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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System | Experimental | Resolute Onyx™ 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 |
|---|---|---|
| Target Lesion Failure (TLF) | TLF | 12 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 |
|---|---|---|
| Ben He, MD | Shanghai Chest Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital of Jiangsu University | Zhenjiang | Jiangsu | China |
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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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Single Group Assignment
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| 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. | 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. | 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 | 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 | 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. | 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 | 30 day, 6 months, 9 months (if applicable), 1 year, 2 years,3 years, 4 years, 5 years |
| Target Vessel Failure (TVF) | TVF | 30 day, 6 months, 9 months (if applicable), 1 year, 2 years,3 years, 4 years, 5 years |
| Target Lesion Failure (TLF) | TLF | 30 day, 6 months, 9 months (if applicable), 1 year, 2 years,3 years, 4 years, 5 years |
| Stent Thrombosis (ST) | ST | 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 | 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 | 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) | 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 | 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) | 9 months |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |