Ignite Creation Date:
2024-05-06 @ 3:45 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04749251
Status:
COMPLETED
Last Update Posted:
2022-06-13
First Post:
2021-01-29
Brief Title:
IDEAL Blood Pressure Management During Endovascular Therapy for Acute Ischemic Stroke
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
IDEAL Blood Pressure Management During Endovascular Therapy for Acute Ischemic StrokeA Feasibility Study of Randomisation to Individual vs Fixed Blood Pressure Targets During Endovascular Therapy for Acute Ischemic Stroke
Status:
COMPLETED
Status Verified Date:
2021-01
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:
IDEAL
Brief Summary:
The ideal blood pressure management strategy during endovascular therapy EVT for acute ischemic stroke has not been defined The aim of this pilot randomized clinical trial is to determine whether randomization to a standard versus individual blood pressure management strategy during the EVT procedure is feasible
Detailed Description:
Acute ischemic stroke AIS is a leading cause of death and long-term disability in the Western world Catheter-based removal of blood clots endovascular therapy-EVT is now the standard of care for AIS caused by large vessel occlusions in the brain The level of blood pressure during the procedure appears to influence outcome However optimal blood pressure management strategy has not been determined Current blood pressure management strategy during EVT typically aims to maintain blood pressure above or within predefined fixed targets and is based on observational data and expert consensus rather than on high-quality randomized evidence Should blood pressure during removal of the occlusion be managed according to the patients individual blood pressure level or according to predefined fixed blood pressure targets The primary aim of this pilot trial is to determine whether randomization to a procedure strategy targeting a predefined mean arterial blood pressure MABP of 70-90 mmHg versus an individual strategy targeting 10 of a MABP reference value is feasible Secondary aims are to test recruitability and to detect challenges or obstacles that would call for changes in the study design
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?:
None