Clinical trial NCT06075433: 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
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Percutaneous Coronary Intervention
Dual Antiplatelet Therapy
Lead sponsor: Genoss Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-10-10
Enrollment: 1000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with coronary artery disease treated with GENOSS DES

Brief 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Device-oriented composite endpoint
timeFrame: at 12 months after the procedure
Secondary outcomes:
measure: Patient-oriented composite endpoint
timeFrame: at 12 months after the procedure
measure: All-cause deaths
timeFrame: at 12 months after the procedure
measure: Cardiac death
timeFrame: at 12 months after the procedure
measure: Non-cardiac death
timeFrame: at 12 months after the procedure
measure: Any myocardial infarction
timeFrame: at 12 months after the procedure
measure: Target vessel-realted myocardial infarction (TV-MI)
timeFrame: at 12 months after the procedure
measure: Any revascularization
timeFrame: at 12 months after the procedure
measure: Revascularization of clinically appropriate target lesions
timeFrame: at 12 months after the procedure
measure: Stent thrombosis by ARC definition
timeFrame: at 12 months after the procedure
measure: Lesion success
timeFrame: during the procedure
measure: Procedure success
timeFrame: immediately after the procedure
Other outcomes:
Locations:
city: Wŏnju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
state: Gangwon state
Study officials:
References: