NCT05066074

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

Comparison of the Safety and Efficacy Between the Distal and Proximal Radial Vascular Access Technique in Coronary Diagnostic and Therapeutic Procedures

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Instituto Mexicano del Seguro Social · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
PROCEDURE	Distal Radial Vascular Access	Distal Radial Vascular Access

Timeline

• Start date: 2021-08-16
• Primary completion: 2022-03-01
• Completion: 2022-06-01
• First posted: 2021-10-04
• Last updated: 2021-11-24

Locations

1 site across 1 country: Mexico