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GENOSS Coronary Stent Clinical Trial

NCT05444452 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 850

Last updated 2022-07-06

No results posted yet for this study

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

Interventions

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

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

Sponsors & Collaborators

  • Genoss Company Limited, Suwon, Korea

    collaborator UNKNOWN

  • Samsung Medical Center

    lead OTHER

Principal Investigators

  • Hyeon-Cheol Hyeon-Cheol, MD, PhD · Samsung Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-24
Primary Completion
2027-06-30
Completion
2027-06-30
FDA Device
Yes

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05444452 on ClinicalTrials.gov