C-arm Cone Beam CTP Guided Cerebrovascular Interventions

NCT05536895 | Withdrawn DMC FDA Device

• 5 other identifiers: 2015-0482 Phase 21U01EB021183-01A539300SMPH\RADIOLOGY\RADIOLOGYProtocol Version 10/13/2021
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Ischemic Stroke

Keywords

Stroke

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

C-ARM CBCT

EXPERIMENTAL

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

Diagnostic Test: C-Arm Cone Beam Computed Tomography

MD-CT

ACTIVE COMPARATOR

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

Diagnostic Test: Multi-detector Computed Tomography

Interventions

C-Arm Cone Beam Computed Tomography DIAGNOSTIC_TEST

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.

Also known as: C-ARM CBCT

C-ARM CBCT

Multi-detector Computed Tomography DIAGNOSTIC_TEST

Conventional, standard of care perfusion imaging for AIS

Also known as: MD-CT

MD-CT

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with acute ischemic stroke presenting within 24 hours of onset
• Patients that present with a large artery occlusion
• Adults 18 years of age or older.
• Patients of childbearing potential must not be pregnant.
• National Institutes of Health Stroke Scale (NIHSS) of \<8
• No severe co-morbidities

You may not qualify if:

• Patients that are pregnant
• History of severe renal disease (e.g. stage 4-5)
• History of renal transplant

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institute for Biomedical Imaging and Bioengineering (NIBIB): collaborator

Study Sites (1)

University of Wisconsin, Madison

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Interventions

Multidetector Computed Tomography

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tomography, Spiral Computed; Tomography, X-Ray Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Officials

• Beverly Aagaard-Kienitz, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single center, randomized controlled trial

Study Record Dates

• First Submitted: September 8, 2022
• First Posted: September 13, 2022
• Study Start: March 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)