GENOSS Coronary Stent Clinical Trial

Comparison Between Abluminal Biodegradable Polymer Ultrathin Sirolimus-eluting Stent and Durable-polymer Everolimus-eluting Stent (GENOSS Randomized Clinical Trial)

This study aims to evaluate the efficacy and safety of abluminal biodegradable polymer ultrathin sirolimus-eluting stent (Genoss stent) as compared with a durable-polymer everolimus-eluting stent (Xience stent) in patients with coronary artery disease.

Study Overview

• Status: Recruiting
• Conditions: Ischemic Heart Disease
• Intervention / Treatment: Device: Implanatation of Genoss DES sirolimus-eluting coronary system; Device: Implanatation of Xience DES everolimus-eluting coronary system

Detailed Description

After the introduction of the drug-eluting stents (DES), the rates of device-related failure or target lesion failure (TLF) such as restenosis has been markedly decreased, compared with the era of bare-metal stents. Nevertheless, the risk of ischemic events including very late stent thrombosis after percutaneous coronary intervention (PCI) has still remained even though the use of DES, presumably because of hypersensitivity to the polymer with persistent inflammation and delayed re-endothelialization. To overcome these issues, second-generation DES with thinner stent strut and biocompatible or biodegradable polymer were developed. Several trials demonstrated that second-generation DES provides more favorable outcome in comparison with first-generation DES. Especially, among second-generation DES, biodegradable polymer DES showed better ischemic outcomes compared to durable polymer DES in some studies.

Genoss DES™ (Genoss Company Limited, Suwon, Korea) is one of newer second-generation DESs with a cobalt-chromium platform with an abluminal biodegradable polymer containing sirolimus. The Genoss DES™ is the first Korean sirolimus-eluting stent on the market and it has ultrathin strut with 70 μm strut thickness with 3 μm thin abluminal polymer coating containing Sirolimus. The polymer is designed to release approximately 70% of the total drug amount within 30 days of the implantation and is entirely absorbable within 9 months. Thus, only the metal component of the stent will remain. In the first-in-man trial comparing Genoss DES™ and Promus Element™ stent (Boston Scientific Co., Natick, MA, USA), angiographic and clinical outcomes were similar at a 9-month follow-up. However, the study was too small to conclude that the Genoss DES™ is safe and efficient for de novo coronary stenosis. To date, there has been no large-scale randomized trial evaluating the safety and efficacy of Genoss DES™.

Therefore, the purpose of this trial is to determine the efficacy and safety of Genoss DES™ as compared with Xience everolimus-eluting stent (Abbott Vascular, Santa Clara, California, USA) which is widely used and has proven efficacy and safety.

• Study Type: Interventional
• Enrollment (Anticipated): 850
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hyeon-Cheol Gwon, MD, PhD; Phone Number: 82-2-3410-3694; Email: hcgwon@naver.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Recruiting
    • Cardiac and Vascular Center; Samsung Medical Center
    • Contact: Hyeon-Cheol Gwon, Professor; Phone Number: 82234103419; Email: hc.gwon@samsung.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

① Subject must be at least 19 years of age

② Subject who is able to understand risks, benefits and treatment alternatives and sign informed consent voluntarily.

③ Patients with stable coronary artery disease or acute coronary syndrome and at least one lesion with greater than 50% diameter stenosis suitable for stent implantation

Exclusion Criteria:

• Pregnant women ② Patients unable to provide consent, ③ Patients with known intolerance to aspirin, clopidogrel, ticagrelor, prasugrel, heparin or components of drug-eluting stents (sirolimus or everolimus)

  • Patients who have non-cardiac co-morbid conditions with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GENOSS stent arm; Coronary lesions of the subjects this arm will be treated with GENOSS stent when in need of stent implantation	Device: Implanatation of Genoss DES sirolimus-eluting coronary system; Percutaneous coronary intervention will proceed as per clinical guidelines, under operator's discretion. Genoss stent will be implanted if the lesion is deemed necessary to be revascularized by stenting
Active Comparator: XIENCE stent arm; Coronary lesions of the subjects this arm will be treated with Xience stent when in need of stent implantation	Device: Implanatation of Xience DES everolimus-eluting coronary system; Percutaneous coronary intervention will proceed as per clinical guidelines, under operator's discretion. Xience stent will be implanted if the lesion is deemed necessary to be revascularized by stenting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TLF at 1 year	A composite of cardiac death, target vessel-MI, or clinically indicated TLR by percutaneous or surgical methods at 1 year	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TLF at 3 years	A composite of cardiac death, target vessel-MI, or clinically indicated TLR by percutaneous or surgical methods at 3 year	3 years
Target vessel failure	a composite of cardiac death, target vessel-MI, or clinically indicated target-vessel revascularization [TVR] by percutaneous or surgical methods at 1 and 3 years	1 and 3 years
All-cause death	All-cause death at 1 and 3 years	1 and 3 years
Cardiac death	Cardiac death at 1 and 3 years	1 and 3 years
MI	Myocardial infarction, as defined by the protocol of this study, at 1 and 3 years	1 and 3 years
Stent thrombosis	F. Stent thrombosis (definite or probable by Academic Research Consortium [ARC] definition) at 1 and 3 years	1 and 3 years
All-cause death or MI	All-cause death or MI at 1 and 3 years	1 and 3 years
Cardiac death or MI	Cardiac death or MI at 1 and 3 years	1 and 3 years
Cardiac death, MI or stent thrombosis	Cardiac death, MI or stent thrombosis at 1 and 3 years	1 and 3 years
Stroke	Stroke at 1 and 3 years	1 and 3 years
Clinically indicated TLR	Clinically indicated target lesion revascularization at 1 and 3 years	1 and 3 years
Clinically indicated TVR	Clinically indicated target vessel revascularization at 1 and 3 years	1 and 3 years
Any revascularization	Any revascularization at 1 and 3 years	1 and 3 years
Major bleeding	Major Bleeding (BARC [Bleeding Academic Research Consortium] types 3 or 5) at 1 and 3 years	1 and 3 years
Bleeding	Bleeding (BARC type 2, 3, or 5) at 1 and 3 years	1 and 3 years
Restricted mean survival time for the TLF	Restricted mean survival time for the TLF over 1 and 3 years	1 and 3 years

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Collaborators: Genoss Company Limited, Suwon, Korea
• Investigators: Principal Investigator: Hyeon-Cheol Hyeon-Cheol, MD, PhD, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2022
• Primary Completion (Anticipated): June 30, 2027
• Study Completion (Anticipated): June 30, 2027

Study Registration Dates

• First Submitted: June 29, 2022
• First Submitted That Met QC Criteria: June 29, 2022
• First Posted (Actual): July 6, 2022

Study Record Updates

• Last Update Posted (Actual): July 6, 2022
• Last Update Submitted That Met QC Criteria: June 29, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: ischemic heart disease; acute coronary syndrome; coronary stent
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Physiological Effects of Drugs; Anti-Infective Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antifungal Agents; Everolimus; Sirolimus
• Other Study ID Numbers: GENOSS

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: Yes
• product manufactured in and exported from the U.S.: Yes