Genoss DES Prospective Multicenter Registry

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

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

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction; Myocardial Ischemia; Coronary Artery Disease
• Intervention / Treatment: Device: Genoss DES

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 2000

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
    • Kosin University Gospel Hospital
  • Incheon, Korea, Republic of
    • Gachon University Gil Medical Center
  • Seoul, Korea, Republic of
    • Ewha Womans University Mokdong Hospital
  • Seoul, Korea, Republic of
    • Gangnam Severance Hospital
  • Seoul, Korea, Republic of
    • Korea University Anam Hospital
  • Seoul, Korea, Republic of
    • KangNam Sacred Heart Hospital
  • Seoul, Korea, Republic of
    • Severance Cardiovascular Hospital
  • Chungcheongbuk
    • Cheongju, Chungcheongbuk, Korea, Republic of
      • Chungbuk National University Hospital
  • Chungcheongnam
    • Cheonan, Chungcheongnam, Korea, Republic of
      • Dankook University Hospital
  • Gangwon
    • Chuncheon, Gangwon, Korea, Republic of
      • Chuncheon Sacred Heart Hospital
    • Chuncheon, Gangwon, Korea, Republic of
      • Kangwon National University Hospital
    • Gangneung, Gangwon, Korea, Republic of
      • Gangneung Asan Hospital
    • Wonju, Gangwon, Korea, Republic of, 220060
      • Wonju Severance Christian Hospital
  • Gyeonggi
    • Goyang, Gyeonggi, Korea, Republic of
      • Inje University Ilsan Paik Hospital
    • Goyang, Gyeonggi, Korea, Republic of
      • Myongji Hospital, Hanyang University College of Medicine
    • Goyang, Gyeonggi, Korea, Republic of
      • National Health Insurance Service Ilsan Hospital
    • Seongnam, Gyeonggi, Korea, Republic of
      • CHA Bundang Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All-comers patient population with all subjects requiring coronary revascularization with a Drug Eluting Stent (DES)

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Genoss DES; Subject implanted Genoss DES for coronary artery disease	Device: Genoss DES; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device-oriented composite end point (TLF)	Composite of cardiac death, any myocardial infarction not clearly attributable to a nontarget vessel, and clinically indicated target-lesion revascularization	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-oriented composite end point	Composite of any death, any myocardial infarction, and any revascularization	12 months
Cardiac death	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	12 months
Non-cardiac death	Any death not covered by the cardiac death	12 months
Any myocardial infarction	New symptom Symptoms suggestive of ischemia + increased cardiac enzyme (Troponin >URL or CKMB >URL) or New ST elevation or LBBB	12 months
Any myocardial infarction not clearly attributable to a nontarget vessel	Any myocardial infarction not clearly attributable to a nontarget vessel	12 months
Any revascularization	Any repeat revascularization including all target and nontarget vessel	12 months
Clinically indicated target-lesion revascularization	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.	12 months
Clinically indicated target-vessel revascularization	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.	12 months
ARC defined stent thrombosis	Definite stent thrombosisAngiographic confirmation of stent thrombosisPathological 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.	12 months

Collaborators and Investigators

• Sponsor: Young Jin Youn, MD, PhD
• Collaborators: Genoss Co., Ltd.
• Investigators: Principal Investigator: Junghan Yoon, MD, PhD, Wonju Severance Christian Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2016
• Primary Completion (Actual): November 29, 2021
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: January 23, 2017
• First Submitted That Met QC Criteria: February 3, 2017
• First Posted (Estimate): February 8, 2017

Study Record Updates

• Last Update Posted (Estimate): January 30, 2023
• Last Update Submitted That Met QC Criteria: January 27, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; Percutaneous Coronary Intervention; Multicenter; Observational registry; Stenting; Coronary revascularization; All-comers open label registry; Genoss DES
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Myocardial Infarction; Infarction; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Ischemia
• Other Study ID Numbers: Yonsei University

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No