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

November 16, 2021 updated by: Manuel Alonso Abril Lee, Instituto Mexicano del Seguro Social

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Baja California
      • Tijuana, Baja California, Mexico, 22226
        • Instituto Mexicano del Seguro Social

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Distal Radial Access
Distal Radial (Anatomical Snuffbox) Vascular Access prior to catheterization
Procedure: Distal Radial Vascular Access
Distal Radial Vascular Access
Other Names:
  • dTRA
Active Comparator: Proximal Radial Access
Proximal Radial Vascular Access prior to catheterization
Procedure: Distal Radial Vascular Access
Distal Radial Vascular Access
Other Names:
  • dTRA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Seconds during the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
"Conventional" Radial Artery Occlusion
Time Frame: In the first 24 hours, and follow up to 30 days
Radial Artery Occlusion using vascular ultrasound
In the first 24 hours, and follow up to 30 days
Distal Radial Artery Occlusion
Time Frame: In the first 24 hours, and follow up to 30 days
Distal Radial Artery Occlusion using vascular ultrasound
In the first 24 hours, and follow up to 30 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life outcome
Time Frame: 30-day survey
Patient preference for the same access in case a second procedure is needed
30-day survey

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Mexicano del Seguro Social

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 16, 2021

Primary Completion (Anticipated)

March 1, 2022

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

September 14, 2021

First Submitted That Met QC Criteria

September 23, 2021

First Posted (Actual)

October 4, 2021

Study Record Updates

Last Update Posted (Actual)

November 24, 2021

Last Update Submitted That Met QC Criteria

November 16, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17 C102 004 049

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

(planned) March 2022

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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