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The purpose of this study is to evaluate the effectiveness and safety of the suture-mediated closure system produced by Suzhou Hengrui Hongyuan Medical Technology Co., Ltd. following endovascular peripheral arterial procedures.
Prospective, multi-center, randomized Comparative study using the Suture-mediated Closure System produced by Suzhou Hengrui Hongyuan Medical Technology Co., Ltd.as an investigational device and the Perclose® ProGlide Suture-Mediated Closure System as a comparator.
After going through the confirmation of inclusion/exclusion criteria with signed subjects, they will have a procedure either of the two devices. The subjects should follow designated physician's instructions accurately during the clinical trial period. There are about 4 times evaluations Including screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tyknot® Suture-Mediated Closure System | Experimental | Arterial closure device used is Tyknot® Suture-Mediated Closure System |
|
| Perclose® ProGlide Suture-Mediated Closure System | Active Comparator | Arterial closure device used is Perclose® ProGlide Suture-Mediated Closure System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tyknot® Suture-Mediated Closure System | Device | Arterial closure to ensure hemostasis at femoral artery puncture points |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of successful hemostasis | Calculation method: Patients with successful hemostasis / total cases of subjects in the same group x 100%. Definition of successful hemostasis: Within 10 minutes after completion of the suturing procedure, there is no bleeding or hematoma at the puncture site, and no other intervention or surgical treatment is required. | 10 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Operation time | The time for suturing with the vascular closure device. Definition of Operation time: The time it takes for the device to enter the artery, tie the knot, and then be successfully withdrawn from the vessel. | Approximately 15-minutes after device removal |
| Hemostasis time |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of USTC | Hefei | Anhui | 230001 | China | ||
| Zhongshan Hospital |
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| Perclose® ProGlide Suture-Mediated Closure System | Device | Arterial closure to ensure hemostasis at femoral artery puncture points |
|
The time from the catheter sheath is removed to compression is released and no bleeding occurs at the puncture site |
| Approximately 15-minutes after compression |
| Technical success rate | Calculation method: Patients with technical success/ total cases of subjects in the same group x 100%. Definition of Technical success: Successful placement of the device,smooth withdrawal, and completion fo the knot. | Approximately 15-minutes after device removal |
| Evaluation of Compatibility with guidewires of the device | Scale from 1 point (worst) to 5 points (best) | Approximately 15-minutes after device removal |
| Evaluation of Pushing performance of the device | Scale from 1 point (worst) to 5 points (best) | Approximately 15-minutes after device removal |
| Evaluation of Withdrawal performance of the device | Scale from 1 point (worst) to 5 points (best) | Approximately 15-minutes after device removal |
| Evaluation of Performance of tightening knot of the device | Scale from 1 point (worst) to 5 points (best) | Approximately 15-minutes after device removal |
| Shanghai |
| Shanghai Municipality |
| 200032 |
| China |
| Affiliated Hangzhou First People's Hospital ,Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310006 | China |
| The Second Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310009 | China |
| The Fourth Affiliated Hospital ,Zhejiang University School of Medicine | Yiwu | Zhejiang | 322000 | China |