Suture-mediated Closure System Following Endovascular Peripheral Arterial Procedures
NCT ID: NCT05899478
Last Updated: 2025-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
135 participants
INTERVENTIONAL
2023-06-01
2024-04-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tyknot® Suture-Mediated Closure System
Arterial closure device used is Tyknot® Suture-Mediated Closure System
Tyknot® Suture-Mediated Closure System
Arterial closure to ensure hemostasis at femoral artery puncture points
Perclose® ProGlide Suture-Mediated Closure System
Arterial closure device used is Perclose® ProGlide Suture-Mediated Closure System
Perclose® ProGlide Suture-Mediated Closure System
Arterial closure to ensure hemostasis at femoral artery puncture points
Interventions
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Tyknot® Suture-Mediated Closure System
Arterial closure to ensure hemostasis at femoral artery puncture points
Perclose® ProGlide Suture-Mediated Closure System
Arterial closure to ensure hemostasis at femoral artery puncture points
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
80 Years
ALL
No
Sponsors
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Suzhou Hengruihongyuan Medical Technology Co. LTD
INDUSTRY
Responsible Party
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Locations
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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
The Fourth Affiliated Hospital ,Zhejiang University School of Medicine
Yiwu, Zhejiang, China
Countries
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Other Identifiers
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SPD01
Identifier Type: -
Identifier Source: org_study_id
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