Safety and Efficacy of the Vascular Closure Device (Tonbridge) in Hemostasis Treatment of Femoral Artery Puncture

Study Overview
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Brief Summary
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The purpose of this study is to verify the safety and efficacy of the Vascular Closure Device (Tonbridge) in hemostasis treatment for femoral artery puncture.

Detailed Description
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This is a prospective, multicenter, randomized control, non-inferiority clinical trial carried out in 7 centers throughout China. 228 subjects with hemostasis of femoral artery puncture will be treated with the Vascular Closure Device (Tonbridge) or the EXOSEAL Vascular Closure Device (Codis Corporation). The primary objective of this study is to evaluate the safety and effectiveness of the vascular closure device in hemostasis treatment for femoral artery puncture.

Official Title
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Safety and Efficacy of the Vascular Closure Device (Tonbridge) in Hemostasis Treatment of Femoral Artery Puncture: A Prospective, Multicenter, Randomized Controlled, Non-inferiority Trial

Conditions
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Vascular Closure, Endovascular Procedure, Hemostasis, Femoral Artery, Puncture

Intervention / Treatment
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* Device: Vascular Closure Device (Tonbridge)
* Device: EXOSEAL Vascular Closure Device (Codis Corporation)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-80, male or non-pregnant female; Subjects undergoing unilateral femoral artery retrograde puncture for angiography or interventional procedure; Using guide sheath ≥5F to ≤8F, and length ≤12cm in angiography or interventional procedure; Subjects or their legal guardians voluntarily participate in this study, can complete follow-ups, and sign the informed consent form. Exclusion Criteria: Ipsilateral common femoral artery occlusion or lumen diameter < 5mm; Inability to walk; Allergy to contrast media; Allergy to PGA or PEG; subjects with a history of common femoral artery surgery, percutaneous transluminal angioplasty (PTA), stent implantation, or vascular graft; Subjects with bleeding tendency, such as thrombocytopenia (platelet count <100×109/L), hemophilia, von willebrand diseases, pre-procedure INR >1.5, etc.; Subjects have taken anticoagulants for a long term before the procedure and have blood coagulation disorders; BMI >40kg/m^2; Subjects receive thrombolytic therapy (such as streptokinase, urokinase, t-PA) within≤24 hours before vascular closure; Local infections or skin infections of the investigational limb; Subjects with target femoral artery dissection or aneurysm within 30 days before intervention procedure; Subjects with puncture site have been punctured through the posterior wall of the femoral artery, or have been punctured several times (≥3 times), or have bleeding or hematoma on the femoral artery puncture site during the procedure; Subjects with clinically significant peripheral vascular diseases (such as severe calcification, arteritis, stenosis, etc) near the puncture site; Women who are pregnant or breastfeeding, OR men or women who plan to have a child in the next 6 months; Subjects who are enrolled in other clinical trials and don't complete; Subjects are considered not suitable for enrollment by the investigators.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>Vascular Closure Device (Tonbridge) | Device: Vascular Closure Device (Tonbridge)<br>* Hemostasis treatment for femoral artery puncture with Vascular Closure Device (Tonbridge).<br>|
| Active Comparator: control group<br>EXOSEAL Vascular Closure Device (Codis Corporation) | Device: EXOSEAL Vascular Closure Device (Codis Corporation)<br>* Hemostasis treatment for femoral artery puncture with EXOSEAL Vascular Closure Device (Codis Corporation).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immediate hemostasis success rate | Immediate hemostasis success is defined as no significant blood oozing and no visible or palpable expanding or developing hematoma on femoral artery puncture site within 5 minutes, once completing the closure operation of femoral artery puncture site using vascular closure device. | intra-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to hemostasis | The time it takes (unit: minute) to reach no significant blood oozing and no visible or palpable expanding or developing hematoma on femoral artery puncture site, once completing the closure operation of femoral artery puncture site using vascular closure device. | intra-procedure | 
| Time to ambulation | The time it takes (unit: hour) to get out of bed and walk at least 6 meters or 20 feet, once completing the closure operation of femoral artery puncture site using vascular closure device. | pre-discharge, estimate to 24 hours post-procedure | 
| Incidence of complications associated with femoral artery access | The complications include: infection associated with the puncture site, bleeding requiring hemostasis treatment associated with the puncture site, hematoma or ecchymosis ≥6cm on the puncture site, haemorrhage and/or bleeding requiring transfusion, pseudoaneurysm, arteriovenous fistula, etc. | 30±7 days post-procedure | 
| Incidence of device deficiency | Device deficiency is the unreasonable risk that may endanger human health and life safety under normal use of medical devices during clinical trials, such as labeling errors, quality problems and malfunctions, etc. | intra-procedure | 
| Incidence of adverse events (AE) | Incidence of adverse events is the proportion of subjects with adverse events using the investigational device or the comparator. | 30±7 days post-procedure | 
| Incidence of serious adverse events (SAE) | Incidence of serious adverse events is the proportion of subjects with serious adverse events using the investigational device or the comparator. | 30±7 days post-procedure |