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

Instituto Mexicano del Seguro Social64 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Coronary Artery Disease

Interventions

Distal Radial Vascular AccessPROCEDURE

Distal Radial Vascular Access

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Instituto Mexicano del Seguro Social

Tijuana, Estado de Baja California, Mexico

Outcomes

Primary Outcomes

Vascular Access Time

Starts when the anesthesia needle contacts the skin and stops when the introducer sheath has been properly placed and flushed.

Time frame: Seconds during the procedure

Secondary Outcomes

"Conventional" Radial Artery Occlusion

Radial Artery Occlusion using vascular ultrasound

Time frame: In the first 24 hours, and follow up to 30 days

Distal Radial Artery Occlusion

Distal Radial Artery Occlusion using vascular ultrasound

Time frame: In the first 24 hours, and follow up to 30 days

Data from ClinicalTrials.gov

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