Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06289985
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-04
First Post:
2024-02-13
Brief Title:
StrokeNet Thrombectomy Endovascular Platform
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
STEP StrokeNet Thrombectomy Endovascular Platform
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
STEP
Brief Summary:
STEP is a Randomized Multifactorial Adaptive Platform trial that seeks to optimize the care of patients with acute ischemic stroke AIS due to large LVO or medium vessel occlusions MVO
Detailed Description:
The StrokeNet Thrombectomy Endovascular Platform STEP is conducted within NIH StrokeNet at 38 comprehensive stroke centers across the US The primary goal is to optimize all aspects of care of acute ischemic stroke patients with a large or a medium vessel occlusion The platform trial operates under an overarching Master Protocol in an inferentially integrated framework The platform trial is designed to support the studies of three broad categories of therapeutics expansion of endovascular treatment EVT indications innovative EVT devices and concomitant medical therapies and novel pre- and early-hospital technologies and systems of care As new interventions are put forth they will be added to the Master Protocol as a new Domain or part of an existing Domain STEP utilizes a flexible Bayesian design with frequent adaptive analyses to assess whether a given intervention is superior inferior or equivalent either within a Domain or for specific populations within the Domain
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1OT2NS129366-01 | NIH | None | httpsreporternihgovquickSearch1OT2NS129366-01 |