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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
| CCRF Consulting Co., Ltd. | OTHER |
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The purpose of PREPARE trial is to evaluate the long-term safety and efficacy of TRI versus TFI for PCI in patients with left main (LM) and/or three-vessel coronary artery disease.
Transradial intervention (TRI) has been widely practiced in China, accounting for approximate 80 to 90% of procedures. A recent meta-analysis indicated that TRI has advantages in reducing major bleeding and ischemic events compared to transfemoral intervention (TFI) after the percutaneous coronary intervention (PCI). However, no clinical trial has yet shown statistical equivalence in terms of long-term efficacy of TRI compared with TFI for the treatment of complex coronary lesions, which is simply due to limited numbers of subjects enrolled. The purpose of PREPARE trial is to evaluate the long-term safety and efficacy of TRI versus TFI for PCI in patients with left main (LM) and/or three-vessel coronary artery disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Femoral approach group | Active Comparator | PCI through Femoral approach |
|
| radial approach group | Experimental | PCI through radial approach |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transfemoral intervention (TFI) | Procedure |
| ||
| Transradial intervention |
| Measure | Description | Time Frame |
|---|---|---|
| major adverse cardiac and cerebrovascular events (MACCE) at 12 months | The primary endpoint is the major adverse cardiac and cerebrovascular events (MACCE) defined as the composite of all-caused death, all stroke, all myocardial infarction (MI), or any revascularization at 12 months. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| The second endpoint is the rate of first occurrence of bleeding complication (BARC Definition type 3 and 5) at 7 days post-procedure | - The second endpoint is the rate of first occurrence of bleeding complication (BARC Definition type 3 and 5) at 7 days post-procedure | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Other outcomes |
|
Inclusion Criteria:
Angiographic inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yuejing Yang, Professor | Chinese Academy of Medical Sciences, Fuwai Hospital | Principal Investigator |
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| Procedure |
|
| 5years |