NCT06086496Enrolling by invitation
Effectiveness and Safety of Abluminal Biodegradable Polymer Sirolimus-eluting Stent (GENOSS® DES)
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)
Source: ClinicalTrials.gov · Last updated 6 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
In this study, the investigators evaluated the effectiveness and safety of using the GENOSS® DES, which has a biodegradable polymer only on the inner wall of the blood vessel, for patients(all-comers) with coronary artery disease who require percutaneous coronary intervention through stent insertion.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 1000 (estimated)
- First submitted
- 4 Oct 2023
- Start date
- 15 Jul 2022
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Genoss Co., Ltd.
- Diseases
- Coronary artery disease
- NCT number
- NCT06086496
What you commit to
- Study type: Observational
- Planned participants: 1000
- From 15 Jul 2022 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- \<Inclusion Criteria\>
- Adults over 19 years of age
- Patients with typical symptoms or objective evidence of myocardial ischemia and eligible for coronary angioplasty.
- Severe coronary artery stenosis suitable for GENOSS® DES insertion
- 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\>
- 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)
- Patients who also received other drug-eluting stents
- If you have a disease with a remaining life expectancy of less than 1 year
- Pregnant or lactating women or women who may be pregnant
- 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.
- Patients judged by researchers to be unsuitable for research
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Korea University Anam Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.