Cerebral Angiography
Conditions
Keywords
Cerebral Angiography, Transfemoral Arterial access, Transradial Arterial access
Brief summary
This study is multi-center, prospective, randomized (1:1) controlled trial designed to assess and compare the feasibility, safety and success of Transradial access (TRA) versus Transfemoral access (TFA) for diagnostic cerebral angiography.
Detailed description
TFA is traditional approach for diagnostic cerebral angiography, which has several limitations and complications including pain and discomfort, retroperitoneal hemorrhage, pulmonary embolism and increased admissions. Transradial coronary angiography has demonstrated preponderance to circumvent this limitations and complications. However, this has not been studied in cerebral angiography. So, the purpose of this study is to assess and compare the feasibility, safety and success of TRA versus TFA for diagnostic cerebral angiography.
Interventions
PROCEDURETrans-radial access
Cerebral angiography performed by trans-radial access
PROCEDURETrans-femoral access
Cerebral angiography performed by trans-femoral access
Sponsors
Huashan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 18 and 80 years old; 2. Scheduled to undergo diagnostic cerebral angiography; 3. Suitable for cerebral angiography via TRA and TFA access, with a radial artery diameter ≥2mm confirmed by ultrasonography; 4. Modified Rankin Scale (mRS) score ≤2; 5. Provided written informed consent.
Exclusion criteria
1. Severe stenosis of the radial, brachial, subclavian, brachiocephalic, iliac or common femoral arteries, or any significant vascular disease (such as aortic aneurysm, etc.) that may obstruct guidewire passage; 2. Arteriovenous fistula for hemodialysis present in the right upper limb; 3. Planned interventional surgery within 24 hours of the initial study angiography; 4. Requirement for cerebral angiography in an emergency department; 5. Use of general anesthesia; 6. Any contraindication to cerebral angiography, such as allergy or intolerance to the contrast media, uncorrected severe coagulation disorders, arterial dissection in the target vessel, puncture site infection, or renal insufficiency (Creatinine \[Gr\] \> 3 times of the upper limit of normal \[ULN\]), etc.; 7. Women who are pregnant or planning to become pregnant within 1 year; 8. Participation in another clinical trial; 9. Any other condition deemed unsuitable for participation by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the rate of successful diagnostic cerebral angiography | 24 hours | the successful superselection of the aortic arch vessel without changing the arterial approach, with angiography results meeting diagnostic requirements |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the rate of successful accurate diagnosis | 24 hours | — |
| the duration of angiography | During procedure | time taken to do the full procedure |
| the duration of fluoroscopy | During procedure | Radiation time (min) after placing the sheath at the initial puncture site until the completion of the diagnostic cerebral angiography |
| the bedridden time | 24 hours | — |
| the Visual Analogue Scale (VAS) score | 24 hours | — |
Countries
China
Contacts
Primary ContactHeng Yang, PhD, MD
Outcome results
None listed