C-arm Cone Beam CT Perfusion Guided Cerebrovascular Interventions

University of Wisconsin (UW)

Status: Completed

Conditions: Acute Ischemic Stroke

Treatments: Diagnostic Test: C-Arm Cone Beam Computed Tomography

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03232151

2015-0482

Protocol Version 3/27/2020 (Other Identifier)

A539300 (Other Identifier)

SMPH\RADIOLOGY\RADIOLOGY (Other Identifier)

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

Details and patient eligibility

About

The overarching objective of our proposal is to develop a One-Stop-Shop imaging using the available C-arm Cone-Beam Computed Tomography (CBCT) data acquisition systems currently widely available worldwide in interventional angiography suites to enable acute ischemic stroke patients to be imaged, triaged, treated, and assessed using a single modality in one room.

Full description

This is an evaluation to determine the efficacy of the use of C-arm CBCT with SMART RECON novel software for the rapid assessment of time-resolved CTA and CT perfusion in the setting of ischemic cerebrovascular events. As a leading center for the treatment of cerebrovascular disease in the Midwest as well as being one of the first Comprehensive Stroke Centers in the United States we have a large potential patient group to assess.

The pilot plan is to compare conventional CT/CTA/CTP acquired during the clinical work up with C-arm CBCT/CTA/CTP acquired in the angiography suite at initiation of therapy. The C-arm CBCT acquisition provides whole brain coverage (compared to only 8 cm brain coverage with conventional CT) with less radiation and higher resolution; the CT perfusion maps obtained using C-arm CBCT and new reconstruction algorithms provides better perfusion maps.

Enrollment: 60 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

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