Coronary Artery DiseaseDAPTLongNCT06075433
Efficacy and Safety of 1-year Duration of DAPT After GENOSS® DES Implantation in Patients with Coronary Artery Disease According to the Complex Higher-risk Procedure
An observational study of Coronary Artery Disease and Percutaneous Coronary Intervention, run by Genoss Co., Ltd. at 1 site in South Korea.
Trial summary
The objective of study is to evaluate the efficacy and safety of 1 year duration of DAPT after GENOSS® DES Implantation in patients with coronary artery disease according to the complex higher-risk (and indicated) procedure. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease, Percutaneous Coronary Intervention, Dual Antiplatelet Therapy
- How many people
- 1,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 May 2022to 31 Dec 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with coronary artery disease treated with GENOSS DES
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Wonju Severance Christian Hospital
Wŏnju, Gangwon State
Young Jin youn, 033-741-0910, younyj@yonsei.ac.kr
About this study
Official title: A Prospective, Multicenter, Observational Study to Evaluate the Efficacy and Safety of 1 Year Duration of DAPT After GENOSS® DES Implantation in Patients with Coronary Artery Disease According to the Complex Higher-Risk Procedure
The objective of study is to evaluate the efficacy and safety of 1 year duration of DAPT after GENOSS® DES Implantation in patients with coronary artery disease according to the complex higher-risk (and indicated) procedure.
Read the 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 1 year duration of DAPT after GENOSS® DES Implantation in patients with coronary artery disease according to the complex higher-risk (and indicated) procedure.
The Genoss DES registry is a prospective, single-arm, observational study for evaluation of clinical outcomes of 1 year duration of DAPT after Genoss DES implantation in patients with coronary artery disease according to the complex higher-risk (and indicated) procedure from 9 sites in South Korea. The primary endpoint was a deviceoriented 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.
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| GENOSS Sirolimus Eluting Coronary Stent System | Patients with coronary artery disease treated with the GENOSS DES <Definition of a complex high-risk patients> 1. Clinical factors * Age 75 or older * History of diabetes (those who have had diabetes in the past or are taking diabetes medication) * History of chronic kidney disease (GFR <60ml/min/1.73m2) or dialysis * History of stroke * History of coronary artery bypass graft * Left ventricular dysfunction (LVEF <40%) * Severe valve disease * Acute coronary syndrome with positive troponin levels 2. Lesion/procedure factors * Left main lesion * Chronic total occlusion * Bifurcation lesion with branches larger than 2 mm * Calcified lesion (moderate to severe calcified lesion) * Restenosis lesion (in-stent restenosis) * Multivessel PCI * Three or more stents implanted (≥3 stents implanted) * When the stent length of one lesion is more than 50 mm (total stent length >50 mm in a lesion) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: at 12 months after the procedure
Secondary outcomes (11)
Patient-oriented composite endpoint
POCE is defined as a composite of all-cause death, any myocardial infarction, and any revascularization.
Measured: at 12 months after the procedure
All-cause deaths
Measured: at 12 months after the procedure
Cardiac death
Measured: at 12 months after the procedure
Non-cardiac death
Measured: at 12 months after the procedure
Any myocardial infarction
Measured: at 12 months after the procedure
Target vessel-realted myocardial infarction (TV-MI)
Measured: at 12 months after the procedure
Any revascularization
Measured: at 12 months after the procedure
Revascularization of clinically appropriate target lesions
Measured: at 12 months after the procedure
Stent thrombosis by ARC definition
Measured: at 12 months after the procedure
Lesion success
When the final residual lesion stenosis is less than 30% using any surgical method.
Measured: during the procedure
Procedure success
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.
Measured: immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start13 May 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Genoss Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Genoss Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06075433
- Sponsor's protocol ID
- CIP-DS0501-14
- Acronym
- DAPTLong
- Status last verified
- Feb 2025
- First submitted
- 4 Oct 2023
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No The data set is available from the the corresponding author upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Observational Study to Evaluate the Efficacy and Safety of 1 Year Duration of DAPT After GENOSS® DES Implantation in Patients with Coronary Artery Disease According to the Complex Higher-Risk Procedure
- ClinicalTrials.gov ID
- NCT06075433
- Acronym / sponsor ID
- DAPTLong / CIP-DS0501-14
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Genoss Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 May 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of study is to evaluate the efficacy and safety of 1 year duration of DAPT after GENOSS® DES Implantation in patients with coronary artery disease according to the complex higher-risk (and indicated) procedure.
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 1 year duration of DAPT after GENOSS® DES Implantation in patients with coronary artery disease according to the complex higher-risk (and indicated) procedure.
The Genoss DES registry is a prospective, single-arm, observational study for evaluation of clinical outcomes of 1 year duration of DAPT after Genoss DES implantation in patients with coronary artery disease according to the complex higher-risk (and indicated) procedure from 9 sites in South Korea. The primary endpoint was a deviceoriented 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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GENOSS Sirolimus Eluting Coronary Stent System | – | –Patients with coronary artery disease treated with the GENOSS DES <Definition of a complex high-risk patients> 1. Clinical factors * Age 75 or older * History of diabetes (those who have had diabetes in the past or are taking diabetes medication) * History of chronic kidney disease (GFR <60ml/min/1.73m2) or dialysis * History of stroke * History of coronary artery bypass graft * Left ventricular dysfunction (LVEF <40%) * Severe valve disease * Acute coronary syndrome with positive troponin levels 2. Lesion/procedure factors * Left main lesion * Chronic total occlusion * Bifurcation lesion with branches larger than 2 mm * Calcified lesion (moderate to severe calcified lesion) * Restenosis lesion (in-stent restenosis) * Multivessel PCI * Three or more stents implanted (≥3 stents implanted) * When the stent length of one lesion is more than 50 mm (total stent length >50 mm in a lesion) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with coronary artery disease treated with GENOSS DES
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
11 secondary outcomes
Patient-oriented composite endpoint
Time frame: at 12 months after the procedure
All-cause deaths
Time frame: at 12 months after the procedure
Cardiac death
Time frame: at 12 months after the procedure
Non-cardiac death
Time frame: at 12 months after the procedure
Any myocardial infarction
Time frame: at 12 months after the procedure
Target vessel-realted myocardial infarction (TV-MI)
Time frame: at 12 months after the procedure
Any revascularization
Time frame: at 12 months after the procedure
Revascularization of clinically appropriate target lesions
Time frame: at 12 months after the procedure
Stent thrombosis by ARC definition
Time frame: at 12 months after the procedure
Lesion success
Time frame: during the procedure
Procedure success
Time frame: immediately after the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Individual participant dataSharing planned: No. No The data set is available from the the corresponding author upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Percutaneous Coronary Intervention, run by Genoss Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact YoungJin Youn (033-741-0910, younyj@yonsei.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device-oriented composite endpoint (time frame: at 12 months after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.