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NCT Number: NCT05448625

Genoss DES in Patients With a High Risk of Ischemic Events (GENTLE Registry)

This is a prospective cohort study to evaluate the long-term effect and safety of Genoss drug-eluting stents (DES) in patients with coronary artery disease with high ischemic features.

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Key information

Conditions

Drug-Eluting Stent Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Yongin Severance Hospital

Yongin, Gyeonggi-do, 16995, South Korea

About this study

It is known that ischemic events after percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG) increase as the anatomical, physiological, or functional complexity of coronary artery disease increases. Recently, the concept of complex higher-risk and clinically indented procedure (CHIP) has been proposed, which includes patients with various medical conditions, patients with various heart conditions, and patients with technically complex PCI. Until now, Genoss stents have no data on the evaluation of stents in patients with coronary artery disease and high ischemic features.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject is ≥ 19 years
  • Subject has signed informed consent for data release

Exclusion criteria

  • Subject did not sign informed consent for data release
  • Known intolerance to aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation / antiplatelet therapy required for PCI, cobalt chromium, Sirolimus or contrast media
  • Pregnancy
  • Subject with life expectancy less than 12 months
  • Subject with cardiogenic shock

Treatment and study plan

Genoss DES

Device

The Genoss DES (Genoss, Korea) L-605 cobalt chromium (CoCr) platform with a strut thickness of 70 µm Sirolimus drug with concentration of 1.15µg/mm2 Abluminal biodegradable PLA and PLGA polymers.

Primary outcomes

  1. Number of participants with device-oriented compopsite endpoint (TLF)

    Time frame: 12 months

    A composite rate of cardiac death (CD), target-vessel myocardial infarction (TV-MI), Ischemic driven target lesion revascularization (ID-TLR)

Secondary outcomes

  1. Number of participants with patient-oriented composite endpoint

    Time frame: 12 months

    A composite rate of all death, all myocardial infarction, and all revascularization

  2. Number of participants with all death

    Time frame: 12 months

    A composite rate of all death

  3. Number of participants with cardiac death

    Time frame: 12 months

    A composite rate of cardiac death

  4. Number of participants with non-cardiac death

    Time frame: 12 months

    A composite rate of non-cardiac death

  5. Number of participants with all myocardial infarction

    Time frame: 12 months

    A composite rate of all myocardial infarction

  6. Number of participants with target-vessel myocardial infarction (TV-MI)

    Time frame: 12 months

    A composite rate of target-vessel myocardial infarction (TV-MI)

  7. Number of participants with all revascularization

    Time frame: 12 months

    A composite rate of all revascularization

  8. Number of participants with ischemic driven target lesion revascularization (ID-TLR)

    Time frame: 12 months

    A composite rate of ischemic driven target lesion revascularization (ID-TLR)

  9. Number of participants with stent thrombosis

    Time frame: Within 24 hours, 30 days, 12 months

    A composite rate of stent thrombosis

  10. Number of participants with non-ischemic targeted lesion perfusion

    Time frame: 12 months

    A composite rate of non-ischemic targeted lesion perfusion

  11. Number of participants with Non target vessel myocardial infarction

    Time frame: 12 months

    A composite rate of Non target vessel myocardial infarction

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Collaborators

  • Genoss Co., Ltd.
  • Severance Hospital

Registry information

Official study title

Safety and Efficacy of Sirolimus-eluting Biodegradable Abluminal Coating Stents in Patients With a High Risk of Ischemic Events: a Single-center, Prospective, Observational Trial (GENTLE Registry)

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jul 7, 2022
Registry last updated
Nov 25, 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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