GENOSS Coronary Stent Clinical Trial

Ischemic Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05444452
• Other study ID #: GENOSS
• Status: Recruiting
• Phase: N/A
• Start date: April 24, 2022
• Est. completion date: June 30, 2027

Study information

• Verified date: June 2022
• Source: Samsung Medical Center
• Contact: Hyeon-Cheol Gwon, MD, PhD
• Phone: 82-2-3410-3694
• Email: hcgwon[@]naver.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 850
• Est. completion date: June 30, 2027
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

? Subject must be at least 19 years of age

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

? 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 ? Patients unable to provide consent, ? 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)

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

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
• 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

Locations

Country	Name	City	State
Korea, Republic of	Cardiac and Vascular Center; Samsung Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Samsung Medical Center	Genoss Company Limited, Suwon, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	All-cause death	All-cause death at 1 and 3 years	1 and 3 years
Secondary	Cardiac death	Cardiac death at 1 and 3 years	1 and 3 years
Secondary	MI	Myocardial infarction, as defined by the protocol of this study, at 1 and 3 years	1 and 3 years
Secondary	Stent thrombosis	F. Stent thrombosis (definite or probable by Academic Research Consortium [ARC] definition) at 1 and 3 years	1 and 3 years
Secondary	All-cause death or MI	All-cause death or MI at 1 and 3 years	1 and 3 years
Secondary	Cardiac death or MI	Cardiac death or MI at 1 and 3 years	1 and 3 years
Secondary	Cardiac death, MI or stent thrombosis	Cardiac death, MI or stent thrombosis at 1 and 3 years	1 and 3 years
Secondary	Stroke	Stroke at 1 and 3 years	1 and 3 years
Secondary	Clinically indicated TLR	Clinically indicated target lesion revascularization at 1 and 3 years	1 and 3 years
Secondary	Clinically indicated TVR	Clinically indicated target vessel revascularization at 1 and 3 years	1 and 3 years
Secondary	Any revascularization	Any revascularization at 1 and 3 years	1 and 3 years
Secondary	Major bleeding	Major Bleeding (BARC [Bleeding Academic Research Consortium] types 3 or 5) at 1 and 3 years	1 and 3 years
Secondary	Bleeding	Bleeding (BARC type 2, 3, or 5) at 1 and 3 years	1 and 3 years
Secondary	Restricted mean survival time for the TLF	Restricted mean survival time for the TLF over 1 and 3 years	1 and 3 years