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

NCT ID: NCT05822804

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 228 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-22
• Study Completion Date: 2024-03-01

Brief 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.

Conditions

Vascular Closure; Endovascular Procedure; Hemostasis; Femoral Artery; Puncture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

experimental group

Vascular Closure Device (Tonbridge)

Group Type: EXPERIMENTAL

Vascular Closure Device (Tonbridge)

Intervention Type: DEVICE

Hemostasis treatment for femoral artery puncture with Vascular Closure Device (Tonbridge).

control group

EXOSEAL Vascular Closure Device (Codis Corporation)

Group Type: ACTIVE_COMPARATOR

EXOSEAL Vascular Closure Device (Codis Corporation)

Intervention Type: DEVICE

Hemostasis treatment for femoral artery puncture with EXOSEAL Vascular Closure Device (Codis Corporation).

Interventions

Vascular Closure Device (Tonbridge)

Hemostasis treatment for femoral artery puncture with Vascular Closure Device (Tonbridge).

Intervention Type: DEVICE

EXOSEAL Vascular Closure Device (Codis Corporation)

Hemostasis treatment for femoral artery puncture with EXOSEAL Vascular Closure Device (Codis Corporation).

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ton-Bridge Medical Tech. Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tianxiao Li

Role: PRINCIPAL_INVESTIGATOR

Henan Provincial People's Hospital

Locations

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

Countries

China

Other Identifiers

ZHTQ202204

Identifier Type: -

Identifier Source: org_study_id