NCT05593224

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

The Efficacy and Safety of the Intracranial Stent (Tonbridge) in Endovascular Treatment of Intracranial Atherosclerotic Stenosis: A Prospective, Multicenter, Single-Arm Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 156 (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 intracranial atherosclerotic stenosis.

Detailed description

This is a prospective, multicenter, single-arm clinical trial carried out in 14 centers throughout China. 156 subjects with intracranial atherosclerotic stenosis will be treated with the Intracranial Stent (Tonbridge) 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 intracranial atherosclerotic stenosis.

Conditions

• Intracranial Atherosclerosis

Interventions

Type	Name	Description
DEVICE	Intracranial Stent (Tonbridge)	The intracranial stent consists of a self-expanding, laser-carved nickel-titanium stent and its delivery system.

Timeline

• Start date: 2022-11-01
• Primary completion: 2023-11-01
• Completion: 2025-05-01
• First posted: 2022-10-25
• Last updated: 2022-10-25

Locations

14 sites across 1 country: China