C-arm Cone Beam CTP Guided Cerebrovascular Interventions

Acute Ischemic Stroke Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05536895
• Other study ID #: 2015-0482 Phase 2
• Secondary ID: 1U01EB021183-01A
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2024
• Est. completion date: April 2025

Study information

• Verified date: March 2024
• Source: University of Wisconsin, Madison
• Contact: Gemma Gliori, MS
• Phone: 608-262-7269
• Email: ggliori[@]uwhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemic Stroke

Intervention

Diagnostic Test:
• C-Arm Cone Beam Computed Tomography
C-ARM CBCT angiogram and CBCT perfusion imaging using prototype software (SMART-RECON) can rapidly and accurately assess the cerebral blood flow maps in the setting of decreased blood flow to the brain (ischemic cerebrovascular events). This rapid assessment would eliminate the need for the patient to be imaged in another scanner and be subsequently transported again to another room; all anatomic and physiologic imaging would occur in the angiography suite.
• Multi-detector Computed Tomography
Conventional, standard of care perfusion imaging for AIS

Locations

Country	Name	City	State
United States	University of Wisconsin, Madison	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility measured as the amount of time from hospital arrival to the angiography suite	Phase 2 of the human subject study aims to further assess the feasibility as a measure the amount of time it takes to bring 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.	1 visit (up to 120 minutes)