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

Not Applicable

Completed

• Conditions: Radial Artery Occlusion
• Interventions: Procedure: Distal radial artery approach

• Registration Number: NCT04238026
• Lead Sponsor: Instituto Nacional de Cardiologia Ignacio Chavez

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-02
• Study First Submitted: 2020-01-18
• Study First Submitted QC: 2020-01-18
• Study First Posted: 2020-01-23
• Primary Completion: 2020-03-31
• Study Completion: 2020-03-31
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-25
• Last Update Posted: 2020-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 282

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Proximal radial artery approach	Distal 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.
Distal radial artery approach	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.

Primary Outcome Measures

Name	Time	Method
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.	The primary endpoint of our study is to compare the efficacy of the distal and proximal transradial approaches in terms of RAO incidence.

Trial Locations

Locations (1)

National Institute of Cardiology; 🇲🇽 Mexico City, Mexico