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Ischemic Heart DiseaseNCT05444452

GENOSS Coronary Stent Clinical Trial

A study testing Implanatation of Genoss DES sirolimus-eluting coronary system and Implanatation of Xience DES everolimus-eluting coronary system in people with Ischemic Heart Disease, run by Samsung Medical Center at 1 site in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study aims to evaluate the efficacy and safety of abluminal biodegradable polymer ultrathin sirolimus-eluting stent (Genoss stent) as compared with a durable-polymer everolimus-eluting stent (Xience stent) 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
Ischemic Heart Disease
What is being tested?
Implanatation of Genoss DES sirolimus-eluting coronary system and Implanatation of Xience DES everolimus-eluting coronary system
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
850 participants
Where
1 siteSouth Korea
Study dates
24 Apr 2022to 30 Jun 2027
Phase
Interventional
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

Who may be able to join

  • ① Subject must be at least 19 years of age
  • ② Subject who is able to understand risks, benefits and treatment alternatives and sign informed consent voluntarily.
  • ③ Patients with stable coronary artery disease or acute coronary syndrome and at least one lesion with greater than 50% diameter stenosis suitable for stent implantation

Who cannot join

  • Pregnant women ② Patients unable to provide consent, ③ Patients with known intolerance to aspirin, clopidogrel, ticagrelor, prasugrel, heparin or components of drug-eluting stents (sirolimus or everolimus)
  • Patients who have non-cardiac co-morbid conditions with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment)

Trial locations and contacts

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

Hyeon-Cheol Gwon, MD, PhD contact

82-2-3410-3694

hcgwon@naver.com

South Korea1 site, 1 recruiting

  • Cardiac and Vascular Center; Samsung Medical Center

    Seoul, 135-710

    Hyeon-Cheol Gwon, Professor, 82234103419, hc.gwon@samsung.com

    Recruiting

Other trials in South Korea

About this study

Official title: Comparison Between Abluminal Biodegradable Polymer Ultrathin Sirolimus-eluting Stent and Durable-polymer Everolimus-eluting Stent (GENOSS Randomized Clinical Trial)

This study aims to evaluate the efficacy and safety of abluminal biodegradable polymer ultrathin sirolimus-eluting stent (Genoss stent) as compared with a durable-polymer everolimus-eluting stent (Xience stent) in patients with coronary artery disease.

Read the detailed description

After the introduction of the drug-eluting stents (DES), the rates of device-related failure or target lesion failure (TLF) such as restenosis has been markedly decreased, compared with the era of bare-metal stents. Nevertheless, the risk of ischemic events including very late stent thrombosis after percutaneous coronary intervention (PCI) has still remained even though the use of DES, presumably because of hypersensitivity to the polymer with persistent inflammation and delayed re-endothelialization. To overcome these issues, second-generation DES with thinner stent strut and biocompatible or biodegradable polymer were developed. Several trials demonstrated that second-generation DES provides more favorable outcome in comparison with first-generation DES. Especially, among second-generation DES, biodegradable polymer DES showed better ischemic outcomes compared to durable polymer DES in some studies.

Genoss DES™ (Genoss Company Limited, Suwon, Korea) is one of newer second-generation DESs with a cobalt-chromium platform with an abluminal biodegradable polymer containing sirolimus. The Genoss DES™ is the first Korean sirolimus-eluting stent on the market and it has ultrathin strut with 70 μm strut thickness with 3 μm thin abluminal polymer coating containing Sirolimus. The polymer is designed to release approximately 70% of the total drug amount within 30 days of the implantation and is entirely absorbable within 9 months. Thus, only the metal component of the stent will remain. In the first-in-man trial comparing Genoss DES™ and Promus Element™ stent (Boston Scientific Co., Natick, MA, USA), angiographic and clinical outcomes were similar at a 9-month follow-up. However, the study was too small to conclude that the Genoss DES™ is safe and efficient for de novo coronary stenosis. To date, there has been no large-scale randomized trial evaluating the safety and efficacy of Genoss DES™.

Therefore, the purpose of this trial is to determine the efficacy and safety of Genoss DES™ as compared with Xience everolimus-eluting stent (Abbott Vascular, Santa Clara, California, USA) which is widely used and has proven efficacy and safety.

Being tested
Implanatation of Genoss DES sirolimus-eluting coronary system, Implanatation of Xience DES everolimus-eluting coronary system
Keywords
coronary stent, ischemic heart disease, acute coronary syndrome
Medical subject headings
Myocardial Ischemia, Acute Coronary Syndrome

What participants receive

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

  • Implanatation of Genoss DES sirolimus-eluting coronary systemDevice

    Percutaneous coronary intervention will proceed as per clinical guidelines, under operator's discretion. Genoss stent will be implanted if the lesion is deemed necessary to be revascularized by stenting

  • Implanatation of Xience DES everolimus-eluting coronary systemDevice

    Percutaneous coronary intervention will proceed as per clinical guidelines, under operator's discretion. Xience stent will be implanted if the lesion is deemed necessary to be revascularized by stenting

Study groups in NCT05444452
Study groupRoleWhat they receive
GENOSS stent armExperimentalCoronary lesions of the subjects this arm will be treated with GENOSS stent when in need of stent implantation
Receives: Device: Implanatation of Genoss DES sirolimus-eluting coronary system
XIENCE stent armActive comparatorCoronary lesions of the subjects this arm will be treated with Xience stent when in need of stent implantation
Receives: Device: Implanatation of Xience DES everolimus-eluting coronary system

What is being measured

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

  1. TLF at 1 year

    A composite of cardiac death, target vessel-MI, or clinically indicated TLR by percutaneous or surgical methods at 1 year

    Measured: 1 year

Secondary outcomes (16)

  1. TLF at 3 years

    A composite of cardiac death, target vessel-MI, or clinically indicated TLR by percutaneous or surgical methods at 3 year

    Measured: 3 years

  2. Target vessel failure

    a composite of cardiac death, target vessel-MI, or clinically indicated target-vessel revascularization [TVR] by percutaneous or surgical methods at 1 and 3 years

    Measured: 1 and 3 years

  3. All-cause death

    All-cause death at 1 and 3 years

    Measured: 1 and 3 years

  4. Cardiac death

    Cardiac death at 1 and 3 years

    Measured: 1 and 3 years

  5. MI

    Myocardial infarction, as defined by the protocol of this study, at 1 and 3 years

    Measured: 1 and 3 years

  6. Stent thrombosis

    1. Stent thrombosis (definite or probable by Academic Research Consortium [ARC] definition) at 1 and 3 years

    Measured: 1 and 3 years

  7. All-cause death or MI

    All-cause death or MI at 1 and 3 years

    Measured: 1 and 3 years

  8. Cardiac death or MI

    Cardiac death or MI at 1 and 3 years

    Measured: 1 and 3 years

  9. Cardiac death, MI or stent thrombosis

    Cardiac death, MI or stent thrombosis at 1 and 3 years

    Measured: 1 and 3 years

  10. Stroke

    Stroke at 1 and 3 years

    Measured: 1 and 3 years

  11. Clinically indicated TLR

    Clinically indicated target lesion revascularization at 1 and 3 years

    Measured: 1 and 3 years

  12. Clinically indicated TVR

    Clinically indicated target vessel revascularization at 1 and 3 years

    Measured: 1 and 3 years

  13. Any revascularization

    Any revascularization at 1 and 3 years

    Measured: 1 and 3 years

  14. Major bleeding

    Major Bleeding (BARC [Bleeding Academic Research Consortium] types 3 or 5) at 1 and 3 years

    Measured: 1 and 3 years

  15. Bleeding

    Bleeding (BARC type 2, 3, or 5) at 1 and 3 years

    Measured: 1 and 3 years

  16. Restricted mean survival time for the TLF

    Restricted mean survival time for the TLF over 1 and 3 years

    Measured: 1 and 3 years

Timeline

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

  1. First posted6 Jul 2022
  2. Study start24 Apr 2022
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jun 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
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
850 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05444452
Sponsor's protocol ID
GENOSS
Status last verified
Jun 2022
First submitted
29 Jun 2022
Last updated
6 Jul 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Implanatation of Genoss DES sirolimus-eluting coronary system and Implanatation of Xience DES everolimus-eluting coronary system in people with Ischemic Heart Disease, run by Samsung Medical Center 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 2 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: looking for participants now, as of the sponsor's last update on 6 Jul 2022. 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?

Contact Hyeon-Cheol Gwon, MD, PhD (82-2-3410-3694, hcgwon@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

TLF at 1 year (time frame: 1 year). 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 NCT05444452.

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 Jul 2022.

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