Clinical trial NCT06168305: Safety and Effectiveness of GENOSS DES in Patients With Multivessel Coronary Artery Disease
Official title: Safety and Effectiveness of GENOSS DES (Sirolimus-eluting Coronary Stent System) in Patients With Multivessel Coronary Artery Disease (MVCAD): A Multicenter, Prospective, Observational Study (GENOSS-MV)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Percutaneous Coronary Intervention
Multivessel Coronary Artery Disease
Lead sponsor: Genoss Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-12-13
Enrollment: 1000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Multivessel coronary artery disease treated with percutaneous coronary intervention using GENOSS stent.

Brief summary: The investigators intend to establish a multicenter prospective observational study by enrolling and tracking patients with multivessel coronary artery disease (MVCAD) using Genoss DES, a device manufactured with pure domestic technology. The study aims to evaluate the efficacy and safety of Genoss DES in MVCAD patients.

Detailed description: This study is a sponsor-driven clinical trial (SIT) that aims to enroll patients who have undergone treatment for multivessel coronary artery disease using Genoss stents. The study involves collecting data on the clinical and surgical processes of patients and tracking the occurrence of clinical events.

This prospective, multicenter observational study registers patients with acute coronary artery disease who have been treated with GENOSS stents at a total of 8 institutions.

As it is an observational study, the number of subjects is not separately calculated, but the plan is to recruit a total of 1,000 participants during the study registration period.

Eligibility criteria: Inclusion Criteria:

* Adults aged 19 years and older
* Individuals with multivessel coronary artery disiease(MVCAD), including those with recurrent lesions at the procedure site, such as neo-atherosclerotic lesions.
* Participants who have undergone percutanoeus coronary intervention (PCI) with genoss stnets
* Participants who have agreed to the trial protocol and clinical follow-up plan, have voluntarily decided to participate in this clinical trial, and have provided written consent in the informed consent form for trial participation. (Note: Foreign participants must be fluent in Korean and capable of understanding Korean documents, including the informed consent form, to be included.

Exclusion Criteria:

* Trial participants with known hypersensitivity or contraindications to the following drugs or substances: Heparin, Aspirin, Clopidogrel, Cilostazol, Contrast agents (Note: Even participants with hypersensitivity to contrast agents may be eligible for enrollment if their sensitivity can be controlled by steroids and antihistamines; however, those with known anaphylaxis are excluded).
* Cases where balloon expansion is unsuccessful during balloon angioplasty at the stenotic site.
* Participants with an expected residual lifespan of less than one year.
* Those who are planning to become pregnant, pregnant, or breastfeeding.
* Participants who presented with cardiogenic shock during hospitalization and are predicted to have a low likelihood of survival based on medical judgment.
* Individuals deemed unsuitable for this clinical trial or those for whom participation may increase risks related to trial involvement, as determined by the investigator.
* Foreign participants who cannot fluently speak Korean and have difficulty understanding Korean documents.

Primary outcomes:
measure: device-oriented composite end point
timeFrame: 12 months
Secondary outcomes:
measure: Number of participants with patient-oriented composite endpoint
timeFrame: 12 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University GURO Hospital
Study officials:
References: