C-arm Computed Tomography Scan Image Quality in Patients With Neurovascular Diseases

NCT ID: NCT03162601

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

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-04

Study Completion Date

2019-11-01

Brief Summary

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With new developments that have taken place in the optimization of C-arm computed tomography (CACT) image acquisition and reconstruction, CACT image quality will be better than current standard-of-care CACT scan techniques used for neurovascular patients referred to endovascular treatment or diagnosis. As such, novel acquisition, filtration, artifact reduction and reconstruction techniques will be evaluated against the standard-of-care CACT approach.

Detailed Description

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This prospective observational study aims to enroll 50 patients diagnosed with various neurovascular conditions with the goal to compare the image quality of new types of head C-arm computed tomography (CACT) image scans with standard CACT scans, and also to compare these novel scans with standard CT scan image quality. These new scans use novel acquisition, filtration and reconstruction techniques compared to the standard-of-care CACT scans being used in the neuroangiography suite at the present time. Patient selection will be based on a suitability of patients for neuro-endovascular interventions in the neuroangiography suite. All research related activities will be done by study team members. The study patients are expected to follow their routine treatment schedule with the exception of 1 extra CACT scan while patient is receiving their standard treatment.

Conditions

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Endovascular Procedures

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Neurovascular

Patients to receive percutaneous neurovascular intervention

Neurovascular percutaneous intervention

Intervention Type PROCEDURE

Patient will receive one extra CACT scan while they are receiving percutaneous neurovascular intervention.

Interventions

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Neurovascular percutaneous intervention

Patient will receive one extra CACT scan while they are receiving percutaneous neurovascular intervention.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Subject is suitable for an endovascular treatment in the neuro-angiography suite.
2. Subject or subject's legally authorized representative has signed an institutionally approved research informed consent form.
3. 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 had prior significant or severe allergy to intra-arterial contrast medium uncontrolled by pre-procedure medications.
3. Subject with documented contrast injection contraindication due to severe kidney disease or allergy.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Philips Healthcare

INDUSTRY

Sponsor Role collaborator

University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Vitor Pereira

Associate Professor of Radiology and Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vitor Pereira, MD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor of Radiology and Surgery

Locations

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Toronto Western Hospital - University Health Network

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Vitor Pereira, MD

Role: CONTACT

(416) 603 5800 ext. 5564

Alex Kostynskyy, MBBS

Role: CONTACT

416-603-5800 ext. 4806

Facility Contacts

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Vitor Pereira, MD

Role: primary

(416) 603 5800 ext. 5564

Alex Kostynskyy, MBBS

Role: backup

(416) 603 5800 ext. 4806

Other Identifiers

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TWH-Version 2.0 Sept 28 2016

Identifier Type: -

Identifier Source: org_study_id

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