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Enrolling by invitation NCT06086496

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

— Observational Coronary Artery Disease Percutaneous Coronary Intervention

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GENOSS® DES Sirolimus Eluting Coronary Stent System.
Who it may be relevant to
Registry conditions: Coronary Artery Disease, Percutaneous Coronary Intervention. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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)

Overview

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.

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.

Interventions

  • Device GENOSS® DES Sirolimus Eluting Coronary Stent System
    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 outcome measures

  • Target Lesion Failure (TLF) [Time frame: at 12 months after the procedure]
Secondary outcome measures (8)
  • All deaths [Time frame: at 12 months after the procedure]
  • Cardiac death [Time frame: at 12 months after the procedure]
  • TV-MI (target vessel-myocardial infarction) [Time frame: at 12 months after the procedure]
  • any MI (myocardial infarction) [Time frame: at 12 months after the procedure]
  • ID-TVR (ischemia-driven target vessel revascularization) [Time frame: at 12 months after the procedure]
  • ID-TLR (ischemia-driven target lesion revascularization) [Time frame: at 12 months after the procedure]
  • Stent thrombosis by ARC definition [Time frame: at 12 months after the procedure]
  • Procedure success [Time frame: during the hospitalization period (up to 3 days)]

Eligibility criteria

<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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

South Korea · 1 center
  • Korea University Anam Hospital — Seoul

Identifiers

NCT: NCT06086496 · 2022AN0320

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗