GENOSS Coronary Stent Clinical Trial

NCT05444452 | Recruiting FDA Device

• 1 other identifier: GENOSS
• Study Type: interventional
• Target: 850
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Heart Disease

Keywords

coronary stent; ischemic heart disease; acute coronary syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• TLF at 3 years

  3 years

• Target vessel failure

  1 and 3 years

• All-cause death

  1 and 3 years

• Cardiac death

  1 and 3 years

• MI

  1 and 3 years

Study Arms (2)

GENOSS stent arm

EXPERIMENTAL

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

XIENCE stent arm

ACTIVE COMPARATOR

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

Interventions

Implanatation of Genoss DES sirolimus-eluting coronary system 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

GENOSS stent arm

Implanatation of Xience DES everolimus-eluting coronary system 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

XIENCE stent arm

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Samsung Medical Center: lead
• Genoss Company Limited, Suwon, Korea: collaborator

Study Sites (1)

Cardiac and Vascular Center; Samsung Medical Center

Seoul, 135-710, South Korea

RECRUITING

MeSH Terms

Conditions

Myocardial Ischemia; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Hyeon-Cheol Hyeon-Cheol, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyeon-Cheol Gwon, MD, PhD

CONTACT

82-2-3410-3694; hcgwon@naver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 6, 2022
• Study Start: April 24, 2022
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 6, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)