NCT06075368

Brief Summary

The objective of this study is to evaluate the efficacy and safety of the GENOSS SES in patients with acute coronary syndrome (ACS) in real-world pratice.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
757

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Mar 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Mar 2020Dec 2027

Study Start

First participant enrolled

March 16, 2020

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Expected
Last Updated

February 11, 2026

Status Verified

February 1, 2025

Enrollment Period

5.8 years

First QC Date

October 4, 2023

Last Update Submit

February 9, 2026

Conditions

Acute Coronary SyndromePercutaneous Coronary Intervention

Keywords

ACS

Outcome Measures

Primary Outcomes (1)

  • Device-oriented composite endpoint

    DOCE is defined as a composite of cardiac death, target vessel-related myocardial infarction (TV-MI) and clinically indicated target-lesion revascularization (TLR).

    12 months after the procedure

Secondary Outcomes (9)

  • Target lesion failure (TLF)

    3 years after the procedure

  • Target vessel failure (TVF)

    3 years after the procedure

  • All-cause death

    3 years after the procedure

  • Cardiac death

    3 years after the procedure

  • All-cause death and any myocardial infarction

    3 years after the procedure

  • +4 more secondary outcomes

Other Outcomes (1)

  • Safety evaluation

    1 month, 12 months, 2 years, 3 years after the procedure

Study Arms (1)

GENOSS® DES Sirolimus Eluting Coronary Stent System / B03300.20, class [4]

Patients with acute coronary syndrome treated with the GENOSS SES

Device: GENOSS Sirolimus Eluting Coronary Stent System

Interventions

GENOSS Sirolimus Eluting Coronary Stent SystemDEVICE

The GENOSS SES is a novel, biodegradable, polymer-coated, sirolimus-eluting stent with a cobalt chromium stent platform and thin strut.

GENOSS® DES Sirolimus Eluting Coronary Stent System / B03300.20, class [4]

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with acute coronary syndrome treated with the GENOSS SES

You may qualify if:

  • Patients of 19 and over
  • Patients with acute coronary syndrome treated with GENOSS SES
  • Participants who voluntarily decide to participate in this clinical trial, agree to the study protocol and clinical follow-up plan, and provide written informed consent as study participants.

You may not qualify if:

  • Patients who are contraindicated in the use of heparin, aspirin, clopidogrel, sirolimus, cobalt chromium and contrast agents
  • \- However, patients with hypersensitivity to contrast agents may be eligible if it can be controlled by steroids and pheniramine. Patients with known anaphylaxis are excluded
  • Patients who are pregnant or planning to become pregnant
  • Patients scheduled to undergo surgery requiring the discontinuation of antiplatelet agents within 12 months from registration.
  • Patients with a life expectancy of less than 1 year
  • Patients who presented with cardiogenic shock at admission and are predicted to have a low chance of survival based on medical judgment.
  • Patients who have already received treatment with another DES (Drug Eluting Stent), BVS (Bioresorbable Vascular Scaffolds), or BMS (Bare Metal Stent) at the time of registration.
  • Patients currently participating in a randomized controlled trial involving medical devices.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2023

First Posted

October 10, 2023

Study Start

March 16, 2020

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2027

Last Updated

February 11, 2026

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)