Efficacy and Safety of Short Duration of DAPT After GENOSS® DES Implantation in Patients with Coronary Artery Disease (DAPTShort)

February 18, 2025 updated by: Genoss Co., Ltd.

A Prospective, Multicenter, Observational Study to Evaluate the Efficacy and Safety of Short Duration of DAPT After GENOSS® DES Implantation in Patients with Coronary Artery Disease

The objective of study is to evaluate the efficacy and safety of short duration of DAPT after GENOSS® DES Implantation in patients with coronary artery disease.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The Genoss DES is a novel, biodegradable, polymer-coated, sirolimus eluting stent with a cobalt-chromium stent platform and thin strut. Although the efficacy and safety of this stent have been previously investigated, real-world clinical outcomes data are lacking. Therefore, the objective of this prospective, multicenter study was to evaluate the clinical efficacy and safety of short duration of DAPT after GENOSS® DES Implantation in patients with coronary artery disease.

The Genoss DES registry is a prospective, single-arm, observational study for evaluation of clinical outcomes of short duration of DAPT (3 months for SCAD, 6 months for ACS) after Genoss DES implantation in patients with coronary artery disease from 6 sites in South Korea. The primary endpoint was a device-oriented composite endpoint (DOCE), defined as a composite of cardiac death, target vessel-related myocardial infarction (MI), and clinically indicated target lesion revascularization (TLR) at 12 months. The key secondary endpoint was a patient-oriented composite endpoint (POCE), defined as a composite of all-cause death, any myocardial infarction, and any revascularization at 12 months.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
    • Gangwon state
      • Wonju, Gangwon state, Korea, Republic of
        • Recruiting
        • Wonju Severance Christian Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with coronary artery disease treated with GENOSS DES

Description

Inclusion Criteria:

  1. Patients of 19 and over
  2. Patients with coronary artery disease treated with GENOSS SES
  3. 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

Exclusion Criteria:

  1. Patients with cardiogenic shock at the time of hospitalization
  2. Patients who are pregnant or planning to become pregnant
  3. Patients with a life expectancy of less than 1 year
  4. Patients participating in randomized controlled trials using other medical devices
  5. Patients who have already received treatment with another DES (Drug Eluting Stent) or BMS (Bare Metal Stent) at the time of registration (However, other stent insertions are allowed due to failure of GENOSS DES insertion)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
GENOSS Sirolimus Eluting Coronary Stent System
Patients with coronary artery disease treated with the GENOSS DES

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device-oriented composite endpoint
Time Frame: at 12 months after the procedure
DOCE is defined as a composite of cardiac death, target vessel-related myocardial infarction (TV-MI) and clinically indicated target-lesion revascularization (TLR).
at 12 months after the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-oriented composite endpoint
Time Frame: at 12 months after the procedure
POCE is defined as a composite of all-cause death, any myocardial infarction, and any revascularization.
at 12 months after the procedure
All-cause deaths
Time Frame: at 12 months after the procedure
at 12 months after the procedure
Cardiac death
Time Frame: at 12 months after the procedure
at 12 months after the procedure
Non-cardiac death
Time Frame: at 12 months after the procedure
at 12 months after the procedure
Any myocardial infarction
Time Frame: at 12 months after the procedure
at 12 months after the procedure
Any revascularization
Time Frame: at 12 months after the procedure
at 12 months after the procedure
Clinically indicated target lesion revascularization (TLR)
Time Frame: at 12 months after the procedure
at 12 months after the procedure
Target vessel-realted myocardial infarction (TV-MI)
Time Frame: at 12 months after the procedure
at 12 months after the procedure
Stent thrombosis by ARC definition
Time Frame: at 12 months after the procedure
at 12 months after the procedure
Lesion success
Time Frame: during the procedure
When the final residual lesion stenosis is less than 30% using any surgical method.
during the procedure
Procedure success
Time Frame: immediately after the procedure
When the final residual lesion stenosis is less than 30% using any surgical method, and there is no post-procedure death, myocardial infarction, or revascularization during the hospitalization period
immediately after the procedure

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness evaluation
Time Frame: 12 months
  • All reperfusions at 12 months
  • Reperfusion of clinically appropriate target lesions at 12 months
12 months
Safety evaluation
Time Frame: 12 months
  • All deaths at 12 months
  • Psychogenic death at 12 months
  • Non-cardiac death at 12 months
  • All myocardial infarctions at 12 months
  • All myocardial infarctions that are not clearly related to non-target vessels at 12 months
  • Standardized bleeding criteria at 12 months (Bleeding Academic Research Consortium; see appendix) type 2 to 5 bleeding
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genoss Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 18, 2021

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

October 4, 2023

First Submitted That Met QC Criteria

October 4, 2023

First Posted (Actual)

October 10, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 18, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP-DS0501-13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No The data set is available from the the corresponding author upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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