NCT06577896Recruiting
The Study to Evaluate the Safety and Efficacy of the Onyx Family
Safety and Efficacy of 1-month Dual Antiplatelet Therapy in High Bleeding and Ischemic Risk Elderly Patients With Coronary Artery Disease After Implantation of Zotarolimus-eluting Coronary Stent System (Onyx Family, Medtronic, Minneapolis, MN); A Multicenter, Prospective, Observational Study
Source: ClinicalTrials.gov · Last updated 19 Sept 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Observation of the safety and efficacy of 1-month dual antiplatelet therapy (DAPT) after percutaneous coronary intervention using Onyx family stents in elderly patients aged 75 years or older
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 500 (estimated)
- First submitted
- 27 Aug 2024
- Start date
- 9 Jun 2022
- Primary completion date
- 31 Jan 2026
- Lead sponsor
- Pusan National University Yangsan Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT06577896
What you commit to
- Study type: Observational
- Planned participants: 500
- From 9 Jun 2022 to the primary completion date, 31 Jan 2026
- 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.
Prior treatment
- The patient has a known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, zotarolimus, and contrast media (patients with documented sensitivity to contrast media which can be effectively premedicated with steroids and diphenhydramine \[eg, rash\] may be enrolled. Those with true anaphylaxis to prior contrast media, however, should not be enrolled).
- Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
- Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
Other illness
- Patients with active pathologic bleeding.
- History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia).
- Noncardiac comorbid conditions are present with life expectancy \<1 year or that may result in protocol noncompliance (per site investigator\'s medical judgment).
Who the study is looking for
- Aged 75 or more.
- Eligible for interventional procedures.
- Evidence of myocardial ischemia or coronary artery stenosis ≥ 50%.
- Able to take antiplatelets for at least 1 months after the procedure.
- Patients who underwent coronary artery procedures with ZES (Medtronic, Minneapolis, MN, Onyx™ family) stent.
Age in the registry: 75 years to 100 years · 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 |
|---|---|---|---|
| Pusan National University Yangsan Hospital Coordinator of this site? Confirm its status | Yangsan | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.