Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2025-12-29 @ 1:21 PM
Study NCT ID:
NCT01678495
Status:
COMPLETED
Last Update Posted:
2015-08-10
First Post:
2012-08-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sonothrombolysis Potentiated by Microbubbles for Acute Ischemic Stroke
Sponsor:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Organization:
Study Overview
Official Title:
Sonothrombolysis Potentiated by Microbubbles as a Novel Treatment of Acute Ischemic Stroke: a Prospective Randomized Pilot Study
Status:
COMPLETED
Status Verified Date:
2015-08
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:
It has proposed the use of ST without microbubble treatment in randomized association with both intravenous and intra-arterial thrombolysis, but combined treatment (rtPA + U.S.) associated with MB diagnostic not yet been investigated in a randomized study.
The aim of this study is to evaluate efficacy of the combined treatment (r-rtPA+US+MB) vs the standard rtPA treatment in a randomized study in consecutive patients with acute ischemic stroke.
We expect to demonstrate that the combined treatment (rtPA+US+MB) will be statistically superior to standard treatment in terms of recanalization rate.
The aim of this study is to evaluate efficacy of the combined treatment (r-rtPA+US+MB) vs the standard rtPA treatment in a randomized study in consecutive patients with acute ischemic stroke.
We expect to demonstrate that the combined treatment (rtPA+US+MB) will be statistically superior to standard treatment in terms of recanalization rate.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: