C-arm Cone Beam CTP Guided Cerebrovascular Interventions

Not Applicable

Withdrawn

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

• Registration Number: NCT05536895
• Lead Sponsor: University of Wisconsin, Madison

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-09-08
• Study First Submitted QC: 2022-09-08
• Study First Posted: 2022-09-13
• Study Start: 2025-03
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-04
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MD-CT	Multi-detector Computed Tomography	An evaluation with conventional, standard of care, multi-detector CT (MD-CT)
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
Feasibility measured as the amount of time from hospital arrival to the angiography suite	1 visit (up to 120 minutes)	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.

Trial Locations

Locations (1)

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