Ischemic Heart DiseaseNCT03471845
RESOLUTE ONYX China Single Arm Study
A study testing Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in people with Ischemic Heart Disease and Stenotic Coronary Lesion, run by Medtronic Vascular at 1 site in China.
Trial 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 coronary angioplasty (PTCA) in de novo lesions amenable to treatment with Resolute Onyx™ Stent System in China. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Heart Disease, Stenotic Coronary Lesion, Cardiovascular Diseases
- What is being tested?
- Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 591 participants
- Where
- 1 siteChina
- Study dates
- 30 Mar 2018to 4 Apr 2024
- 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, 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
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
1 site in 1 country.
About this study
Official title: A Single Arm Clinical Evaluation of Safety and Efficacy of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in the Treatment of Subjects Eligible for Percutaneous Transluminal Coronary Angioplasty (PTCA) in China
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.
Read the 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, 6 Months, 9 Months-subjects implanted with fringe size, and annual assessments from 1-5 years).
- Conditions
- Ischemic Heart Disease, Stenotic Coronary Lesion, Cardiovascular Diseases, Arteriosclerosis, Coronary Artery Disease
- Being tested
- Resolute Onyx™ 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), 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
| Study group | Role | What they receive |
|---|---|---|
| Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System | Experimental | Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System Receives: Device: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Lesion Failure (TLF)
TLF
Measured: 12 months
Secondary outcomes (15)
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
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 30 day, 6 months, 9 months (if applicable), 1 year, 2 years,3 years, 4 years, 5 years
Target Vessel Failure (TVF)
TVF
Measured: 30 day, 6 months, 9 months (if applicable), 1 year, 2 years,3 years, 4 years, 5 years
Target Lesion Failure (TLF)
TLF
Measured: 30 day, 6 months, 9 months (if applicable), 1 year, 2 years,3 years, 4 years, 5 years
Stent Thrombosis (ST)
ST
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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)
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2018
- Study start30 Mar 2018
- Primary completion24 Feb 2021
- Study completion4 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 591 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Vascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ben He, MD, Principal investigator, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03471845
- Sponsor's protocol ID
- MDT16058RES004
- 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
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm Clinical Evaluation of Safety and Efficacy of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in the Treatment of Subjects Eligible for Percutaneous Transluminal Coronary Angioplasty (PTCA) in China
- ClinicalTrials.gov ID
- NCT03471845
- Acronym / sponsor ID
- MDT16058RES004
- Conditions
- Ischemic Heart Disease, Stenotic Coronary Lesion, Cardiovascular Diseases, Arteriosclerosis, Coronary Artery Disease
- 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)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 591 participants (actual)
- Lead sponsor
- Medtronic VascularIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2018 (actual)
- Primary completion
- 24 Feb 2021 (actual)
- Study completion
- 4 Apr 2024 (actual)
- First posted
- 21 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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, 6 Months, 9 Months-subjects implanted with fringe size, and annual assessments from 1-5 years).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System | Experimental | Device: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent SystemResolute Onyx™ Zotarolimus-Eluting Coronary Stent System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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 criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resolute Onyx™ Zotarolimus-Eluting Coronary Stent SystemTreatment of subjects eligible for percutaneous transluminal coronary angioplasty (PTCA) as per study requirements | Device | Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System |
Primary outcome
Target Lesion Failure (TLF)
Time frame: 12 months
TLF
15 secondary outcomes
Device Success
Time frame: at the end of the index procedure or during hospital stay:estimated 7 days
Lesion Success
Time frame: at the end of the index procedure or during hospital stay: estimated 7 days
Procedure Success
Time frame: at the end of the index procedure or during hospital stay: estimated 7 days
Major Adverse Cardiac Events (MACE)
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)
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))
Time frame: 30 day, 6 months, 9 months (if applicable), 1 year, 2 years,3 years, 4 years, 5 years
All revascularizations
Time frame: 30 day, 6 months, 9 months (if applicable), 1 year, 2 years,3 years, 4 years, 5 years
Target Vessel Failure (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)
Time frame: 30 day, 6 months, 9 months (if applicable), 1 year, 2 years,3 years, 4 years, 5 years
Stent Thrombosis (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
Time frame: 9 months
In-segment late luminal loss
Time frame: 9 months
In-stent and in-segment percent diameter stenosis (%DS)
Time frame: 9 months
In-stent and in-segment binary restenosis rate
Time frame: 9 months
In-stent and in-segment minimal luminal diameter (MLD)
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ben He, MD principal investigator
Shanghai Chest Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in people with Ischemic Heart Disease and Stenotic Coronary Lesion, run by Medtronic Vascular at 1 site 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 1 site 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?
Target Lesion Failure (TLF) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.