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

Sponsor
Instituto Mexicano del Seguro Social (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05066074
Collaborator
(none)
64
Enrollment
1
Location
2
Arms
9.5
Anticipated Duration (Months)
6.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Distal Radial Vascular Access
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
64 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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: 0Randomised 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
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparison of the Safety and Efficacy Between the Distal and Proximal Radial Vascular Access Technique in Coronary Diagnostic and Therapeutic Procedures
Actual Study Start Date :
Aug 16, 2021
Anticipated Primary Completion Date :
Mar 1, 2022
Anticipated Study Completion Date :
Jun 1, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Vascular Access Time [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 Outcome Measures

    1. "Conventional" Radial Artery Occlusion [In the first 24 hours, and follow up to 30 days]

      Radial Artery Occlusion using vascular ultrasound

    2. Distal Radial Artery Occlusion [In the first 24 hours, and follow up to 30 days]

      Distal Radial Artery Occlusion using vascular ultrasound

    Other Outcome Measures

    1. Quality of life outcome [30-day survey]

      Patient preference for the same access in case a second procedure is needed

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Instituto Mexicano del Seguro Social Tijuana Baja California Mexico 22226

    Sponsors and Collaborators

    • Instituto Mexicano del Seguro Social

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Manuel Alonso Abril Lee, Interventional Cardiology Consultant, Instituto Mexicano del Seguro Social
    ClinicalTrials.gov Identifier:
    NCT05066074
    Other Study ID Numbers:
    • 17 C102 004 049
    First Posted:
    Oct 4, 2021
    Last Update Posted:
    Nov 24, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Manuel Alonso Abril Lee, Interventional Cardiology Consultant, Instituto Mexicano del Seguro Social
    radial artery
    distal radial artery
    vascular access
    radial artery occlusion
    Additional relevant MeSH terms:
    Coronary Artery Disease

    Study Results

    No Results Posted as of Nov 24, 2021