Ignite Creation Date:
2025-12-24 @ 11:49 AM
Ignite Modification Date:
2026-01-04 @ 2:29 PM
Study NCT ID:
NCT05496361
Status:
COMPLETED
Last Update Posted:
2022-08-11
First Post:
2022-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective, Multi-center and Randomized Controlled Trial of Tianyi Revascularization Device in Acute Ischemic Stroke
Sponsor:
Suzhou Zenith Vascular Scitech Co., Ltd.
Organization:
Study Overview
Official Title:
A Prospective, Multi-center and Randomized Controlled Clinical Trial to Assess the Safety and Effectiveness of Tianyi Revascularization Device of in the Revascularization of Large Vessel Occlusion in Acute Ischemic Stroke
Status:
COMPLETED
Status Verified Date:
2022-08
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:
This is a prospective, randomized, single blind, concurrent controlled, multi-center study. Patients presenting with symptoms of acute ischemic stroke who have evidence of a large vessel occlusion in the cerebral circulation.
Detailed Description:
This is a prospective, randomized, single blind, concurrent controlled, multi-center study. Patients presenting with symptoms of acute ischemic stroke who have evidence of a large vessel occlusion in the cerebral circulation will be assigned to either the Tianyi Revascularization Device or Solitaire FR Revascularization Device. Each treated patient will be followed and assessed for 3 months after randomization. Up to 238 evaluable patients at up to 18 centers presenting with acute ischemic stroke in vessels accessible to the Revascularization Device for revascularization within 8 hours of symptom onset. The hypothesis to be tested is that the safety and effectiveness of the Tianyi Revascularization Device for the revascularization of large vessel occlusion is not inferior to the Solitaire FR Revascularization Device.
Study Oversight
Has Oversight DMC:
False
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?: