Suture-mediated Closure System Following Endovascular Peripheral Arterial Procedures

Percutaneous Intervention Via Femoral Artery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05899478
• Other study ID #: SPD01
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2023
• Est. completion date: May 2024

Study information

• Verified date: May 2023
• Source: Suzhou Hengruihongyuan Medical Technology Co. LTD
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 136
• Est. completion date: May 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Percutaneous Intervention Via Femoral Artery

Intervention

Device:
• Tyknot® Suture-Mediated Closure System
Arterial closure to ensure hemostasis at femoral artery puncture points
• Perclose® ProGlide Suture-Mediated Closure System
Arterial closure to ensure hemostasis at femoral artery puncture points

Locations

Country	Name	City	State
China	Affiliated Hangzhou First People's Hospital ,Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	The Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	The First Affiliated Hospital of USTC	Hefei	Anhui
China	Zhongshan Hospital	Shanghai	Shanghai
China	The Fourth Affiliated Hospital ,Zhejiang University School of Medicine	Yiwu	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Hengruihongyuan Medical Technology Co. LTD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Evaluation of Compatibility with guidewires of the device	Scale from 1 point (worst) to 5 points (best)	Approximately 15-minutes after device removal
Secondary	Evaluation of Pushing performance of the device	Scale from 1 point (worst) to 5 points (best)	Approximately 15-minutes after device removal
Secondary	Evaluation of Withdrawal performance of the device	Scale from 1 point (worst) to 5 points (best)	Approximately 15-minutes after device removal
Secondary	Evaluation of Performance of tightening knot of the device	Scale from 1 point (worst) to 5 points (best)	Approximately 15-minutes after device removal