Evaluating a new biodegradable stent for coronary artery disease
Evaluation of Effectiveness and Safety of Abluminal Biodegradable Polymer Sirolimus-eluting Stent in Routine Clinical Practice: A Prospective, Single-arm, Multicenter, Observational Study (The GENCOMX Registry)
Genoss Co., Ltd. · NCT06086496
This study is testing a new biodegradable heart stent to see if it helps people with severe coronary artery disease feel better after their procedure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Genoss Co., Ltd. (industry) |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06086496 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effectiveness and safety of the GENOSS biodegradable polymer sirolimus-eluting stent in patients with coronary artery disease requiring percutaneous coronary intervention. Approximately 1,000 patients will be enrolled across seven institutions, focusing on those who have severe coronary artery stenosis suitable for this specific stent. The study will collect real-world data on patient outcomes following stent insertion, providing insights into its performance in a clinical setting.
Who should consider this trial
Good fit: Ideal candidates include adults over 19 years with symptoms of myocardial ischemia and severe coronary artery stenosis eligible for stent insertion.
Not a fit: Patients with known hypersensitivity to the stent materials or those who have received other drug-eluting stents may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with coronary artery disease, potentially enhancing safety and effectiveness of stent procedures.
How similar studies have performed: While this approach is being evaluated in this specific context, similar biodegradable stent technologies have shown promise in other studies, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adults over 19 years of age 2. Patients with typical symptoms or objective evidence of myocardial ischemia and eligible for coronary angioplasty. 3. Severe coronary artery stenosis suitable for Genoss stent insertion 4. Patients who agree to the research protocol and clinical follow-up plan and give written informed consent in the consent form approved by the Institutional Review Board/Ethics Committee of each research institution. Exclusion Criteria: 1. Test subjects with known hypersensitivity or contraindications to the following drugs or substances: heparin, aspirin, clopidogrel, sirolimus, contrast medium (however, even subjects with hypersensitivity to contrast medium can be controlled by steroids and pheniramine) In this case, registration is possible, but if there is known anaphylaxis, it is excluded) 2. Patients who also received other drug-eluting stents 3. If you have a disease with a remaining life expectancy of less than 1 year 4. Pregnant or lactating women or women who may be pregnant 5. Cases in which the patient was admitted to the hospital due to psychogenic shock and the likelihood of survival is medically expected to be low. 6. Patients judged by researchers to be unsuitable for research
Where this trial is running
Seoul
- Korea University Anam Hospital — Seoul, Korea, Republic of (RECRUITING)
Study contacts
- Study coordinator: Cheol Woong Yu
- Email: ycw717@naver.com
- Phone: 02-920-5445
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.
Conditions: Coronary Artery Disease, Percutaneous Coronary Intervention