Distal Radial Artery Approach to Prevent Radial Artery Occlusion (DAPRAO)

Study Overview
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Brief Summary
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The main complication of transradial intervention is radial artery occlusion (RAO). This is relevant because it limits the radial approach for future interventions and disables this conduit for coronary bypass grafts and arteriovenous fistula. Observational studies suggest that distal radial access could reduce RAO incidence. The primary endpoint of our study is to compare the efficacy of the distal and proximal transradial approaches in terms of RAO incidence. The safety endpoint is the incidence of complications between these two methods.

Official Title
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Distal Radial Artery Approach to Prevent Radial Artery Occlusion

Conditions
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Radial Artery Occlusion

Intervention / Treatment
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* Procedure: Distal radial artery approach


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Perceptible radial artery pulse Diagnostic or interventional procedure feasible to be performed with radial access. Exclusion Criteria: Myocardial infarction with ST segment elevation in time for primary angioplasty. Cardiogenic shock or hemodynamic instability. Clinical, plethysmography or ultrasound suggestive of occlusion of the radial artery Prior recent radial artery access (1 month)

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two randomized groups, one receiving traditional radial access and the other receiven distal radial access
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Distal radial artery approach<br>Puncture in the snuff box area of the arm with through and through technique, advancement of a wire and placement of an hydrophilic sheath introducer. | Procedure: Distal radial artery approach<br>* Use of distal radial artery approach in coronary angiography and angioplasty<br>|
| Active Comparator: Proximal radial artery approach<br>Puncture in the ventral side of the arm (2 cm proximal to the styloid apophysis) with through and through technique, advancement of a wire and placement of an hydrophilic sheath introducer. | Procedure: Distal radial artery approach<br>* Use of distal radial artery approach in coronary angiography and angioplasty<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint of our study is to compare the efficacy of the distal and proximal transradial approaches in terms of RAO incidence. | The primary endpoint of our study is to compare the efficacy of the distal and proximal transradial approaches in terms of RAO incidence. | The RAO will be evaluated 24 hours after the procedure by ultrasound examination and was defined as the absence of both color pattern and pulsed wave registry. |