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Clinical Trials in China / NCT03466151
Active, not recruiting Not applicable

RESOLUTE ONYX China RCT Study

NCT03466151 · tracked via the Priya Life Science China tracker
Sponsor
Medtronic Vascular
Phase
Not applicable
Started
2018-04-12
Last updated
2026-04-22

Condition(s) studied

Ischemic Heart DiseaseStenotic Coronary LesionCardiovascular DiseasesArteriosclerosisCoronary Artery Disease

Investigational drug(s) / intervention(s)

Resolute Onyx™ Zotarolimus-Eluting Coronary Stent SystemResolute Integrity™ Zotarolimus-Eluting Coronary Stent System

Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System: Treatment of subjects eligible for percutaneous transluminal coronary angioplasty (PTCA) as per study requirements

Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System: Treatment of subjects eligible for percutaneous transluminal coronary angioplasty (PTCA) as per study requirements

Study 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™ Zotarolimus-Eluting coronary stent system in the treatment of subjects eligible for percutaneous transluminal coronary angioplasty (PTCA) in China.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Key Inclusion Criteria: * 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 Criteria: * 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

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Shengjing Hospital of China Medical University Shenyang Liaoning
Fuwai Hospital, Chinese Academy of Medical Science Beijing China

More Medtronic Vascular trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03466151 on ClinicalTrials.gov ↗ ← All trials in China