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Ischemic Heart DiseaseNCT03466151

RESOLUTE ONYX China RCT Study

A study testing Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System and Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System in people with Ischemic Heart Disease and Stenotic Coronary Lesion, run by Medtronic Vascular at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System and Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
550 participants
Where
2 sitesChina
Study dates
12 Apr 2018to 21 May 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Fuwai Hospital, Chinese Academy of Medical Science

    Beijing, 100037

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning

Other trials in China

About this study

Official title: 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

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.

Read the 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-procedure assessment),30-Day, 6 Months, 9 Months (primary endpoint_LLL), and annual assessments from 1-5 years).

Being tested
Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System
Keywords
Major Adverse Cardiac Events (MACE), Myocardial Infarction (MI), Late Lumen Loss (LLL), Target Lesion Revascularization (TLR), Target Vessel Revascularization (TVR), Target Vessel Failure (TVF), Target Lesion Failure (TLF), Stent Thrombosis (ST), The Randomized Controlled Trial, PERCUTANEOUS CORONARY INTERVENTION (PCI)
Medical subject headings
Myocardial Ischemia, Cardiovascular Diseases, Arteriosclerosis, Coronary Artery Disease, Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Resolute Onyx™ Zotarolimus-Eluting Coronary Stent SystemDevice

    Treatment of subjects eligible for percutaneous transluminal coronary angioplasty (PTCA) as per study requirements

  • Resolute Integrity™ Zotarolimus-Eluting Coronary Stent SystemDevice

    Treatment of subjects eligible for percutaneous transluminal coronary angioplasty (PTCA) as per study requirements

Study groups in NCT03466151
Study groupRoleWhat they receive
Resolute Onyx™ Zotarolimus-Eluting Coronary Stent SystemExperimentalResolute Onyx™ Zotarolimus-Eluting Coronary Stent System
Receives: Device: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
Resolute Integrity™ Zotarolimus-Eluting Coronary Stent SystemActive comparatorResolute Integrity™ Zotarolimus-Eluting Coronary Stent System
Receives: Device: Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. In-stent Late lumen loss measured by quantitative coronary angiography (QCA)

    Late lumen loss measured by quantitative coronary angiography (QCA)

    Measured: 9 months

Secondary outcomes (14)

  1. 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.

    Measured: at the end of the index procedure or during hospital stay: estimated 7 days

  2. 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.

    Measured: at the end of the index procedure or during hospital stay: estimated 7 days

  3. 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.

    Measured: at the end of the index procedure or during hospital stay: estimated 7 days

  4. 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

    Measured: 30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years

  5. Death (Cardiac and Non-cardiac)

    All deaths

    Measured: 30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years

  6. Myocardial infarction (all MI, and Target Vessel Myocardial Infarction (TVMI))

    All myocardial infarction data will be reported per Medtronic historical protocol definitions.

    Measured: 30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years

  7. All revascularizations

    Target Legion Revascularization (TLR), Target Vessel Revascularization (TVR) and Non-TVR

    Measured: 30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years

  8. Target Vessel Failure (TVF)

    TVF

    Measured: 30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years

  9. Target Lesion Failure (TLF)

    TLF

    Measured: 30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years

  10. Stent Thrombosis (ST)

    ST

    Measured: 30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years

  11. In-stent and in-segment percent diameter stenosis (%DS)

    Angiographic measures: In-stent and in-segment percent diameter stenosis (%DS)

    Measured: 9 months

  12. In-stent and in-segment binary restenosis rate

    Angiographic measures:In-stent and in-segment binary restenosis rate

    Measured: 9 months

  13. In-stent and in-segment minimal luminal diameter (MLD)

    Angiographic measures:In-stent and in-segment minimal luminal diameter (MLD)

    Measured: 9 months

  14. In-segment late luminal loss

    Angiographic measures: In-segment late luminal loss

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2018
  2. Study start12 Apr 2018
  3. Primary completion12 Feb 2021
  4. Study completion21 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
1:1 Randomization
Masking
None (open label)
Enrolment
550 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03466151
Sponsor's protocol ID
MDT16061RES005
Status last verified
Oct 2026
First submitted
1 Mar 2018
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System and Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System in people with Ischemic Heart Disease and Stenotic Coronary Lesion, run by Medtronic Vascular at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

In-stent Late lumen loss measured by quantitative coronary angiography (QCA) (time frame: 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03466151.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.

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RESOLUTE ONYX China RCT Study (NCT03466151) | AzTrials