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To evaluate the clinical safety and efficacy in Chinese subjects, eligible for percutaneous transluminal coronary angioplasty (PTCA) in lesions amenable to treatment with a 34/38 mm Medtronic Resolute Integrityâ„¢ Zotarolimus-Eluting Coronary Stent System.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coronary Stent | Experimental | Resolute Integrityâ„¢ Zotarolimus-Eluting Coronary Stent System (34/38 mm) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resolute Integrityâ„¢ Zotarolimus-Eluting Coronary Stent System(34/38 mm) | Device | The stenting procedure should be performed according to the Instructions for Use that is provided with each 34/38 mm Resolute Integrity stent. |
| Measure | Description | Time Frame |
|---|---|---|
| Late lumen loss, in stent | Late lumen loss measured by quantitative coronary angiography (QCA) | 9 months (m) |
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Cardiac Events (MACE) | Defined as death, myocardial infarction (Q wave and non-Q wave), or clinically-driven repeat target lesion revascularization by percutaneous or surgical methods | 30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years |
| Death |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lianglong Chen, MD | Fujian Medical University Union Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Friendship Hospital | Beijing | Beijing Municipality | 100000 | China | ||
| Fujian Medical University Union Hospital |
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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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All death |
| 30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years |
| Myocardial infarction | All MI, and Target Vessel Myocardial Infarction (TVMI) | 30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years |
| All revascularizations | Target Legion Revascularization (TLR), Target Vessel Revascularization (TVR) and Non-TVR | 30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years |
| Target Vessel Failure (TVF) | TVF | 30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years |
| Target Lesion Failure (TLF) | TLF | 30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years |
| Stent Thrombosis (ST) | ST | 30 days, 6 and 9 months, 1, 2, 3, 4, and 5 years |
| Device Success | The attainment of <50% residual stenosis of the target lesion using only the assigned device. 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 index procedure, an expected average of 3 days |
| Lesion Success | The attainment of <50% residual stenosis of the target lesion using any percutaneous method. 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. | At the end of index procedure, an expected average of 3 days |
| Procedure Success | The attainment of <50% residual stenosis of the target lesion and no in-hospital MACE. 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. | Duration of hospital stay, an expected average of 5 days |
| In-stent and in-segment percent diameter stenosis (%DS) | In-stent and in-segment percent diameter stenosis (%DS) | 9 months |
| In-stent and in-segment binary restenosis rate | In-stent and in-segment binary restenosis rate | 9 months |
| In-stent and in-segment minimal luminal diameter (MLD) | In-stent and in-segment minimal luminal diameter (MLD) | 9 months |
| In-segment late luminal loss | In-segment late luminal loss | 9 months |
| Fuzhou |
| Fujian |
| 350001 |
| China |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |