Clinical trial NCT06066476: Efficacy and Safety of GENOSS® DES in Patients with Coronary Artery Disease
Official title: A Prospective, Multicenter, Observational Study to Evaluate the Efficacy and Safety of GENOSS DES in Patients with Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: Genoss Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-10-04
Enrollment: 1022
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 this study is to evaluate the efficacy and safety of the GENOSS DES in patients with coronary artery disease in real-world pratice.

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 the Genoss DES in all-comer patients undergoing percutaneous coronary intervention.

The Genoss DES registry is a prospective, single-arm, observational study for evaluation of clinical outcomes after Genoss DES implantation in all-comer patients undergoing percutaneous coronary intervention from 12 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.

Eligibility criteria: \<Inclusion Criteria\>

1. Patients of 19 and over
2. Patients eligible for treatment of coronary artery disease using GENOSSTM DES
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 research participants.

\<Exclusion Criteria\>

1. Patients who are contraindicated in the use of heparin, aspirin, clopidogrel, sirolimus, cobalt chromium and contrast agents (However, patients with hypersensitivity to contrast agents may be eligible if it can be controlled by steroids and pheniramine. Patients with known anaphylaxis are excluded)
2. Patients who are pregnant or planning to become pregnant
3. Patients scheduled to undergo surgery requiring the discontinuation of antiplatelet agents within 12 months from registration
4. Patients with a life expectancy of less than 1 year
5. Patients who presented with cardiogenic shock at admission and are predicted to have a low chance of survival based on medical judgment
6. Patients who have already received treatment with another DES (Drug Eluting Stent), BVS (Bioresorbable Vascular Scaffolds), or BMS (Bare Metal Stent) at the time of registration
7. Patients currently participating in a randomized controlled trial involving medical devices

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-related myocardial infarction (TV-MI)
timeFrame: at 12 months after the procedure
measure: Any revascularization
timeFrame: at 12 months after the procedure
measure: Clinically indicated target lesion revascularization (TLR)
timeFrame: at 12 months after the procedure
measure: Stent thrombosis
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: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
References: