Efficacy and Safety of Short Duration of DAPT After GENOSS® DES Implantation in Patients with Coronary Artery Disease
DAPTShort
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
1 other identifier
observational
1,000
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2021
Longer than P75 for all trials
1 active site
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 Start
First participant enrolled
August 18, 2021
CompletedFirst Submitted
Initial submission to the registry
October 4, 2023
CompletedFirst Posted
Study publicly available on registry
October 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
February 21, 2025
February 1, 2025
6.4 years
October 4, 2023
February 18, 2025
Conditions
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).
at 12 months after the procedure
Secondary Outcomes (11)
Patient-oriented composite endpoint
at 12 months after the procedure
All-cause deaths
at 12 months after the procedure
Cardiac death
at 12 months after the procedure
Non-cardiac death
at 12 months after the procedure
Any myocardial infarction
at 12 months after the procedure
- +6 more secondary outcomes
Study Arms (1)
GENOSS Sirolimus Eluting Coronary Stent System
Patients with coronary artery disease treated with the GENOSS DES
Eligibility Criteria
Patients with coronary artery disease treated with GENOSS DES
You may qualify if:
- Patients of 19 and over
- Patients with coronary artery disease 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 with cardiogenic shock at the time of hospitalization
- Patients who are pregnant or planning to become pregnant
- Patients with a life expectancy of less than 1 year
- Patients participating in randomized controlled trials using other medical devices
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genoss Co., Ltd.lead
Study Sites (1)
Wonju Severance Christian Hospital
Wŏnju, Gangwon State, South Korea
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2023
First Posted
October 10, 2023
Study Start
August 18, 2021
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
February 21, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share