Clinical trial NCT05899478: Suture-mediated Closure System Following Endovascular Peripheral Arterial Procedures
Official title: Prospective, Multi-center, Randomized Controlled Study to Evaluate the Effectiveness and Safety of Suture-mediated Closure System Following Endovascular Peripheral Arterial Procedures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Percutaneous Intervention Via Femoral Artery
Lead sponsor: Suzhou Hengruihongyuan Medical Technology Co. LTD
Sponsor class: INDUSTRY
First posted: 2023-06-12
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of successful hemostasis
timeFrame: 10 minutes
Secondary outcomes:
measure: Operation time
timeFrame: Approximately 15-minutes after device removal
measure: Hemostasis time
timeFrame: Approximately 15-minutes after compression
measure: Technical success rate
timeFrame: Approximately 15-minutes after device removal
measure: Evaluation of Compatibility with guidewires of the device
timeFrame: Approximately 15-minutes after device removal
measure: Evaluation of Pushing performance of the device
timeFrame: Approximately 15-minutes after device removal
measure: Evaluation of Withdrawal performance of the device
timeFrame: Approximately 15-minutes after device removal
measure: Evaluation of Performance of tightening knot of the device
timeFrame: Approximately 15-minutes after device removal
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of USTC
state: Anhui
city: Shanghai
country: China
facility: Zhongshan Hospital
state: Shanghai
city: Hangzhou
country: China
facility: Affiliated Hangzhou First People's Hospital ,Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Yiwu
country: China
facility: The Fourth Affiliated Hospital ,Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References: