Clinical trial NCT03232151: C-arm Cone Beam CT Perfusion Guided Cerebrovascular Interventions
Official title: C-arm Cone Beam CT Perfusion Guided Cerebrovascular Interventions Evaluating Predictability and Accuracy for the Treatment of Acute Cerebral Ischemia in the Angiography Suite
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Ischemic Stroke
Keywords: Stroke
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
First posted: 2017-07-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single center, open label, single-arm, pilot study
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent of C-arm Cone Beam CT scans that detect Hyperemia or Oligemia compared to Standard of Care conventional CT
timeFrame: 1 study visit up to 1 hour
Secondary outcomes:
measure: Optimization of One-Stop-Shop Imaging
timeFrame: Up to 24 months
measure: Analysis of Perfusion Parameters from One-Stop-Shop Perfusion Maps
timeFrame: Up to 24 months
measure: Analysis of ROIs from One-Stop-Shop Perfusion Maps
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin, Madison
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Beverly Aagaard-Kienitz, MD
role: PRINCIPAL_INVESTIGATOR
References: