Suture-mediated Closure System Following Endovascular Peripheral Arterial Procedures
Prospective, Multi-center, Randomized Controlled Study to Evaluate the Effectiveness and Safety of Suture-mediated Closure System Following Endovascular Peripheral Arterial Procedures
1 other identifier
interventional
135
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2023
Shorter than P25 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 5, 2023
CompletedStudy Start
First participant enrolled
June 1, 2023
CompletedFirst Posted
Study publicly available on registry
June 12, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2024
CompletedJune 25, 2025
June 1, 2025
7 months
May 5, 2023
June 19, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
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
- +2 more secondary outcomes
Study Arms (2)
Tyknot® Suture-Mediated Closure System
EXPERIMENTALArterial closure device used is Tyknot® Suture-Mediated Closure System
Perclose® ProGlide Suture-Mediated Closure System
ACTIVE COMPARATORArterial closure device used is Perclose® ProGlide Suture-Mediated Closure System
Interventions
Arterial closure to ensure hemostasis at femoral artery puncture points
Arterial closure to ensure hemostasis at femoral artery puncture points
Eligibility Criteria
You may qualify if:
- Aged 18-80
- Patients who can use 5Fr to 21Fr sheath for common femoral artery puncture for interventional catheterization or therapy
- Informed consent signed by the patient or legal representative
You may not qualify if:
- Pregnancy or lactation period;
- Diameter of femoral artery site for puncture\< 5mm;
- Have participated in another clinical study during the same period;
- Known allergy to any device component, and/or contraindications of contrast agents and anticoagulants;
- Vascular injury at the site of the approach;
- Groin infection;
- Morbid obesity (BMI≥40kg / ㎡);
- Ultrasonographic assessment of the entire common femoral artery wall showed that the common femoral artery stenosis was ≥ 50%;
- There are femoral aneurysms, arteriovenous fistulas or pseudoaneurysms in the common femoral artery;
- Clamp vessel closures were used at the previous ipsilateral artery approach;
- Hematoma at ipsilateral artery approach;
- Other conditions deemed unsuitable for participation in this clinical trial by the investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2023
First Posted
June 12, 2023
Study Start
June 1, 2023
Primary Completion
January 1, 2024
Study Completion
April 1, 2024
Last Updated
June 25, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share