Safety and Efficacy Between the Distal and Proximal Radial Vascular Access Technique

Not Applicable

• Conditions: Coronary Artery Disease
• Interventions: Procedure: Distal Radial Vascular Access

• Registration Number: NCT05066074
• Lead Sponsor: Instituto Mexicano del Seguro Social

Brief Summary

The investigators are conducting a randomized clinical trial, having as a primary objective, to compare vascular access time between distal and proximal radial approach. Secondary objectives include comparing incidence of distal and proximal radial artery occlusion, at 24 hrs and 30 days. As a tertiary objective investigators will compare the preference of the patients for each access in subsecuent interventional procedures.

Detailed Description

Randomised Clinical Trial / Equivalence Model Permutted block asignation 1:1 Statistical Power 90% and Significance 2.5%. Sample Loss estimation - 15% Chi-square to categorical and T Student to numerical variables. Logistic regression binomial for adverse outcomes. If needed, an intention to treat analysis will be performed.

Study Timeline

• Study Start: 2021-08-16
• Study First Submitted: 2021-09-14
• Study First Submitted QC: 2021-09-23
• Study First Posted: 2021-10-04
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-16
• Last Update Posted: 2021-11-24
• Primary Completion: 2022-03-01
• Study Completion: 2022-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Patients over 18 years
• Clinical indication for coronary angiography / angioplasty
• Palpable radial and distal radial pulse
• Previous clinical Barbeau test
• Radial and distal radial patency via vascular ultrasound
• 24-hour and 30-day follow-up feasibility

Exclusion Criteria

• Previous vascular punctions in the studied anatomic site
• Artery introductor relationship
• Arteriovenous fistula
• Current treatment with oral anticoagulants
• Contraindication for Heparin
• Incomplete medical records
• Vascular access sheath - radial artery mismatch
• Distal radial or ulnar fracture history

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Distal Radial Access	Distal Radial Vascular Access	Distal Radial (Anatomical Snuffbox) Vascular Access prior to catheterization
Proximal Radial Access	Distal Radial Vascular Access	Proximal Radial Vascular Access prior to catheterization

Primary Outcome Measures

Name	Time	Method
Vascular Access Time	Seconds during the procedure	Starts when the anesthesia needle contacts the skin and stops when the introducer sheath has been properly placed and flushed.

Secondary Outcome Measures

Name	Time	Method
Distal Radial Artery Occlusion	In the first 24 hours, and follow up to 30 days	Distal Radial Artery Occlusion using vascular ultrasound
"Conventional" Radial Artery Occlusion	In the first 24 hours, and follow up to 30 days	Radial Artery Occlusion using vascular ultrasound

Trial Locations

Locations (1)

Instituto Mexicano del Seguro Social; 🇲🇽 Tijuana, Baja California, Mexico