Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
Study NCT ID:
NCT07170618
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-12
First Post:
2025-08-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of a New Balloon Microcatheter in the Treatment of Intracranial Artery Stenosis
Sponsor:
Sinomed Neurovita Technology Inc.
Organization:
Study Overview
Official Title:
A Prospective, Multicenter, Objective Performance Criteria Study to Evaluate the Efficacy and Safety of a Balloon Microcatheter for Clinical Use
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: