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OpenTrials
Enrolling by Invitation

NCT Number: NCT06168305

Safety and Effectiveness of GENOSS® DES in Patients With Multivessel Coronary Artery Disease

The investigators intend to establish a multicenter prospective observational study by enrolling and tracking patients with multivessel coronary artery disease (MVCAD) using Genoss DES, a device manufactured with pure domestic technology. The study aims to evaluate the efficacy and safety of Genoss DES in MVCAD patients.

Enrolling by Invitation

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Korea University GURO Hospital

Seoul, 08308, South Korea

About this study

This study is a sponsor-driven clinical trial (SIT) that aims to enroll patients who have undergone treatment for multivessel coronary artery disease using Genoss stents. The study involves collecting data on the clinical and surgical processes of patients and tracking the occurrence of clinical events.

This prospective, multicenter observational study registers patients with acute coronary artery disease who have been treated with GENOSS stents at a total of 8 institutions.

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

<Inclusion Criteria>

  • Adults over 19 years of age
  • Subjects with multivessel coronary artery disease (MVCAD) (However, subject registration is possible even if the treatment area is restenosis or recurrent lesion, including new lesions)
  • Subjects who underwent percutaneous coronary intervention (PCI) with GENOSS® DES
  • Research subjects who agree to the research protocol and clinical follow-up plan, voluntarily decide to participate in this clinical study, and give written consent in the informed consent form.

(However, in the case of foreigners, only those who can speak Korean fluently and understand Korean documents such as the consent form are included.)

<Exclusion Criteria>

  • 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)
  • When balloon angioplasty is performed on a stenotic area, the balloon cannot be expanded.
  • Those whose remaining life expectancy is less than 1 year
  • Expecting to become pregnant, pregnant or lactating woman
  • The patient was admitted to the hospital due to cardiogenic shock and was predicted to have a low chance of survival based on medical judgment.

Subject

  • If the researcher determines that the product is not suitable for this clinical study or may increase the risks associated with participation in the study.
  • Foreigners who cannot speak Korean fluently and have difficulty understanding Korean documents

Treatment and study plan

GENOSS® DES Sirolimus Eluting Coronary Stent System

Device

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.

Primary outcomes

  1. Target Lesion Failure (TLF)

    Time frame: at 12 months after the procedure

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

Secondary outcomes

  1. Major adverse cardiac events (MACE)

    Time frame: at 12 months after the procedure

    The composite end point of death, myocardial infarction, target lesion revascularization

  2. Cardiac death

    Time frame: at 12 months after the procedure

  3. Non-cardiac death

    Time frame: at 12 months after the procedure

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

    Time frame: at 12 months after the procedure

  5. Non-target vessel myocardial infarction

    Time frame: at 12 months after the procedure

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

    Time frame: at 12 months after the procedure

  7. Non-ischemia driven target vessel revascularization

    Time frame: at 12 months after the procedure

  8. Incidence rate of acute stent thrombosis within 24 hours, subacute stent thrombosis within 30 days, and late stent thrombosis at 1 year

    Time frame: within 24 hours, 30 days, 1 year

    Acute (within 24 hours), subacute (within 30 days), late (within 1 year)

  9. Device success

    Time frame: during the procedure

    The clinical device is successfully delivered to the target lesion, inflated normally, and recovered intact.

  10. Procedure success

    Time frame: during the hospitalization period (up to 3 days)

    When the final residual lesion stenosis is less than 50% using any surgical method, and there is no post-procedural death, myocardial infarction, or revascularization during the hospitalization period.

Sponsors and collaborators

Lead sponsor

Genoss Co., Ltd.

Industry

Registry information

Official study title

Safety and Effectiveness of GENOSS® DES (Sirolimus-eluting Coronary Stent System) in Patients With Multivessel Coronary Artery Disease (MVCAD): A Multicenter, Prospective, Observational Study

Acronym: GENOSS-MV

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Dec 13, 2023
Registry last updated
Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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