Suture-mediated Closure System Following Endovascular Peripheral Arterial Procedures

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prospective, Multi-center, Randomized Controlled Study to Evaluate the Effectiveness and Safety of Suture-mediated Closure System Following Endovascular Peripheral Arterial Procedures

Conditions
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Percutaneous Intervention Via Femoral Artery

Intervention / Treatment
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* Device: Tyknot® Suture-Mediated Closure System
* Device: Perclose® ProGlide Suture-Mediated Closure System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18-80 Patients who can use 5Fr to 21Fr sheath for common femoral artery puncture for interventional catheterization or therapy Informed consent signed by the patient or legal representative Exclusion Criteria: Pregnancy or lactation period; Diameter of femoral artery site for puncture< 5mm; Have participated in another clinical study during the same period; Known allergy to any device component, and/or contraindications of contrast agents and anticoagulants; Vascular injury at the site of the approach; Groin infection; Morbid obesity (BMI≥40kg / ㎡); Ultrasonographic assessment of the entire common femoral artery wall showed that the common femoral artery stenosis was ≥ 50%; There are femoral aneurysms, arteriovenous fistulas or pseudoaneurysms in the common femoral artery; Clamp vessel closures were used at the previous ipsilateral artery approach; Hematoma at ipsilateral artery approach; Other conditions deemed unsuitable for participation in this clinical trial by the investigator.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tyknot® Suture-Mediated Closure System<br>Arterial closure device used is Tyknot® Suture-Mediated Closure System | Device: Tyknot® Suture-Mediated Closure System<br>* Arterial closure to ensure hemostasis at femoral artery puncture points<br>|
| Active Comparator: Perclose® ProGlide Suture-Mediated Closure System<br>Arterial closure device used is Perclose® ProGlide Suture-Mediated Closure System | Device: Perclose® ProGlide Suture-Mediated Closure System<br>* Arterial closure to ensure hemostasis at femoral artery puncture points<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |