Clinical trial NCT06075368: Efficacy and Safety of GENOSS® SES in Patients with Acute Coronary Syndrome (GENOSS ACS)
Official title: A Prospective, Multicenter, Observational Study to Evaluate the Efficacy and Safety of GENOSS SES in Patients with Acute Coronary Syndrome
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Acute Coronary Syndrome
Percutaneous Coronary Intervention
Keywords: ACS
Lead sponsor: Genoss Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-10-10
Enrollment: 757
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 acute coronary syndrome treated with the GENOSS SES

Brief summary: The objective of this study is to evaluate the efficacy and safety of the GENOSS SES in patients with acute coronary syndrome (ACS) in real-world pratice.

Detailed description: The Genoss SES 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 SES in acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention.

The Genoss SES study is a prospective, single-arm, observational study for evaluation of clinical outcomes after Genoss SES implantation in ACS patients undergoing percutaneous coronary intervention from 10 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 10 months.

Eligibility criteria: \<Inclusion Criteria\>

1. Patients of 19 and over
2. Patients with acute coronary syndrome 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 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: 12 months after the procedure
Secondary outcomes:
measure: Target lesion failure (TLF)
timeFrame: 3 years after the procedure
measure: Target vessel failure (TVF)
timeFrame: 3 years after the procedure
measure: All-cause death
timeFrame: 3 years after the procedure
measure: Cardiac death
timeFrame: 3 years after the procedure
measure: All-cause death and any myocardial infarction
timeFrame: 3 years after the procedure
measure: Cardiac death and target vessel-related myocardial infarction
timeFrame: 3 years after the procedure
measure: Target vessel revascularization (TVR)
timeFrame: 3 years after the procedure
measure: Target lesion revascularization (TLR)
timeFrame: 3 years after the procedure
measure: Stent thrombosis
timeFrame: 3 years after the procedure
Other outcomes:
measure: Safety evaluation
timeFrame: 1 month, 12 months, 2 years, 3 years after the procedure
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
References: