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Completed

NCT Number: NCT03045913

Genoss DES Prospective Multicenter Registry

This registry is a clinical post-market evaluation of the Genoss DES in subjects requiring coronary revascularization with Drug Eluting Stents (DES).

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chungbuk National University Hospital, Cheongju-si, Chungcheongbuk, South Korea

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About this study

Percutaneous coronary intervention (PCI) is the main stream of treatment of coronary artery disease. Drug-eluting stents (DES) have dramatically reduced the rates of restenosis and target lesion revascularization (TLR) compared with bare-metal stents (BMS). Newer-generation DES with a durable polymer such as Xience (Abbott, US) and Resolute (Medtronic, US) were widely used. However, the concern about late stent thrombosis due to hypersensitivity reaction from the polymer is still existed. Recently, DES with a biodegradable polymer such as Biomatrix (Biosensors, Switzerland), Nobori (Terumo, Japan), Orsiro (Biotronik, Switzerland), and Synergy (Boston Scientific, US) was rapidly adopted and it is expected to reduce the late stent thrombosis.

Recently, new biodegradable DES with thin struts was developed in South Korea. The Genoss DES (Genoss, Korea) has an L-605 cobalt chromium (CoCr) platform with a strut thickness of about 70 µm and the stent is coated a combination of Sirolimus drug with concentration of 1.15µg/mm2 and an abluminal biodegradable PLA and PLGA polymers.

This study is conducted to evaluate efficacy and safety of Genoss DES in the treatment of patients with coronary artery disease.

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 implanted Genoss DES within 1 month
  • Subject has signed informed consent for data release
  • Subject is geographically stable and willing to participate at all follow-up assessments

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
  • Planned surgery within 12 months of PCI unless dual antiplatelet therapy will be maintained
  • Currently participating in another study and primary endpoint is not reached yet.

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. Device-oriented composite end point (TLF)

    Time frame: 12 months

    Composite of cardiac death, any myocardial infarction not clearly attributable to a nontarget vessel, and clinically indicated target-lesion revascularization

Secondary outcomes

  1. Patient-oriented composite end point

    Time frame: 12 months

    Composite of any death, any myocardial infarction, and any revascularization

  2. Cardiac death

    Time frame: 12 months

    Any death due to proximate cardiac cause, unwitnessed death and death of unknown cause, and all procedure-related deaths, including those related to concomitant treatment

  3. Non-cardiac death

    Time frame: 12 months

    Any death not covered by the cardiac death

  4. Any myocardial infarction

    Time frame: 12 months

    New symptom Symptoms suggestive of ischemia + increased cardiac enzyme (Troponin >URL or CKMB >URL) or New ST elevation or LBBB

  5. Any myocardial infarction not clearly attributable to a nontarget vessel

    Time frame: 12 months

    Any myocardial infarction not clearly attributable to a nontarget vessel

  6. Any revascularization

    Time frame: 12 months

    Any repeat revascularization including all target and nontarget vessel

  7. Clinically indicated target-lesion revascularization

    Time frame: 12 months

    Any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent.

  8. Clinically indicated target-vessel revascularization

    Time frame: 12 months

    any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches and the target lesion itself.

  9. ARC defined stent thrombosis

    Time frame: 12 months

    • Definite stent thrombosis
    • Angiographic confirmation of stent thrombosis
    • Pathological confirmation of stent thrombosis
    • Probable stent thrombosis
    • Clinical definition of probable stent thrombosis is considered to have occurred after intracoronary stenting in the following cases:
    • Possible stent thrombosis - Clinical definition of possible stent thrombosis is considered to have occurred with any unexplained death from 30 days after intracoronary stenting until end of trial follow-up.

Sponsors and collaborators

Lead sponsor

Young Jin Youn, MD, PhD

Other

Collaborators

  • Genoss Co., Ltd.

Registry information

Official study title

Prospective Multicenter Observational Study for Evaluating Efficacy and Safety of GENOSS Sirolimus-eluting Stent in Patients With Coronary Artery Disease (GENOSS Registry)

Important dates

Study start
2016
Primary completion
2021
Study completion
2022
First posted
Feb 8, 2017
Registry last updated
Jan 30, 2023

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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