Status:
ACTIVE_NOT_RECRUITING
RESOLUTE ONYX China Single Arm Study
Lead Sponsor:
Medtronic Vascular
Conditions:
Ischemic Heart Disease
Stenotic Coronary Lesion
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 coron...
Detailed Description
This study is a pre-Market, prospective, multi-center, single arm trial. Subjects will be enrolled and followed through 5 Years (screen, implant procedure(including post-procedure assessment),30-Day, ...
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, 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
- 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 :
March 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2026
Estimated Enrollment :
591 Patients enrolled
Trial Details
Trial ID
NCT03471845
Start Date
March 30 2018
End Date
April 30 2026
Last Update
November 26 2025
Active Locations (1)
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1
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China