NCT03471845Completed
RESOLUTE ONYX China Single Arm Study
A Single Arm Clinical Evaluation of Safety and Efficacy of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in the Treatment of Subjects Eligible for Percutaneous Transluminal Coronary Angioplasty (PTCA) in China
Source: ClinicalTrials.gov · Last updated 21 Oct 2026
Brief summary (registry, in English)
It is a single arm clinical evaluation of safety and efficacy of the Medtronic Resolute Onyx™ zotarolimus-eluting coronary stent system in subjects who are eligible for percutaneous transluminal coronary angioplasty (PTCA) in de novo lesions amenable to treatment with Resolute Onyx™ Stent System in China.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 591 (actual)
- First submitted
- 1 Mar 2018
- Start date
- 30 Mar 2018
- Primary completion date
- 24 Feb 2021
- Lead sponsor
- Medtronic Vascular
- Diseases
- Coronary artery disease
- NCT number
- NCT03471845
What you commit to
- Study type: Interventional
- Participants enrolled: 591
- From 30 Mar 2018 to the primary completion date, 24 Feb 2021
- 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
- PCI of the target vessel within 9 months prior to the procedure
Other illness
- Known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, P2Y12 inhibitors, mTOR inhibiting drugs such as zotarolimus, Biolimus A9 (or its derivatives), cobalt, nickel, platinum, iridium, chromium, molybdenum, polymer coatings (e.g. BioLinx) or a sensitivity to contrast media, which cannot be adequately pre-medicated
- Active bleeding
Other
- Subjects with a life expectancy of less than 12 months
- Participation in another clinical study
- Pregnant, or lactating women
Who the study is looking for
- The subject is an acceptable candidate for treatment with a drug-eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions, and the IB of Resolute Onyx stent.
- The subject requires treatment of up to 3 target lesions in up to 2 separate target vessels \[2 target lesions in 1 vessel (including its side branches) and 1 target lesion in a separate vessel (including its side branches)\] amenable to treatment with stents with diameter from 2.25 mm to 5.0 mm
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Affiliated Hospital of Jiangsu University Coordinator of this site? Confirm its status | Zhenjiang | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.