Transradial Versus Transfemoral Arterial Access for Cerebral Angiography

Study Overview
=================
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.

Official Title
-----------------
Transradial Versus Transfemoral Arterial Access for Cerebral Angiography

Conditions
-----------------
Cerebral Angiography

Intervention / Treatment
-----------------
* Procedure: Trans-radial access
* Procedure: Trans-femoral access


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-90 years Planned cerebral angiography for clinical reason Eligible for either transfemoral or transradial approach Accept to sign the written consent form (WCF) Exclusion Criteria: Contraindications to cerebral angiography, such as allergy to iodine contrast agents and renal insufficiency (GFR < 30 ml/min), etc.; Failure to complete the follow-up as required by the protocol; Urgency/Emergency procedure Patients are participating in other clinical trials; Being pregnant or plan to get pregnant in the short term.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trans-radial artery access<br> | Procedure: Trans-radial access<br>* Cerebral angiography performed by trans-radial access<br>|
| Active Comparator: Trans-femoral Artery access<br> | Procedure: Trans-femoral access<br>* Cerebral angiography performed by trans-femoral access<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural success | Finishing cerebral angiography without changing arterial access | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural related complications |  | 24 hours | 
| Total procedure time | time taken to do the full procedure | During procedure | 
| Fluoroscopy time | Radiation time (min) after placing the sheath at the initial puncture site until the completion of the diagnostic cerebral angiography | During procedure | 
| Amount of contrast used | Contrast volume (ml) used during the diagnostic cerebral angiography | During procedure | 
| Costs of cerebral angiography | Cerebral angiography and angiography related nursing expenses | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cerebral Angiography, Transfemoral Arterial access, Transradial Arterial access