NCT05757505

The Efficacy and Safety of Intracranial Stent (Tonbridge) in Endovascular Treatment of Symptomatic Intracranial Atherosclerotic Stenosis

The Efficacy and Safety of the Intracranial Stent (Tonbridge) in Endovascular Treatment of Symptomatic Intracranial Atherosclerotic Stenosis: A Prospective, Multicenter, Randomized Controlled, Non-inferiority Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Ton-Bridge Medical Tech. Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to verify the efficacy and safety of the Intracranial Stent (Tonbridge) in endovascular treatment of symptomatic intracranial atherosclerotic stenosis.

Detailed description

This is a prospective, multicenter, randomized controlled, non-inferiority clinical trial carried out in 13 centers throughout China. 200 subjects with symptomatic intracranial atherosclerotic stenosis will be treated with the Intracranial Stent (Zhuhai Tonbridge Medical Tech. Co., Ltd.) or the Wingspan Stent System (Stryker Neurovascular) for the expansion of vascular stenosis site. The primary objective of this study is to evaluate the effectiveness and safety of the intracranial stent for endovascular treatment of symptomatic intracranial atherosclerotic stenosis.

Conditions

• Intracranial Atherosclerosis

Interventions

Type	Name	Description
DEVICE	Intracranial Stent (Tonbridge)	Endovascular treatment with Intracranial Stent (Tonbridge).
DEVICE	Wingspan Stent System (Stryker Neurovascular)	Endovascular treatment with Wingspan Stent System (Stryker Neurovascular).

Timeline

• Start date: 2023-05-11
• Primary completion: 2026-01-01
• Completion: 2026-12-01
• First posted: 2023-03-07
• Last updated: 2026-01-02

Locations

13 sites across 1 country: China