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

NCT05066074 | Unknown

• 1 other identifier: 17 C102 004 049
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

radial artery; distal radial artery; vascular access; radial artery occlusion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• "Conventional" Radial Artery Occlusion

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

• Distal Radial Artery Occlusion

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

Other Outcomes (1)

• Quality of life outcome

  30-day survey

Study Arms (2)

Distal Radial Access

EXPERIMENTAL

Distal Radial (Anatomical Snuffbox) Vascular Access prior to catheterization

Procedure: Distal Radial Vascular Access

Proximal Radial Access

ACTIVE COMPARATOR

Proximal Radial Vascular Access prior to catheterization

Procedure: Distal Radial Vascular Access

Interventions

Distal Radial Vascular Access PROCEDURE

Distal Radial Vascular Access

Also known as: dTRA

Distal Radial Access; Proximal Radial Access

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• hour and 30-day follow-up feasibility

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead

Study Sites (1)

Instituto Mexicano del Seguro Social

Tijuana, Estado de Baja California, 22226, Mexico

Location

MeSH Terms

Conditions

Coronary Artery Disease; Arterial Occlusive Diseases

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Interventional Cardiology Consultant

Model Details: Randomised Clinical Trial - Equivalence model (Two tailed) Based on a previous pilot study: SD 97 sec Allowable Diff: 90 sec, Patient loss 15%, Type I error 2.5%, Type II error 90% Mean Differences: 0

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: October 4, 2021
• Study Start: August 16, 2021
• Primary Completion: March 1, 2022
• Study Completion: June 1, 2022
• Last Updated: November 24, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: (planned) March 2022

Locations

ME (1)