Ignite Creation Date:
2025-12-24 @ 12:34 PM
Ignite Modification Date:
2025-12-29 @ 8:40 AM
Study NCT ID:
NCT01657461
Status:
COMPLETED
Last Update Posted:
2017-05-18
First Post:
2012-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Solitaire™ With the Intention For Thrombectomy as PRIMary Endovascular Treatment (SWIFT PRIME) Trial
Sponsor:
Medtronic Neurovascular Clinical Affairs
Organization:
Study Overview
Official Title:
Solitaire™ FR With the Intention For Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke (SWIFT PRIME) Clinical Trial
Status:
COMPLETED
Status Verified Date:
2017-04
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 PRIME
Brief Summary:
The primary study objective is to determine if subjects experiencing an acute ischemic stroke due to large vessel occlusion, treated with combined IV t-PA and Solitaire Revascularization Device within 6 hours of symptom onset have less stroke-related neurological disability (mRS) than those subjects treated with IV t-PA alone
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?: