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 (DAPTLong)

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.

Study Overview

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

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 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
    • Wŏnju, 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 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

GENOSS Sirolimus Eluting Coronary Stent System; Patients with coronary artery disease treated with the GENOSS DES <Definition of a complex high-risk patients>; Clinical factorsAge 75 or olderHistory 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 dialysisHistory of strokeHistory of coronary artery bypass graftLeft ventricular dysfunction (LVEF <40%)Severe valve diseaseAcute coronary syndrome with positive troponin levels; Lesion/procedure factorsLeft main lesionChronic total occlusionBifurcation lesion with branches larger than 2 mmCalcified lesion (moderate to severe calcified lesion)Restenosis lesion (in-stent restenosis)Multivessel PCIThree 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-oriented composite endpoint	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		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
Any revascularization		at 12 months after the procedure
Target vessel-realted myocardial infarction (TV-MI)		at 12 months after the procedure
Revascularization of clinically appropriate target lesions		at 12 months after the procedure
Stent thrombosis by ARC definition		at 12 months after the procedure
Lesion success	When the final residual lesion stenosis is less than 30% using any surgical method.	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.	immediately after the procedure

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): May 13, 2022
• 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: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: CIP-DS0501-14

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