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

NCT04238026 | Completed

• 1 other identifier: INCAR-DG-DI-386-2019
• Study Type: interventional
• Target: 282
• Locations: 1 country
• Sites: 1

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.

Conditions

Radial Artery Occlusion

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Distal radial artery approach

EXPERIMENTAL

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

Proximal radial artery approach

ACTIVE COMPARATOR

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

Interventions

Distal radial artery approach PROCEDURE

Use of distal radial artery approach in coronary angiography and angioplasty

Distal radial artery approach; Proximal radial artery approach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Perceptible radial artery pulse
• Diagnostic or interventional procedure feasible to be performed with radial access.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Instituto Nacional de Cardiologia Ignacio Chavez: lead

Study Sites (1)

National Institute of Cardiology

Mexico City, 14080, Mexico

Location

MeSH Terms

Conditions

Arterial Occlusive Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

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

Study Record Dates

• First Submitted: January 18, 2020
• First Posted: January 23, 2020
• Study Start: May 2, 2019
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: June 29, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share

Locations

ME (1)