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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 Percutaneous Common Femoral Vein 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 |
|---|---|---|---|
| SPIDER | Experimental |
| |
| Perclose ProGlide | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPIDER | Device | The intervention utilizes the Vascular Suture System (Model: SPD-100) developed by Suzhou Hengrui Hongyuan Medical Technology Co., Ltd., composed of a vascular suturing device and a suture trimmer. It is intended for closing percutaneous vascular puncture sites in patients undergoing interventional catheter diagnosis or treatment. For femoral artery punctures, it is compatible with 5F-21F sheaths (for sheaths >8F, at least 2 devices and pre-embedded suture technology are required); for femoral vein punctures, it suits 5F-24F sheaths (for sheaths >8F, at least 1 device and pre-embedded suture technology are needed). |
| Measure | Description | Time Frame |
|---|---|---|
| hemostasis success rate | within 10 minutes post-suturing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fu Weiguo Fu | Contact | 13801760929 | fu.weiguo@zs-hospital.sh.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital, Fudan University (Lead Site) | Recruiting | Shanghai | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 脑血管介入术后穿刺血管局部血管缝合器压迫时间的临床观察 | ||
| Background | 血管缝合及吻合基本技术与缝线材料选择专家共识(2008) | ||
| Background | 经股动脉介入诊疗术后应用血管缝合器安全性的系统评价及Meta分析 | ||
| 26948236 | Background | Robertson L, Andras A, Colgan F, Jackson R. Vascular closure devices for femoral arterial puncture site haemostasis. Cochrane Database Syst Rev. 2016 Mar 7;3(3):CD009541. doi: 10.1002/14651858.CD009541.pub2. | |
| 33103545 |
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| Perclose ProGlide | Device | The intervention employs the Perclose ProGlide Vascular Closure System (Model: 12673) manufactured by Abbott, a clinically validated device for closing percutaneous vascular puncture sites. It is indicated for patients undergoing interventional catheter diagnosis or treatment via femoral artery puncture with 5F-21F sheaths, serving as the control in this prospective, multi-center, randomized controlled trial. The device operates by percutaneously delivering sutures through a guidewire: during or after surgery, it accesses the puncture site, deploys sutures to approximate the vascular wall, and secures the suture knot to achieve hemostasis, with the suture permanently implanted in the body. |
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| Background |
| Berti S, Bedogni F, Giordano A, Petronio AS, Iadanza A, Bartorelli AL, Reimers B, Spaccarotella C, Trani C, Attisano T, Marella Cenname A, Sardella G, Bonmassari R, Medda M, Tomai F, Tarantini G, Navarese EP; Italian Society of Interventional Cardiology-GISEdagger. Efficacy and Safety of ProGlide Versus Prostar XL Vascular Closure Devices in Transcatheter Aortic Valve Replacement: The RISPEVA Registry. J Am Heart Assoc. 2020 Nov 3;9(21):e018042. doi: 10.1161/JAHA.120.018042. Epub 2020 Oct 24. |
| 28228304 | Background | Vinayakumar D, Kayakkal S, Rajasekharan S, Thottian JJ, Sankaran P, Bastian C. 24h and 30 day outcome of Perclose Proglide suture mediated vascular closure device: An Indian experience. Indian Heart J. 2017 Jan-Feb;69(1):37-42. doi: 10.1016/j.ihj.2016.06.008. Epub 2016 Jun 28. |