C-arm Cone Beam CTP Guided Cerebrovascular Interventions

University of Wisconsin (UW)

Status: Withdrawn

Conditions: Acute Ischemic Stroke

Treatments: Diagnostic Test: C-Arm Cone Beam Computed Tomography; Diagnostic Test: Multi-detector Computed Tomography

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05536895

Protocol Version 10/13/2021 (Other Identifier)

A539300 (Other Identifier)

SMPH\RADIOLOGY\RADIOLOGY (Other Identifier)

1U01EB021183-01 (U.S. NIH Grant/Contract)

2015-0482 Phase 2

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with acute ischemic stroke presenting within 24 hours of onset
2. Patients that present with a large artery occlusion
3. Adults 18 years of age or older.
4. Patients of childbearing potential must not be pregnant.
5. National Institutes of Health Stroke Scale (NIHSS) of <8
6. No severe co-morbidities

Exclusion criteria

1. Patients that are pregnant
2. History of severe renal disease (e.g. stage 4-5)
3. History of renal transplant

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

C-ARM CBCT

Experimental group

Description:

A C-arm CBCT evaluation with SMART RECON novel software for the rapid assessment of time-resolved CT angiogram and CT perfusion.

Treatment:

Diagnostic Test: C-Arm Cone Beam Computed Tomography

MD-CT

Active Comparator group

Description:

An evaluation with conventional, standard of care, multi-detector CT (MD-CT)

Treatment:

Diagnostic Test: Multi-detector Computed Tomography