Perfusion and Collaterals Imaging With C-arm CT

NCT ID: NCT03161691

Last Updated: 2018-10-16

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

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-11

Study Completion Date

2019-04-01

Brief Summary

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

Single-center, single-arm pilot study to evaluate the ability of C-arm computed tomography imaging to assess perfusion parameters, collateral vessels, recanalization and brain ischemia in patients with suspected or proven ischemic stroke or brain ischemia in the neuro-angiography suite.

Detailed Description

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

In neurovascular disease, and stroke in particular, physicians often want to be able to detect regions of ischemia in the brain and the recanalization status of cerebral blood vessels. Perfusion and collateral vessel imaging is a possible approach for doing this. These imaging techniques are able to differentiate ischemic core in parenchymal tissue in the brain versus salvageable penumbra tissue around the core. Also the recanalization status of blood vessels can be evaluated using this technique. This study wishes to investigate if the x-ray C-arm in the treatment room can generate perfusion and collateral images of clinical value during treatment, using a technique known as C-arm computed tomography. If this study shows that to be the case, then it might be feasible in the future to bypass CT or MR perfusion/collateral imaging for some patients when they arrive at the hospital, since all this imaging can be done in the treatment room. In the future, this imaging approach may have the potential to simplify and improve patient workflows and reduce the time between hospital arrival and treatment for these patients and could also potentially compensate for missing imaging information.

Conditions

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

Ischemic Stroke

Study Design

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

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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

Ischemic Stroke

Percutaneous neurovascular treatment of acute ischemic stroke patients.

Percutaneous treatment of ischemic stroke

Intervention Type PROCEDURE

An additional C-arm CT imaging scan will be done during neurovascular treatment to evaluate perfusion and collateral vessels in ischemic stroke patients.

Interventions

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

Percutaneous treatment of ischemic stroke

An additional C-arm CT imaging scan will be done during neurovascular treatment to evaluate perfusion and collateral vessels in ischemic stroke patients.

Intervention Type PROCEDURE

Eligibility Criteria

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

Inclusion Criteria

1. Subject has suspected or proven ischemic stroke or brain ischemia.
2. Subject requires diagnostic and/or interventional imaging in the neuro-angiography suite.
3. Subject or subject's legally authorized representative has signed an institutionally approved research informed consent form.
4. Subject ≥ 18 years old.

Exclusion Criteria

1. Subject or subject's legally authorized representative is unable or unwilling to consent to the study.
2. Subject with documented contrast medium injection contraindication due to severe kidney disease or allergy.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Philips Healthcare

INDUSTRY

Sponsor Role collaborator

University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Vitor Pereira

Associate Professor of Radiology and Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Vitor Pereira, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network - Toronto Western Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Toronto Western Hospital - University Health Network

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Canada

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Vitor Pereira, MD

Role: CONTACT

(416) 603 5800 ext. 5564

Alex Kostynskyy, MBBS

Role: CONTACT

416-603-5800 ext. 4806

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Vitor Pereira, MD

Role: primary

(416) 603 5800 ext. 5564

Alex Kostynskyy, MBBS

Role: backup

(416) 603 5800 ext. 4806

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TWH -Ver. 3.0 March 17 2017

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cone Beam CT for Breast Imaging
NCT01880580 COMPLETED