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

Instituto Mexicano del Seguro Social

Status: Unknown

Conditions: Coronary Artery Disease

Treatments: Procedure: Distal Radial Vascular Access

Study type: Interventional

Funder types: Other

Identifiers

NCT05066074

17 C102 004 049

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Distal Radial Access

Experimental group

Description:

Distal Radial (Anatomical Snuffbox) Vascular Access prior to catheterization

Treatment:

Procedure: Distal Radial Vascular Access

Proximal Radial Access

Active Comparator group

Description:

Proximal Radial Vascular Access prior to catheterization

Treatment:

Procedure: Distal Radial Vascular Access