C-arm Cone Beam CT Perfusion Guided Cerebrovascular Interventions

NCT03232151 | Completed DMC FDA Device

• 5 other identifiers: 2015-04821U01EB021183-01A539300SMPH\RADIOLOGY\RADIOLOGYProtocol Version 3/27/2020
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Ischemic Stroke

Keywords

Stroke

Outcome Measures

Primary Outcomes (1)

• Percent of C-arm Cone Beam CT scans that detect Hyperemia or Oligemia compared to Standard of Care conventional CT

  To demonstrate device feasibility for phase 2 of this study, the investigators need to demonstrate that the presence of hyperemia or oligemia detected with standard of care conventional CT is also detected to a clinically acceptable degree with C-arm Cone Beam CT.

  1 study visit up to 1 hour

Secondary Outcomes (3)

• Optimization of One-Stop-Shop Imaging

  Up to 24 months

• Analysis of Perfusion Parameters from One-Stop-Shop Perfusion Maps

  Up to 24 months

• Analysis of ROIs from One-Stop-Shop Perfusion Maps

  Up to 24 months

Study Arms (1)

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

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

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 8 hours of onset
• Patients that present with a large artery occlusion
• Adults 18 years of age or older.
• Women of childbearing potential must not be pregnant.
• National Institutes of Health Stroke Scale (NIHSS) of \>5
• No severe co-morbidities

You may not qualify if:

• Women 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

Condition Hierarchy (Ancestors)

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

Study Officials

• Beverly Aagaard-Kienitz, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single center, open label, single-arm, pilot study

Study Record Dates

• First Submitted: July 18, 2017
• First Posted: July 27, 2017
• Study Start: July 1, 2017
• Primary Completion: March 26, 2020
• Study Completion: March 26, 2020
• Last Updated: May 31, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)