NCT07170618

Efficacy and Safety of a New Balloon Microcatheter in the Treatment of Intracranial Artery Stenosis

A Prospective, Multicenter, Objective Performance Criteria Study to Evaluate the Efficacy and Safety of a Balloon Microcatheter for Clinical Use

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Sinomed Neurovita Technology Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this trial is to evaluate the safety and efficacy of a new balloon microcatheter in patients with intracranial artery stenosis.

Detailed description

This study is a prospective, multicenter, objective performance criteria clinical trial to evaluate the safety and efficacy of a balloon microcatheter in the treatment of intracranial artery stenosis. A total of 56 patients are planned to be included. The endpoints include device success, target vessel dissection, target vessel occlusion, mortality and cerebrovascular events, assessed during the in-hospital until discharge.

Conditions

• Intracranial Artery Stenosis

Interventions

Type	Name	Description
DEVICE	balloon microcatheter	The balloon microcatheter simultaneously possesses both balloon dilatation and device delivery functions.

Timeline

• Start date: 2025-09-01
• Primary completion: 2025-12-30
• Completion: 2025-12-30
• First posted: 2025-09-12
• Last updated: 2025-09-12

Locations

1 site across 1 country: China