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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
135
Arterial closure to ensure hemostasis at femoral artery puncture points
Arterial closure to ensure hemostasis at femoral artery puncture points
The First Affiliated Hospital of USTC
Hefei, Anhui, China
Zhongshan Hospital
Shanghai, Shanghai Municipality, 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
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.
Time frame: 10 minutes
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of Operation time: The time it takes for the device to enter the artery, tie the knot, and then be successfully withdrawn from the vessel.
Time frame: 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
Time frame: 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.
Time frame: Approximately 15-minutes after device removal
Evaluation of Compatibility with guidewires of the device
Scale from 1 point (worst) to 5 points (best)
Time frame: Approximately 15-minutes after device removal
Evaluation of Pushing performance of the device
Scale from 1 point (worst) to 5 points (best)
Time frame: Approximately 15-minutes after device removal
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The Fourth Affiliated Hospital ,Zhejiang University School of Medicine
Yiwu, Zhejiang, China
Evaluation of Withdrawal performance of the device
Scale from 1 point (worst) to 5 points (best)
Time frame: Approximately 15-minutes after device removal
Evaluation of Performance of tightening knot of the device
Scale from 1 point (worst) to 5 points (best)
Time frame: Approximately 15-minutes after device removal