOSS® DES Sirolimus Eluting Coronary Stent System / B03300.20, class [4]Patients with coronary artery disease who require interventional treatment through stent insertion in real-world practice (all-comer)
Receives: Device: GENOSS® DES Sirolimus Eluting Coronary Stent System

What is being measured

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

  1. Target Lesion Failure (TLF)

    The composite end point of cardiac death, TV-MI (target vessel-MI), and TLR (target lesion revascularization)

    Measured: at 12 months after the procedure

Secondary outcomes (8)

  1. All deaths

    Measured: at 12 months after the procedure

  2. Cardiac death

    Measured: at 12 months after the procedure

  3. TV-MI (target vessel-myocardial infarction)

    Measured: at 12 months after the procedure

  4. any MI (myocardial infarction)

    Measured: at 12 months after the procedure

  5. ID-TVR (ischemia-driven target vessel revascularization)

    Measured: at 12 months after the procedure

  6. ID-TLR (ischemia-driven target lesion revascularization)

    Measured: at 12 months after the procedure

  7. Stent thrombosis by ARC definition

    Measured: at 12 months after the procedure

  8. Procedure success

    When the final internal stenosis rate is less than 30% as assessed visually on angiography after the procedure and there is no death, Q-wave myocardial infarction, or urgent revascularization during hospitalization.

    Measured: during the hospitalization period (up to 3 days)

Timeline

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

  1. First posted17 Oct 2023
  2. Study start15 Jul 2022
  3. Primary completion31 Dec 2027 (estimated)
  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
1,000 participants (estimated)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06086496
Sponsor's protocol ID
2022AN0320
Acronym
GENCOMX
Status last verified
Sep 2025
First submitted
4 Oct 2023
Last updated
6 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The data set is available from the the corresponding author upon reasonable request.

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease 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: enrolling by invitation, as of the sponsor's last update on 6 Oct 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?

Target Lesion Failure (TLF) (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 NCT06086496.

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 6 Oct 2025.

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