Evaluating the safety and effectiveness of Genoss stents in patients with multivessel coronary artery disease
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)
This study is testing how safe and effective Genoss drug-eluting stents are for people with multivessel coronary artery disease who have received this treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Genoss Co., Ltd. Industry-sponsored |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06168305 on ClinicalTrials.gov |
What this trial studies
This observational study aims to enroll and track patients with multivessel coronary artery disease who have undergone treatment using Genoss drug-eluting stents (DES). The study will collect data on clinical and surgical processes, as well as monitor the occurrence of clinical events over time. A total of 1,000 participants will be recruited from multiple centers, focusing on the efficacy and safety of the Genoss DES in this patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 19 years and older with multivessel coronary artery disease who have undergone percutaneous coronary intervention with Genoss stents.
Not a fit: Patients with known hypersensitivity or contraindications to essential medications or contrast agents may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and effectiveness of Genoss stents, potentially improving treatment options for patients with multivessel coronary artery disease.
How similar studies have performed: While this study focuses on a specific device, similar observational studies have shown success in evaluating the safety and effectiveness of drug-eluting stents in coronary artery disease.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Seoul
- Korea University GURO Hospital — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: SeungWoon Rha
- Email: swrha617@yahoo.co.kr
- Phone: 010-8721-0459
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.