Efficacy and Safety of Short Duration of DAPT After GENOSS® DES Implantation in Patients with Coronary Artery Disease
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 short duration of DAPT after GENOSS® DES Implantation in patients with coronary artery disease.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 groupGroup 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 procedureSecondary 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 procedure2
All-cause deaths
Time frame
at 12 months after the procedure3
Cardiac death
Time frame
at 12 months after the procedure4
Non-cardiac death
Time frame
at 12 months after the procedureSponsors and contacts
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Source ClinicalTrials.gov