GENOSS Coronary Stent Clinical Trial

NCT ID: NCT05444452

Last Updated: 2022-07-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 850 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-24
• Study Completion Date: 2027-06-30

Brief 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.

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.

Conditions

Ischemic Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GENOSS stent arm

Coronary lesions of the subjects this arm will be treated with GENOSS stent when in need of stent implantation

Group Type: EXPERIMENTAL

Implanatation of Genoss DES sirolimus-eluting coronary system

Intervention Type: DEVICE

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

XIENCE stent arm

Coronary lesions of the subjects this arm will be treated with Xience stent when in need of stent implantation

Group Type: ACTIVE_COMPARATOR

Implanatation of Xience DES everolimus-eluting coronary system

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: 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

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genoss Company Limited, Suwon, Korea

UNKNOWN

Sponsor Role: collaborator

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hyeon-Cheol Hyeon-Cheol, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

Cardiac and Vascular Center; Samsung Medical Center

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Hyeon-Cheol Gwon, MD, PhD

Role: CONTACT

hcgwon@naver.com

82-2-3410-3694

Facility Contacts

Hyeon-Cheol Gwon, Professor

Role: primary

hc.gwon@samsung.com

82234103419

Other Identifiers

GENOSS

Identifier Type: -

Identifier Source: org_study_id