Suture-mediated Closure System Following Endovascular Peripheral Arterial Procedures

Not Applicable

Not yet recruiting

• Conditions: Percutaneous Intervention Via Femoral Artery
• Interventions: Device: Perclose® ProGlide Suture-Mediated Closure System; Device: Tyknot® Suture-Mediated Closure System

• Registration Number: NCT05899478
• Lead Sponsor: Suzhou Hengruihongyuan Medical Technology Co. LTD

Brief Summary

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

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.

Study Timeline

• Status Verified: 2023-05
• Study First Submitted: 2023-05-05
• Study Start: 2023-06
• Study First Submitted QC: 2023-06-02
• Last Update Submitted: 2023-06-02
• Study First Posted: 2023-06-12
• Last Update Posted: 2023-06-12
• Primary Completion: 2024-03
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

1. Aged 18-80
2. Patients who can use 5Fr to 21Fr sheath for common femoral artery puncture for interventional catheterization or therapy
3. Informed consent signed by the patient or legal representative

Exclusion Criteria

1. Pregnancy or lactation period;
2. Diameter of femoral artery site for puncture< 5mm;
3. Have participated in another clinical study during the same period;
4. Known allergy to any device component, and/or contraindications of contrast agents and anticoagulants;
5. Vascular injury at the site of the approach;
6. Groin infection;
7. Morbid obesity (BMI≥40kg / ㎡);
8. Ultrasonographic assessment of the entire common femoral artery wall showed that the common femoral artery stenosis was ≥ 50%;
9. There are femoral aneurysms, arteriovenous fistulas or pseudoaneurysms in the common femoral artery;
10. Clamp vessel closures were used at the previous ipsilateral artery approach;
11. Hematoma at ipsilateral artery approach;
12. Other conditions deemed unsuitable for participation in this clinical trial by the investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Perclose® ProGlide Suture-Mediated Closure System	Perclose® ProGlide Suture-Mediated Closure System	Arterial closure device used is Perclose® ProGlide Suture-Mediated Closure System
Tyknot® Suture-Mediated Closure System	Tyknot® Suture-Mediated Closure System	Arterial closure device used is Tyknot® Suture-Mediated Closure System

Primary Outcome Measures

Name	Time	Method
Rate of successful hemostasis	10 minutes	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.

Secondary Outcome Measures

Name	Time	Method
Evaluation of Withdrawal performance of the device	Approximately 15-minutes after device removal	Scale from 1 point (worst) to 5 points (best)
Operation time	Approximately 15-minutes after device removal	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.
Technical success rate	Approximately 15-minutes after device removal	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.
Evaluation of Performance of tightening knot of the device	Approximately 15-minutes after device removal	Scale from 1 point (worst) to 5 points (best)
Hemostasis time	Approximately 15-minutes after compression	The time from the catheter sheath is removed to compression is released and no bleeding occurs at the puncture site
Evaluation of Compatibility with guidewires of the device	Approximately 15-minutes after device removal	Scale from 1 point (worst) to 5 points (best)
Evaluation of Pushing performance of the device	Approximately 15-minutes after device removal	Scale from 1 point (worst) to 5 points (best)

Trial Locations

Locations (5)

The Fourth Affiliated Hospital ,Zhejiang University School of Medicine; 🇨🇳 Yiwu, Zhejiang, China

The First Affiliated Hospital of USTC; 🇨🇳 Hefei, Anhui, China

Zhongshan Hospital; 🇨🇳 Shanghai, Shanghai, China

The Second Affiliated Hospital of Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China

Affiliated Hangzhou First People's Hospital ,Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China