An interventional study of Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System and Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System in Ischemic Heart Disease, Stenotic Coronary Lesion and Cardiovascular Diseases, sponsored by Medtronic Vascular. Active, not recruiting at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-22.
Sponsored by Medtronic Vascular · Not applicable, Interventional, and Treatment
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.
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-procedure assessment),30-Day, 6 Months, 9 Months (primary endpoint_LLL), and annual assessments from 1-5 years).
Key Inclusion Criteria:
Key Exclusion Criteria:
Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
Device: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System
Device: Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System
Treatment of subjects eligible for percutaneous transluminal coronary angioplasty (PTCA) as per study requirements
Treatment of subjects eligible for percutaneous transluminal coronary angioplasty (PTCA) as per study requirements
In-stent Late lumen loss measured by quantitative coronary angiography (QCA)
Late lumen loss measured by quantitative coronary angiography (QCA)
Time frame: 9 months
Device Success
Definition 1: The attainment of \<50% residual stenosis of the target lesion using only the assigned device. Definition 2: The attainment of \< 30% residual stenosis by QCA (or \< 20% by visual assessment) AND a TIMI flow 3 after the procedure, using the assigned device only. These measurements will be made by the independent angiographic core laboratory.
Time frame: at the end of the index procedure or during hospital stay: estimated 7 days
Lesion Success
Definition 1: The attainment of \<50% residual stenosis of the target lesion using any percutaneous method. Definition 2: The attainment of \< 30% residual stenosis by QCA (or \< 20% by visual assessment) AND a TIMI flow 3 after the procedure, using the assigned device only. These measurements will be made by the independent angiographic core laboratory.
Time frame: at the end of the index procedure or during hospital stay: estimated 7 days
Procedure Success
Definition 1: The attainment of \<50% residual stenosis of the target lesion and no in-hospital MACE. Definition 2: The attainment of \< 30% residual stenosis by QCA (or \< 20% by visual assessment) AND a TIMI flow 3 after the procedure, using the assigned device only. These measurements will be made by the independent angiographic core laboratory.
Time frame: at the end of the index procedure or during hospital stay: estimated 7 days
Major Adverse Cardiac Events (MACE)
Defined as composite of death, myocardial infarction (Q wave and non-Q wave), emergent coronary bypass surgery, or clinically-driven repeat target lesion revascularization by percutaneous or surgical methods
Time frame: 30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years
Death (Cardiac and Non-cardiac)
All deaths
Time frame: 30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years
Myocardial infarction (all MI, and Target Vessel Myocardial Infarction (TVMI))
All myocardial infarction data will be reported per Medtronic historical protocol definitions.
Time frame: 30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years
All revascularizations
Target Legion Revascularization (TLR), Target Vessel Revascularization (TVR) and Non-TVR
Time frame: 30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years
Target Vessel Failure (TVF)
TVF
Time frame: 30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years
Target Lesion Failure (TLF)
TLF
Time frame: 30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years
Stent Thrombosis (ST)
ST
Time frame: 30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years
In-stent and in-segment percent diameter stenosis (%DS)
Angiographic measures: In-stent and in-segment percent diameter stenosis (%DS)
Time frame: 9 months
In-stent and in-segment binary restenosis rate
Angiographic measures:In-stent and in-segment binary restenosis rate
Time frame: 9 months
In-stent and in-segment minimal luminal diameter (MLD)
Angiographic measures:In-stent and in-segment minimal luminal diameter (MLD)
Time frame: 9 months
In-segment late luminal loss
Angiographic measures: In-segment late luminal loss
Time frame: 9 months
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This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Medtronic Vascular