Prospective, Multi-center, Randomized Controlled Study to Evaluate the Effectiveness and Safety of Suture-mediated Closure System Following Endovascular Peripheral Arterial Procedures
Sponsor study identifier
interventional
135
1 country
5
Study Start
June 1, 2023
Actual (reported)Primary Completion
January 1, 2024
Actual (reported)Study Completion
April 1, 2024
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 1, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 5, 2023
Actual (reported)June 1, 2023
Actual (reported)June 12, 2023
Actual (reported)January 1, 2024
Actual (reported)April 1, 2024
Actual (reported)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
Operation time
Approximately 15-minutes after device removal
Hemostasis time
Approximately 15-minutes after compression
Technical success rate
Approximately 15-minutes after device removal
Evaluation of Compatibility with guidewires of the device
Approximately 15-minutes after device removal
Evaluation of Pushing performance of the device
Approximately 15-minutes after device removal
Arterial closure device used is Tyknot® Suture-Mediated Closure System
Arterial closure device used is Perclose® ProGlide Suture-Mediated Closure System
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, 230001, China
Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032, China
Affiliated Hangzhou First People's Hospital ,Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310006, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
The Fourth Affiliated Hospital ,Zhejiang University School of Medicine
Yiwu, Zhejiang, 322000, China
135 participants (actual enrollment reported by the registry).
First Submitted
May 5, 2023
First Posted
June 12, 2023
Study Start
June 1, 2023
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
January 1, 2024
Actual (reported)Study Completion
April 1, 2024
Actual (reported)Last Updated
June 25, 2025
Record last verified: 2025-06
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Source: ClinicalTrials.gov.
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