NCT03466151Completed
RESOLUTE ONYX China RCT Study
A Randomized Controlled Trial to Evaluate the Safety and Efficacy of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in Comparison With the Medtronic Resolute Integrity™ 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 randomized controlled trial to evaluate the safety and efficacy of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in comparison with the Medtronic Resolute Integrity™ Zotarolimus-Eluting coronary stent system in the treatment of subjects eligible for percutaneous transluminal coronary angioplasty (PTCA) in China.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 550 (actual)
- First submitted
- 1 Mar 2018
- Start date
- 12 Apr 2018
- Primary completion date
- 12 Feb 2021
- Lead sponsor
- Medtronic Vascular
- Diseases
- Coronary artery disease
- NCT number
- NCT03466151
What you commit to
- Study type: Interventional
- Participants enrolled: 550
- From 12 Apr 2018 to the primary completion date, 12 Feb 2021
- 2 sites 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, the IB of Resolute Onyx stent, and the IFU of Resolute Integrity 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 4.0 mm
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fuwai Hospital, Chinese Academy of Medical Science Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Shengjing Hospital Of China Medical University Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.