Recruiting

Observational Study

Sponsor:

University Health Network, Toronto

Code:

NCT03162601

Conditions

Endovascular Procedures

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Neurovascular percutaneous intervention

Study Details

Brief summary:

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.

Conditions

Endovascular Procedures

Study ID

NCT03162601

Start date

Apr 4, 2017

Status verified date

Oct, 2018

Completion date

Nov 1, 2019

Anticipated

Primary completion date

Nov 1, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Neurovascular

Patients to receive percutaneous neurovascular intervention

Interventions

Neurovascular percutaneous intervention

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

Primary outcome measure

  • Number of participants with improved new CACT image quality compared to standard CACT based on a 5-point Likert scale [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Locations

Toronto Western Hospital - University Health Network

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contacts

Principal Investigator:

Vitor Pereira, MD

More Information

Sponsor

University Health Network, Toronto

Last update posted

Oct 16, 2018

Last verified

Oct, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2018-10-16.