Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2026-01-05 @ 4:51 PM
Study NCT ID:
NCT05536895
Status:
WITHDRAWN
Last Update Posted:
2025-04-04
First Post:
2022-09-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
C-arm Cone Beam CTP Guided Cerebrovascular Interventions
Sponsor:
University of Wisconsin, Madison
Organization:
Study Overview
Official Title:
C-arm Cone Beam CTP Guided Cerebrovascular Interventions: Evaluating Predictability and Accuracy for the Treatment of Acute Cerebral Ischemia in the Angiography Suite
Status:
WITHDRAWN
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
There is now a commercially available product, the evidence from this study is no longer required to justify adoption of perfusion imaging in the angio suite.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study objective for the Phase 2 of this research is to demonstrate and confirm the substantial time savings that can be obtained using cone beam computed tomography (CB-CT) for both complete image acquisition and rapid image reconstruction in a Direct to Angio paradigm (One Stop Shop) for selected acute ischemic stroke (AIS) patients.
Detailed Description:
Phase 2 of this research is aimed at validating the feasibility and time savings of bringing selected acute ischemic stroke patients with suspected large vessel occlusion directly on hospital arrival to the angiography suite, avoiding the emergency room and conventional MD-CT imaging. In order to make this phase of the study more robust and to reduce bias on image assessment we will prospectively randomize the patients in a 2:1 fashion to either direct to angio for CB-CT imaging or MD-CT imaging in the emergency room. A total of 60 CB-CT subjects and 30 MD-CT subjects will comprise this cohort. Entrance criteria will be identical to those in Phase 1, except the NIHSS must be greater than 8 which is clinically correlative with a likely large vessel occlusion and, since this is standard of care imaging for acute ischemic stroke, GFR will be removed as an exclusionary criteria.
The Phase 1 of this research was registered to NCT03232151.
The Phase 1 of this research was registered to NCT03232151.
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1U01EB021183-01 | NIH | None | https://reporter.nih.gov/quic… | View |
| A539300 | OTHER | UW Madison | View | |
| SMPH\RADIOLOGY\RADIOLOGY | OTHER | UW Madison | View | |
| Protocol Version 10/13/2021 | OTHER | UW Madison | View |