C-arm Cone Beam CT Perfusion Guided Cerebrovascular Interventions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2020-03-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Personalization of CM Injection Protocols in Coronary Computed Tomographic Angiography

NCT03292354

Coronary Artery Calcification Cardiac Disease

COMPLETED NA

Determining the Impact of Shunting and CerebroVascular Reactivity on 7T MRI (DISCoVeR 7T MRI)

NCT03291340

Cognitive Impairment

COMPLETED

Imaging of Vulnerable Plaques in Coronary Artery Disease by Multidetector Computed Tomography

NCT00482651

Atherosclerosis

COMPLETED NA

Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease

NCT03622359

Peripheral Artery Disease Diabetes Mellitus Chronic Limb-Threatening Ischemia

RECRUITING NA

Prospective Multicenter Registry On Radiation Dose Estimates Of Cardiac CT Angiography in Daily Practice in 2017 (PROTECTION VI)

NCT03253692

Arteriosclerosis Coronary Artery Disease Coronary Disease +2 more

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is an evaluation to determine the efficacy of the use of C-arm CBCT with SMART RECON novel software for the rapid assessment of time-resolved CTA and CT perfusion in the setting of ischemic cerebrovascular events. As a leading center for the treatment of cerebrovascular disease in the Midwest as well as being one of the first Comprehensive Stroke Centers in the United States we have a large potential patient group to assess.

The pilot plan is to compare conventional CT/CTA/CTP acquired during the clinical work up with C-arm CBCT/CTA/CTP acquired in the angiography suite at initiation of therapy. The C-arm CBCT acquisition provides whole brain coverage (compared to only 8 cm brain coverage with conventional CT) with less radiation and higher resolution; the CT perfusion maps obtained using C-arm CBCT and new reconstruction algorithms provides better perfusion maps.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Ischemic Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single center, open label, single-arm, pilot study

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

C-ARM CBCT

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

Group Type EXPERIMENTAL

C-Arm Cone Beam Computed Tomography

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

C-ARM CBCT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Patients with acute ischemic stroke presenting within 8 hours of onset
2. Patients that present with a large artery occlusion
3. Adults 18 years of age or older.
4. Women of childbearing potential must not be pregnant.
5. National Institutes of Health Stroke Scale (NIHSS) of \>5
6. No severe co-morbidities