Suture-mediated Closure System Following Endovascular Peripheral Arterial Procedures

Hengruihongyuan Medical Technology

Status: Not yet enrolling

Conditions: Percutaneous Intervention Via Femoral Artery

Treatments: Device: Tyknot® Suture-Mediated Closure System; Device: Perclose® ProGlide Suture-Mediated Closure System

Study type: Interventional

Funder types: Industry

Identifiers

NCT05899478

SPD01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 136 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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136 participants in 2 patient groups

Tyknot® Suture-Mediated Closure System

Experimental group

Description:

Arterial closure device used is Tyknot® Suture-Mediated Closure System

Treatment:

Device: Tyknot® Suture-Mediated Closure System

Perclose® ProGlide Suture-Mediated Closure System

Active Comparator group

Description:

Arterial closure device used is Perclose® ProGlide Suture-Mediated Closure System

Treatment:

Device: Perclose® ProGlide Suture-Mediated Closure System