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

NCT ID: NCT05066074

Last Updated: 2021-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-16

Study Completion Date

2022-06-01

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease

Keywords

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radial artery distal radial artery vascular access radial artery occlusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Distal Radial Access

Distal Radial (Anatomical Snuffbox) Vascular Access prior to catheterization

Group Type EXPERIMENTAL

Distal Radial Vascular Access

Intervention Type PROCEDURE

Distal Radial Vascular Access

Proximal Radial Access

Proximal Radial Vascular Access prior to catheterization

Group Type ACTIVE_COMPARATOR

Distal Radial Vascular Access

Intervention Type PROCEDURE

Distal Radial Vascular Access

Interventions

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Distal Radial Vascular Access

Distal Radial Vascular Access

Intervention Type PROCEDURE

Other Intervention Names

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dTRA

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto Mexicano del Seguro Social

OTHER_GOV

Sponsor Role lead

Responsible Party

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Manuel Alonso Abril Lee

Interventional Cardiology Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Instituto Mexicano del Seguro Social

Tijuana, Estado de Baja California, Mexico

Site Status

Countries

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Mexico

Other Identifiers

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17 C102 004 049

Identifier Type: -

Identifier Source: org_study_id