Comparison of the Safety and Efficacy Between the Distal and Proximal Radial Vascular Access Technique in Coronary Diagnostic and Therapeutic Procedures
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Instituto Mexicano del Seguro Social
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Vascular Access Time
- Last Updated
- 4 years ago
Overview
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.
Investigators
Manuel Alonso Abril Lee
Interventional Cardiology Consultant
Instituto Mexicano del Seguro Social
Eligibility Criteria
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
Outcomes
Primary Outcomes
Vascular Access Time
Time Frame: 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 Outcomes
- Distal Radial Artery Occlusion(In the first 24 hours, and follow up to 30 days)
- "Conventional" Radial Artery Occlusion(In the first 24 hours, and follow up to 30 days)