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

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

NCT05822804•Ton-Bridge Medical Tech. Co., Ltd

View on ClinicalTrials.gov

Summary

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

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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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;
+5 more criteria

Locations (7)

The First Affiliated Hospital of Wannan Medical College

Wuhu, Anhui, China

Nanyang Central Hospital

Nanyang, Henan, China

Puyang Oilfield General Hospital

Puyang, Henan, China

Henan Provincial People's Hospital

Zhengzhou, Henan, China

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

General Hospital of Northern Theater Command

Shenyang, Liaoning, China

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Key Dates

Start Date

May 22, 2023

Primary Completion Date

January 27, 2024

Completion Date

March 1, 2024

Last Updated

July 23, 2025

Enrollment

228

ACTUAL participants

Conditions

Vascular ClosureEndovascular ProcedureHemostasisFemoral ArteryPuncture

Interventions

Vascular Closure Device (Tonbridge)

DEVICE

EXOSEAL Vascular Closure Device (Codis Corporation)

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 23, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Comparison of Efficacy and Safety of Manual Syringing Versus Pneumatic Pressure Bag for Blood Transfusion in Patients Undergoing Cesarean Section With Major Obstetric Hemorrhage

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