Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-27 @ 11:56 PM
Study NCT ID:
NCT01054560
Status:
COMPLETED
Last Update Posted:
2016-10-26
First Post:
2009-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
SOLITAIRE™ FR With the Intention For Thrombectomy (SWIFT) Study
Sponsor:
Medtronic Neurovascular Clinical Affairs
Organization:
Study Overview
Official Title:
SOLITAIRE™ FR With the Intention For Thrombectomy (SWIFT) Study
Status:
COMPLETED
Status Verified Date:
2016-08
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:
SWIFT
Brief Summary:
The purpose of this study is to demonstrate substantial equivalence of the SOLITAIRE™ FR Revascularization Device (SOLITAIRE™ Device) with a legally marketed device, MERCI Retrieval System® (MERCI® Device). The study will demonstrate safety and efficacy of the SOLITAIRE™ Device in subjects requiring mechanical thrombectomy diagnosed with acute ischemic stroke.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: