An interventional study of Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in Ischemic Heart Disease, Stenotic Coronary Lesion and Cardiovascular Diseases, sponsored by Medtronic Vascular. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Medtronic Vascular (part of Medtronic) · Not applicable, Interventional, and Treatment
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 coronary angioplasty (PTCA) in de novo lesions amenable to treatment with Resolute Onyx™ Stent System in China.
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, 6 Months, 9 Months-subjects implanted with fringe size, and annual assessments from 1-5 years).
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's enrollment of 591 is above the median of 124 across 3,006 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Medtronic Vascular is the lead sponsor of 60 studies on the registry; 7 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Compared within Coronary Artery Disease, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Myocardial Ischemia. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
Device: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
Treatment of subjects eligible for percutaneous transluminal coronary angioplasty (PTCA) as per study requirements
Target Lesion Failure (TLF)
TLF
Time frame: 12 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 any percutaneous method. These measurements will be made by the independent angiographic core laboratory. If the core laboratory is unable to assess the % residual stenosis, the Investigator's assessment as recorded in the CRF will be used for the statistical analysis.
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 any percutaneous method without the occurrence of MACE during the hospital stay. These measurements will be made by the independent angiographic core laboratory. If the core laboratory is unable to assess the % residual stenosis, the Investigator's assessment as recorded in the CRF will be used for the statistical analysis.
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), or clinically-driven repeat target lesion revascularization by percutaneous or surgical methods
Time frame: 30 day, 6 months, 9 months (if applicable), 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 (if applicable), 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 (if applicable), 1 year, 2 years,3 years, 4 years, 5 years
All revascularizations
Combined endpoints including Target Legion Revascularization (TLR), Target Vessel Revascularization (TVR) and Non-TVR
Time frame: 30 day, 6 months, 9 months (if applicable), 1 year, 2 years,3 years, 4 years, 5 years
Target Vessel Failure (TVF)
TVF
Time frame: 30 day, 6 months, 9 months (if applicable), 1 year, 2 years,3 years, 4 years, 5 years
Target Lesion Failure (TLF)
TLF
Time frame: 30 day, 6 months, 9 months (if applicable), 1 year, 2 years,3 years, 4 years, 5 years
Stent Thrombosis (ST)
ST
Time frame: 30 day, 6 months, 9 months (if applicable), 1 year, 2 years,3 years, 4 years, 5 years
In-stent late luminal loss
Only for subjects implanted with certain stent sizes: Angiographic measures: In-stent and In-segment late luminal loss
Time frame: 9 months
In-segment late luminal loss
Only for subjects implanted with certain stent sizes: Angiographic measures: In-stent and In-segment late luminal loss
Time frame: 9 months
In-stent and in-segment percent diameter stenosis (%DS)
Only for subjects implanted with certain stent sizes: Angiographic measures: In-stent and in-segment percent diameter stenosis (%DS)
Time frame: 9 months
In-stent and in-segment binary restenosis rate
Only for subjects implanted with certain stent sizes: Angiographic measures: In-stent and in-segment binary restenosis rate
Time frame: 9 months
In-stent and in-segment minimal luminal diameter (MLD)
Only for subjects implanted with certain stent sizes: Angiographic measures:In-stent and in-segment minimal luminal diameter (MLD)
Time frame: 9 months
Ran from Mar 2018 to primary completion in Feb 2021, 34 months.
Of 177 industry-sponsored interventional studies with no phase under Coronary Artery Disease, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 40. This study's 34 months is above that.
Counting every sponsor, half of 930 studies reached it within 30 months; a quarter within 15 and three quarters within 50.
Completion moved once since we started tracking on Sep 25, 2026: Aug 2026 → Apr 2024, on Oct 21, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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