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Enrolling by Invitation

NCT Number: NCT06086496

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

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.

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 Anam Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

<Inclusion Criteria>

  • Adults over 19 years of age
  • Patients with typical symptoms or objective evidence of myocardial ischemia and eligible for coronary angioplasty.
  • Severe coronary artery stenosis suitable for GENOSS® DES insertion
  • 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>

  • 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)
  • Patients who also received other drug-eluting stents
  • If you have a disease with a remaining life expectancy of less than 1 year
  • Pregnant or lactating women or women who may be pregnant
  • 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.
  • Patients judged by researchers to be unsuitable for research

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. All deaths

    Time frame: at 12 months after the procedure

  2. Cardiac death

    Time frame: at 12 months after the procedure

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

    Time frame: at 12 months after the procedure

  4. any MI (myocardial infarction)

    Time frame: at 12 months after the procedure

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

    Time frame: at 12 months after the procedure

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

    Time frame: at 12 months after the procedure

  7. Stent thrombosis by ARC definition

    Time frame: at 12 months after the procedure

  8. Procedure success

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

    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.

Sponsors and collaborators

Lead sponsor

Genoss Co., Ltd.

Industry

Registry information

Official study 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)

Acronym: GENCOMX

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Oct 17, 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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