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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorGenoss Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Patients with coronary artery disease treated with GENOSS DES

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,000 Participants
are grouped into 1 trial group
Group A: GENOSS Sirolimus Eluting Coronary Stent System

Trial outcomes

Primary outcomes

1

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).

Time frame
at 12 months after the procedure

Secondary outcomes

1

Patient-oriented composite endpoint

POCE is defined as a composite of all-cause death, any myocardial infarction, and any revascularization.

Time frame
at 12 months after the procedure
2

All-cause deaths

Time frame
at 12 months after the procedure
3

Cardiac death

Time frame
at 12 months after the procedure
4

Non-cardiac death

Time frame
at 12 months after the procedure

Other outcomes

Sponsors and contacts

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