Status:
ACTIVE_NOT_RECRUITING
RESOLUTE ONYX China RCT Study
Lead Sponsor:
Medtronic Vascular
Conditions:
Ischemic Heart Disease
Stenotic Coronary Lesion
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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™ Z...
Detailed Description
This study is a pre-Market, prospective, multi-center, open-label, randomized controlled trial. Subjects will be 1:1 randomized and followed through 5 Years (screen, implant procedure(including post-p...
Eligibility Criteria
Inclusion
- Key
- 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
- Key
Exclusion
- 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
- PCI of the target vessel within 9 months prior to the procedure
- Active bleeding
- Subjects with a life expectancy of less than 12 months
- Participation in another clinical study
- Pregnant, or lactating women
Key Trial Info
Start Date :
April 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2026
Estimated Enrollment :
550 Patients enrolled
Trial Details
Trial ID
NCT03466151
Start Date
April 12 2018
End Date
April 30 2026
Last Update
December 3 2025
Active Locations (2)
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1
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
2
Fuwai Hospital, Chinese Academy of Medical Science
Beijing, China, 100037