NCT06365697

Evaluation of the Ton-bridge Carotid Stent for Carotid Artery Stenosis

Efficacy and Safety of the Ton-bridge Carotid Stent for the Treatment of Carotid Artery Stenosis: a Prospective, Multicenter, Non-inferiority, Randomized Controlled Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 188 (estimated)
• Sponsor: Ton-Bridge Medical Tech. Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to evaluate effectiveness and safety of the Ton-bridge carotid stent for the treatment of carotid artery stenosis.

Detailed description

This is a prospective, multicenter, open-label, non-inferiority, randomized controlled trial carried out in 7 research centers in China. Patients with carotid atherosclerotic stenosis will be randomized (1:1) to either the Ton-bridge carotid stent or WALLSTENT carotid stent for treatment. The purpose of this clinical trial is to evaluate the effectiveness and safety of a novel carotid stent, the Ton-bridge carotid stent, in humans for treatment.

Conditions

• Carotid Artery Stenosis

Interventions

Type	Name	Description
DEVICE	Ton-bridge carotid stent	carotid artery stenting with Ton-bridge carotid stent
DEVICE	WALLSTENT carotid stent	carotid artery stenting with WALLSTENT carotid stent

Timeline

• Start date: 2024-04-24
• Primary completion: 2024-12-11
• Completion: 2026-10-01
• First posted: 2024-04-15
• Last updated: 2026-01-02

Locations

7 sites across 1 country: China