C-arm Cone Beam CT Perfusion Guided Cerebrovascular Interventions

Not Applicable

Completed

• Conditions: Acute Ischemic Stroke
• Interventions: Diagnostic Test: C-Arm Cone Beam Computed Tomography

• Registration Number: NCT03232151
• Lead Sponsor: University of Wisconsin, Madison

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2017-07-01
• Study First Submitted: 2017-07-18
• Study First Submitted QC: 2017-07-24
• Study First Posted: 2017-07-27
• Primary Completion: 2020-03-26
• Study Completion: 2020-03-26
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-24
• Last Update Posted: 2022-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
C-ARM CBCT	C-Arm Cone Beam Computed Tomography	A C-arm CBCT evaluation with SMART RECON novel software for the rapid assessment of time-resolved CT angiogram and CT perfusion.

Primary Outcome Measures

Name	Time	Method
Percent of C-arm Cone Beam CT scans that detect Hyperemia or Oligemia compared to Standard of Care conventional CT	1 study visit up to 1 hour	To demonstrate device feasibility for phase 2 of this study, the investigators need to demonstrate that the presence of hyperemia or oligemia detected with standard of care conventional CT is also detected to a clinically acceptable degree with C-arm Cone Beam CT.

Secondary Outcome Measures

Name	Time	Method
Optimization of One-Stop-Shop Imaging	Up to 24 months	Data collected will be used to optimize C-arm CBCT imaging parameters, data acquisition methods and contrast dose.
Analysis of Perfusion Parameters from One-Stop-Shop Perfusion Maps	Up to 24 months	Local perfusion parameters on image slices will be measured and compared against the corresponding measurements from diagnostic CTP measurements.
Analysis of ROIs from One-Stop-Shop Perfusion Maps	Up to 24 months	Standard deviations for a variety of regions of interest (ROIs) on image slices will be measured and compared against the corresponding measurements from diagnostic CTP measurements.

Trial Locations

Locations (1)

University of Wisconsin, Madison; 🇺🇸 Madison, Wisconsin, United States