DAPTLONG: Evaluating Efficacy and Safety of 1-year of DAPT After Genoss DES™ Sirolimus-eluting Stent Implantation in Patients
Study Details
Study Description
Brief Summary
In this prospective, multicenter observational study, we evaluated the safety and effectiveness of DAPT over 1 year in all patients with coronary artery disease, including patients with complex high-risk coronary artery disease (CHIP), who underwent PCI using the Genoss DES™ stent, and performed subgroup analysis. Through this, we aim to determine whether there are differences in safety and effectiveness depending on whether or not the patient is a subject with complex high-risk coronary artery disease.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
This study is a sponsor-initiated clinical trial (SIT) that enrolls patients with coronary artery disease who underwent PCI using the GENOSS DES drug-eluting stent as research subjects, collects data on Honaza's clinical practice and procedures, and determines the occurrence of clinical events. We will track this.
This study is a prospective, multicenter study enrolling patients with coronary artery disease who underwent percutaneous coronary intervention with GENOSS DES. A total of eight institutions will recruit subjects.
This study is a registered observation study and does not calculate a separate number of subjects, but plans to recruit a total of 1,000 subjects during the study registration period.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| complex coronary artery disease <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 surgery Left ventricular dysfunction (LVEF <40%) Severe valve disease Troponin positive acute coronary syndrome <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 (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) |
Device: Genoss DES™ stent
The Genoss DES (Genoss, Korea) L-605 cobalt chromium (CoCr) platform with a strut thickness of 70 µm Sirolimus drug with concentration of 1.15µg/mm2 Abluminal biodegradable PLA and PLGA polymers.
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Outcome Measures
Primary Outcome Measures
- device-oriented composite end point [12 months]
cardiac death, any myocardial infarction not clearly attributable to a nontarget vessel, clinically indicated target-lesion revascularization
Secondary Outcome Measures
- patient-oriented composite end point [12 months]
all-cause mortality, any myocardial infarction, any revascularization 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 All reperfusions at 12 months Reperfusion of clinically appropriate target lesions at 12 months Stent thrombosis by ARC definition at 12 months Lesion success during the procedure: When the final remaining lesion stenosis is less than 30% using any surgical method. Procedure success: When the final residual lesion stenosis is less than 30% using any surgical method, and there is no death, myocardial infarction, or reperfusion after the procedure during the hospitalization period.
Other Outcome Measures
- Safety evaluation [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
- Effectiveness evaluation [12 months]
All reperfusions at 12 months Reperfusion of clinically appropriate target lesions at 12 months
Eligibility Criteria
Criteria
Inclusion Criteria:
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① Adults aged 19 or older
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Subjects treated for coronary artery disease using the Genoss DES™ stent ③ Subjects who agree to the research protocol and clinical follow-up plan, voluntarily decide to participate in this clinical study, and provide written consent in the research subject consent form.
Exclusion Criteria:
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① Psychogenic shock at the time of hospitalization
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Expecting to become pregnant, pregnant or lactating woman
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In cases where the remaining survival period is expected to be less than 1 year due to a concomitant medical disease ④ Subjects participating in other medical device randomization studies ⑤ Subjects who received treatment using a different DES or BMS at the time of registration (however, due to failure of Genoss DES™ stent insertion, insertion of other stents is allowed)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Wonju Severance Christian Hospital | Wŏnju | Gangwon State | Korea, Republic of |
Sponsors and Collaborators
- Genoss Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR221008