Safety and Efficacy Between the Distal and Proximal Radial Vascular Access Technique

Study Overview
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Brief Summary
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The investigators are conducting a randomized clinical trial, having as a primary objective, to compare vascular access time between distal and proximal radial approach. Secondary objectives include comparing incidence of distal and proximal radial artery occlusion, at 24 hrs and 30 days. As a tertiary objective investigators will compare the preference of the patients for each access in subsecuent interventional procedures.

Detailed Description
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Randomised Clinical Trial / Equivalence Model Permutted block asignation 1:1 Statistical Power 90% and Significance 2.5%. Sample Loss estimation - 15% Chi-square to categorical and T Student to numerical variables. Logistic regression binomial for adverse outcomes. If needed, an intention to treat analysis will be performed.

Official Title
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Comparison of the Safety and Efficacy Between the Distal and Proximal Radial Vascular Access Technique in Coronary Diagnostic and Therapeutic Procedures

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: Distal Radial Vascular Access


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over 18 years Clinical indication for coronary angiography / angioplasty Palpable radial and distal radial pulse Previous clinical Barbeau test Radial and distal radial patency via vascular ultrasound 24-hour and 30-day follow-up feasibility Exclusion Criteria: Previous vascular punctions in the studied anatomic site Artery introductor relationship Arteriovenous fistula Current treatment with oral anticoagulants Contraindication for Heparin Incomplete medical records Vascular access sheath - radial artery mismatch Distal radial or ulnar fracture history

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised Clinical Trial - Equivalence model (Two tailed) Based on a previous pilot study: SD 97 sec Allowable Diff: 90 sec, Patient loss 15%, Type I error 2.5%, Type II error 90% Mean Differences: 0
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Distal Radial Access<br>Distal Radial (Anatomical Snuffbox) Vascular Access prior to catheterization | Procedure: Distal Radial Vascular Access<br>* Distal Radial Vascular Access<br>* Other names: dTRA;|
| Active Comparator: Proximal Radial Access<br>Proximal Radial Vascular Access prior to catheterization | Procedure: Distal Radial Vascular Access<br>* Distal Radial Vascular Access<br>* Other names: dTRA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vascular Access Time | Starts when the anesthesia needle contacts the skin and stops when the introducer sheath has been properly placed and flushed. | Seconds during the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conventional Radial Artery Occlusion | Radial Artery Occlusion using vascular ultrasound | In the first 24 hours, and follow up to 30 days | 
| Distal Radial Artery Occlusion | Distal Radial Artery Occlusion using vascular ultrasound | In the first 24 hours, and follow up to 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radial artery, distal radial artery, vascular access, radial artery occlusion