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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

282 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-02

Study Completion Date

2020-03-31

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.

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Detailed Description

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Conditions

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Radial Artery Occlusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two randomized groups, one receiving traditional radial access and the other receiven distal radial access

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Distal radial artery approach

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.

Group Type EXPERIMENTAL

Distal radial artery approach

Intervention Type PROCEDURE

Use of distal radial artery approach in coronary angiography and angioplasty

Proximal radial artery approach

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.

Group Type ACTIVE_COMPARATOR

Distal radial artery approach

Intervention Type PROCEDURE

Use of distal radial artery approach in coronary angiography and angioplasty

Interventions

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Distal radial artery approach

Use of distal radial artery approach in coronary angiography and angioplasty

Intervention Type PROCEDURE

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No