CB-CT Imaging for Stroke

Overseen By Radiology Studies

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Disqualifiers: Pregnancy, Severe renal disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 visit (up to 120 minutes)

Trial Summary

What is the purpose of this trial?

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.

Research Team

Beverly Aagaard-Kienitz, MD

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

This trial is for adults over 18 with a recent ischemic stroke within the last 24 hours, who have a blockage in a large artery and are not severely ill with other conditions. They must have an NIHSS score of less than 8, indicating mild to moderate stroke severity, and cannot be pregnant or have severe kidney disease.

Inclusion Criteria

No severe co-morbidities

Patients of childbearing potential must not be pregnant

Your National Institutes of Health Stroke Scale (NIHSS) score is less than 8.

Exclusion Criteria

Patients that are pregnant

You have had a kidney transplant in the past.

You have a history of serious kidney disease (e.g. stage 4-5).

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo either C-arm CBCT or MD-CT imaging for the assessment of acute ischemic stroke

1 visit (up to 120 minutes)

Follow-up

Participants are monitored for safety and effectiveness after imaging procedures

4 weeks

Treatment Details

Interventions

• C-arm Cone Beam CTP Guided Cerebrovascular Interventions

Trial Overview The study is testing if using C-arm Cone Beam Computed Tomography (CB-CT) can save substantial time during cerebrovascular interventions by quickly acquiring and reconstructing images for acute ischemic stroke patients compared to standard Multi-detector CT.

Participant Groups

Group I: C-ARM CBCT Experimental Treatment 1 Intervention

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

Group II: MD-CT Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Collaborator

Trials

102

Recruited

21,600+