NCT05822804

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 228 (actual)
• Sponsor: Ton-Bridge Medical Tech. Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Vascular Closure Device (Tonbridge)	Hemostasis treatment for femoral artery puncture with Vascular Closure Device (Tonbridge).
DEVICE	EXOSEAL Vascular Closure Device (Codis Corporation)	Hemostasis treatment for femoral artery puncture with EXOSEAL Vascular Closure Device (Codis Corporation).

Timeline

• Start date: 2023-05-22
• Primary completion: 2024-01-27
• Completion: 2024-03-01
• First posted: 2023-04-21
• Last updated: 2025-07-23

Locations

7 sites across 1 country: China