AzTrials
AzTrials

Coronary Artery DiseaseGENOSSRegistryNCT06066476

Efficacy and Safety of GENOSS® DES in Patients with Coronary Artery Disease

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

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The objective of this study is to evaluate the efficacy and safety of the GENOSS DES in patients with coronary artery disease in real-world pratice. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Coronary Artery Disease
How many people
1,022 participants
Where
1 siteSouth Korea
Study dates
24 Jun 2017to 31 Oct 2024
How long will I take part?
12 Months
Phase
Observational
Are there results?
None posted in the registry

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 DES

<Inclusion Criteria>

  1. Patients of 19 and over
  2. Patients eligible for treatment of coronary artery disease using GENOSSTM DES
  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 research 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)
  2. Patients who are pregnant or planning to become pregnant
  3. Patients scheduled to undergo surgery requiring the discontinuation of antiplatelet agents within 12 months from registration
  4. Patients with a life expectancy of less than 1 year
  5. Patients who presented with cardiogenic shock at admission and are predicted to have a low chance of survival based on medical judgment
  6. 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
  7. Patients currently participating in a randomized controlled trial involving medical devices

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Korea University Guro Hospital

    Seoul, 08308

Other trials in South Korea

About this study

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

The objective of this study is to evaluate the efficacy and safety of the GENOSS DES in patients with coronary artery disease in real-world pratice.

Read the detailed description

The Genoss DES 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 DES in all-comer patients undergoing percutaneous coronary intervention.

The Genoss DES registry is a prospective, single-arm, observational study for evaluation of clinical outcomes after Genoss DES implantation in all-comer patients undergoing percutaneous coronary intervention from 12 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 12 months.

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.

Study groups in NCT06066476
Study groupRoleWhat they receive
GENOSS Sirolimus Eluting Coronary Stent SystemPatients with coronary artery disease treated with the GENOSS DES

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 posted4 Oct 2023
  2. Study start24 Jun 2017
  3. Primary completion31 Oct 2024
  4. Study completion31 Oct 2024

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
1,022 participants (actual)
Target duration
12 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06066476
Sponsor's protocol ID
CIP-DS0501-08
Acronym
GENOSSRegistry
Status last verified
Feb 2025
First submitted
27 Sep 2023
Last updated
20 Feb 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, 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: finished, as of the sponsor's last update on 20 Feb 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 NCT06066476.

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 20 Feb 2025.

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