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

Distal Radial Artery Approach to Prevent Radial Artery Occlusion

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.

Study Overview

• Status: Completed
• Conditions: Radial Artery Occlusion
• Intervention / Treatment: Procedure: Distal radial artery approach

• Study Type: Interventional
• Enrollment (Actual): 282
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Mexico City, Mexico, 14080
    • National Institute of Cardiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Distal radial artery approach; Use of distal radial artery approach in coronary angiography and angioplasty
Active Comparator: 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.	Procedure: Distal radial artery approach; Use of distal radial artery approach in coronary angiography and angioplasty

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Instituto Nacional de Cardiologia Ignacio Chavez

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2019
• Primary Completion (Actual): March 31, 2020
• Study Completion (Actual): March 31, 2020

Study Registration Dates

• First Submitted: January 18, 2020
• First Submitted That Met QC Criteria: January 18, 2020
• First Posted (Actual): January 23, 2020

Study Record Updates

• Last Update Posted (Actual): June 29, 2020
• Last Update Submitted That Met QC Criteria: June 25, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases
• Other Study ID Numbers: INCAR-DG-DI-386-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No