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The purpose of this study is to verify the safety and effectiveness of the Vascular Closure Device manufactured by Shanghai Bomaian Medical Technology Co., Ltd. for femoral artery hemostasis in patients of femoral artery puncture.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Group | Experimental |
| |
| Control Group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vascular Closure Device Manufactured by Shanghai Bomaian Medical Technology Co., Ltd. | Device | The test group will use the Vascular Closure Device manufactured by Shanghai Bomaian Medical Technology Co., Ltd. for femoral artery hemostasis in patients of femoral artery puncture |
| Measure | Description | Time Frame |
|---|---|---|
| Device Success Rate | Intra-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Hemostasis | Time from completion of femoral artery puncture site closure operation using the vascular closure device system to achievement of hemostasis, which will be assessed up to 1 day | |
| Time to Ambulation | Time from completion of femoral artery puncture site closure operation using the vascular closure device system to the patient's ability to ambulate at least 6 meters, which will be assessed up to 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Major Femoral Access Site Complications within 30 Days Post-Procedure | Up to 37 days | |
| Incidence of Minor Femoral Access Site Complications within 30 Days Post-Procedure | Up to 37 days | |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qingwu Yang | Contact | +86-13657638868 | yangqwmlys@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Army Medical University (PLA) | Chongqing | 400037 | China |
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| MynxGrip Vascular Closure Device Manufactured by Cordis US Corp | Device | The control group will use MynxGrip Vascular Closure Device Manufactured by Cordis US Corp for femoral artery hemostasis in patients of femoral artery puncture |
|
| Time to Hospital Discharge | Time from completion of femoral artery puncture site closure operation using the vascular closure device system to Hospital discharge determined by physician, which will be assessed up to 30 days |
| Incidence of Device Deficiency |
| Day 1 |
| Incidence of Adverse Events | Through study completion, an average of 2 months |
| Incidence of Serious Adverse Events | Through study completion, an average of 2 months |