Neurovascular diseases Circulatory System
Conditions
Interventions
Permuted block randomization will be performed prior to commencing the study using a block size of 4 subjects (with 2 treatment arms: radial and femoral) using the statistical software StatsDirect Ver
www.statsdirect.com).
The results of the randomization will then be used to create a series of sealed envelopes labelled on the front with the study ID number, and inside containing a
4 additional envelopes created in case of patients who are randomized and then withdraw from the study after group allocation but prior to the procedure). The box containing these envelopes will be ke
Sponsors
University Health Network (Toronto Western Hospital)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged =18 years 2. Referred to the Department of Neuroradiology (UHN) for diagnostic cerebral angiography 3. Ability to give informed written consent to participate in the study, or have a next of kin present (phone consent will not be deemed satisfactory) to give such consent
Exclusion criteria
Exclusion criteria: 1. Aged <18 years 2. Presence of an arterio-venous fistula for hemodialysis over the right upper limb 3. Previous radial artery grafting from the right upper limb for vascular/cardiovascular surgery 4. Known prior dissection or occlusion of the right radial, brachial, or subclavian arteries 5. Known prior severe anaphylactoid reaction to intravascular iodinated contrast injection 6. Known severe uncorrected coagulopathy 7. Inability to give written informed consent or absence of next of kin in the MIDU to give consent for study participation 8. Failed Allen’s test prior to randomization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of procedural success (defined by successful cannulation and angiography of pre-defined vessels based on diagnostic requirements). Efficacy will be assessed via procedural success rates (binary variable) for both groups, with between-group comparison performed using non-inferiority testing (non-inferiority limit of 10% procedural failure). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Visual analogue scale (VAS) assessment of post-procedure pain from the access site, measured 1 h post-procedure. The means for the two groups will be compared using an unpaired t-test (alpha = 0.05). A >10% difference in the mean values of the VAS results between groups would be indicative of significant clinical difference. | — |
Countries
Canada
Contacts
Public ContactVitor Mendes Pereira
Outcome results
None listed