Wonju Severance Christian Hospital
Wŏnju, Gangwon State, South Korea
Location status: Recruiting
NCT Number: NCT06075420
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.
Interested in participating?
Request Info19 year and older
All sexes
Observational
Wŏnju, Gangwon State, South Korea
Location status: Recruiting
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 short duration of DAPT after GENOSS® DES Implantation in patients with coronary artery disease.
The Genoss DES registry is a prospective, single-arm, observational study for evaluation of clinical outcomes of short duration of DAPT (3 months for SCAD, 6 months for ACS) after Genoss DES implantation in patients with coronary artery disease from 6 sites in South Korea. The primary endpoint was a device-oriented 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: at 12 months after the procedure
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
POCE is defined as a composite of all-cause death, any myocardial infarction, and any revascularization.
Time frame: at 12 months after the procedure
Time frame: at 12 months after the procedure
Time frame: at 12 months after the procedure
Time frame: at 12 months after the procedure
Time frame: at 12 months after the procedure
Time frame: at 12 months after the procedure
Time frame: at 12 months after the procedure
Time frame: at 12 months after the procedure
Time frame: during the procedure
When the final residual lesion stenosis is less than 30% using any surgical method.
Time frame: immediately after the procedure
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
Contact information is provided by the study sponsor or research team.
Genoss Co., Ltd.
Industry
A Prospective, Multicenter, Observational Study to Evaluate the Efficacy and Safety of Short Duration of DAPT After GENOSS® DES Implantation in Patients with Coronary Artery Disease
Acronym: DAPTShort
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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