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The purpose of this study is to verify the safety and efficacy of the Vascular Closure Device (Tonbridge) in hemostasis treatment for femoral artery puncture.
This is a prospective, multicenter, randomized control, non-inferiority clinical trial carried out in 7 centers throughout China. 228 subjects with hemostasis of femoral artery puncture will be treated with the Vascular Closure Device (Tonbridge) or the EXOSEAL Vascular Closure Device (Codis Corporation). The primary objective of this study is to evaluate the safety and effectiveness of the vascular closure device in hemostasis treatment for femoral artery puncture.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental | Vascular Closure Device (Tonbridge) |
|
| control group | Active Comparator | EXOSEAL Vascular Closure Device (Codis Corporation) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vascular Closure Device (Tonbridge) | Device | Hemostasis treatment for femoral artery puncture with Vascular Closure Device (Tonbridge). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Immediate hemostasis success rate | Immediate hemostasis success is defined as no significant blood oozing and no visible or palpable expanding or developing hematoma on femoral artery puncture site within 5 minutes, once completing the closure operation of femoral artery puncture site using vascular closure device. | intra-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Time to hemostasis | The time it takes (unit: minute) to reach no significant blood oozing and no visible or palpable expanding or developing hematoma on femoral artery puncture site, once completing the closure operation of femoral artery puncture site using vascular closure device. | intra-procedure |
| Incidence of complications associated with femoral artery access |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tianxiao Li | Henan Provincial People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Wannan Medical College | Wuhu | Anhui | China | |||
| Nanyang Central Hospital |
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| EXOSEAL Vascular Closure Device (Codis Corporation) | Device | Hemostasis treatment for femoral artery puncture with EXOSEAL Vascular Closure Device (Codis Corporation). |
|
"Incidence of complications associated with femoral artery access" is the proportion of subjects with femoral artery access complications using the investigational device or the comparator. |
| 30±7 days post-procedure |
| Incidence of device deficiency | Device deficiency is the unreasonable risk that may endanger human health and life safety under normal use of medical devices during clinical trials, such as labeling errors, quality problems and malfunctions, etc. | intra-procedure |
| Incidence of adverse events (AE) | "Incidence of adverse events" is the proportion of subjects with adverse events using the investigational device or the comparator. | 30±7 days post-procedure |
| Incidence of serious adverse events (SAE) | "Incidence of serious adverse events" is the proportion of subjects with serious adverse events using the investigational device or the comparator. | 30±7 days post-procedure |
| Nanyang |
| Henan |
| China |
| Puyang Oilfield General Hospital | Puyang | Henan | China |
| Henan Provincial People's Hospital | Zhengzhou | Henan | China |
| The Second Affiliated Hospital of Soochow University | Suzhou | Jiangsu | China |
| General Hospital of Northern Theater Command | Shenyang | Liaoning | China |
| The Second Affiliated Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang | China |
| ID | Term |
|---|---|
| D065506 | Vascular Closure Devices |
| ID | Term |
|---|---|
| D053831 | Surgical Fixation Devices |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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