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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System | Experimental | Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System |
|
| Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System | Active Comparator | Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System | Device | Treatment of subjects eligible for percutaneous transluminal coronary angioplasty (PTCA) as per study requirements |
| Measure | Description | Time Frame |
|---|---|---|
| In-stent Late lumen loss measured by quantitative coronary angiography (QCA) | Late lumen loss measured by quantitative coronary angiography (QCA) | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at the end of the index procedure or during hospital stay: estimated 7 days |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yongjian Wu, MD | Fuwai Hospital, Chinese Academy of Medical Science | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shengjing Hospital of China Medical University | Shenyang | Liaoning | China | |||
| Fuwai Hospital, Chinese Academy of Medical Science |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 13, 2019 | Apr 7, 2025 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 22, 2020 | Apr 12, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D003324 | Coronary Artery Disease |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D014652 | Vascular Diseases |
| D001157 | Arterial Occlusive Diseases |
| D003327 | Coronary Disease |
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1:1 Randomization
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| Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System | Device | Treatment of subjects eligible for percutaneous transluminal coronary angioplasty (PTCA) as per study requirements |
|
| 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. | 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. | 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 | 30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years |
| Death (Cardiac and Non-cardiac) | All deaths | 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. | 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 | 30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years |
| Target Vessel Failure (TVF) | TVF | 30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years |
| Target Lesion Failure (TLF) | TLF | 30 day, 6 months, 9 months, 1 year, 2 years,3 years, 4 years, 5 years |
| Stent Thrombosis (ST) | ST | 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) | 9 months |
| In-stent and in-segment binary restenosis rate | Angiographic measures:In-stent and in-segment binary restenosis rate | 9 months |
| In-stent and in-segment minimal luminal diameter (MLD) | Angiographic measures:In-stent and in-segment minimal luminal diameter (MLD) | 9 months |
| In-segment late luminal loss | Angiographic measures: In-segment late luminal loss | 9 months |
| Beijing |
| 100037 |
| China |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |