Evaluating Efficacy and Safety of Short Duration of DAPT After Genoss DES Stent Implantation in Patients (DAPTShort)

Prospective Multicenter Observational Study for Evaluating Efficacy and Safety of Short Duration of Dual Antiplatelet Therapy After Genoss DES Sirolimus-eluting Stent Implantation in Patients With Coronary Artery Disease

The investigators aimed to evaluate the safety and effectiveness of short-term DAPT (3 months for SCAD, 6 months for ACS) after PCI with Genoss DES in patients with coronary artery disease.

Study Overview

• Status: Recruiting
• Conditions: Acute Coronary Syndrome; Percutaneous Coronary Intervention; Dual Antiplatelet Therapy
• Intervention / Treatment: Device: Genoss DES stent

Detailed Description

This study is a sponsor-initiated clinical trial (SIT) that enrolls patients with coronary artery disease who have undergone percutaneous coronary intervention using the GENOSS DES stent as research subjects, collects data on the patients' clinical and surgical procedures, and reports on clinical events. The investigators will track the outbreak.

This study is a prospective, multicenter registration observational study that will enroll patients with coronary artery disease who underwent percutaneous coronary intervention with GENOSS DES at a total of five institutions.

This study is a registered observation study and does not separately calculate the number of subjects, but plans to recruit a total of 1,000 subjects during the study period.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: YoungJin Youn; Phone Number: 033-741-0910; Email: younyj@yonsei.ac.kr

Study Locations

• Korea, Republic of
  • Gangwon State
    • Wonju, Gangwon State, Korea, Republic of
      • Recruiting
      • Wonju Severance Christian Hospital
      • Contact: Young Jin Youn; Phone Number: 033-741-0910; Email: younyj@yonsei.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients receiving coronary artery disease treatment using Genoss DES stent

Description

Inclusion Criteria:

1. Adults aged 19 or older
2. 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:

1. Psychogenic shock at the time of hospitalization
2. Expecting to become pregnant, pregnant or lactating woman
3. 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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
device-oriented composite end point	cardiac death, any myocardial infarction not clearly attributable to a nontarget vessel, clinically indicated target-lesion revascularization	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient-oriented composite end point	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.	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness evaluation	All reperfusions at 12 months; Reperfusion of clinically appropriate target lesions at 12 months	12 months
Safety evaluation	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

• Sponsor: Genoss Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2021
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

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): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 16, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Acute Coronary Syndrome
• Other Study ID Numbers: CR221004

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