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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05066074
• Other study ID #: 17 C102 004 049
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 16, 2021
• Est. completion date: June 1, 2022

Study information

• Verified date: November 2021
• Source: Instituto Mexicano del Seguro Social
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 64
• Est. completion date: June 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Procedure:
• Distal Radial Vascular Access
Distal Radial Vascular Access

Locations

Country	Name	City	State
Mexico	Instituto Mexicano del Seguro Social	Tijuana	Baja California

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Mexicano del Seguro Social

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of life outcome	Patient preference for the same access in case a second procedure is needed	30-day survey
Primary	Vascular Access Time	Starts when the anesthesia needle contacts the skin and stops when the introducer sheath has been properly placed and flushed.	Seconds during the procedure
Secondary	"Conventional" Radial Artery Occlusion	Radial Artery Occlusion using vascular ultrasound	In the first 24 hours, and follow up to 30 days
Secondary	Distal Radial Artery Occlusion	Distal Radial Artery Occlusion using vascular ultrasound	In the first 24 hours, and follow up to 30 days