Feasibility and Safety of the Routine Distal Transradial Approach

NCT ID: NCT05982366

Last Updated: 2023-08-08

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

COMPLETED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2023-05-31

Brief Summary

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The distal transradial approach (dTRA) via the anatomical snuffbox is hypothesized to be more beneficial than the conventional transradial access (cTRA) in patients undergoing coronary procedures. This prospective single-center randomized trial was designed to investigate the safety, efficacy, and various ultrasound parameters of dTRA.

Detailed Description

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Transradial approach (TRA) has emerged in most countries as a default strategy in urgent and elective coronary procedures. The advantages of TRA compared to the transfemoral access encompass a reduction of mortality, complications, and cost as well as improvement of patient's comfort. The aim of the present study (ANTARES, distAl vs coNventional Transradial Access for coRonary procEdures Study) was to assess the feasibility, safety and various ultrasound parameters of dTRA in the anatomical snuffbox as the first-line strategy, in comparison with cTRA, in patients undergoing coronary angiography (CAG) and percutaneous coronary intervention (PCI). The study is a non-inferiority, randomized controlled trial. There are two arms: distal transradial access and conventional transradial approach.

400 patients were enrolled.

Conditions

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Vascular Access Complication Radial Artery Coronary Artery Disease Puncture Coronary Angiography

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, single-center, randomized trial
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Distal transradial approach

Distal transradial approach as the default strategy

Group Type EXPERIMENTAL

distal radial artery acess side

Intervention Type OTHER

coronary procedure (coronary angiography and/or coronary angioplasty) by the distal radial artery in the anatomical snuffbox area

Conventional transradial approach

Conventional transradial approach as the default strategy

Group Type ACTIVE_COMPARATOR

conventional radial artery acess side

Intervention Type OTHER

coronary procedure (coronary angiography and/or coronary angioplasty) by the forearm radial artery in the anatomical snuffbox area

Interventions

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distal radial artery acess side

coronary procedure (coronary angiography and/or coronary angioplasty) by the distal radial artery in the anatomical snuffbox area

Intervention Type OTHER

conventional radial artery acess side

coronary procedure (coronary angiography and/or coronary angioplasty) by the forearm radial artery in the anatomical snuffbox area

Intervention Type OTHER

Other Intervention Names

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dTRA cTRA

Eligibility Criteria

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Inclusion Criteria

* patients referred for CAG and/or PCI

Exclusion Criteria

* ST-elevation myocardial infarction
* sudden cardiac arrest
* hemody-namic instability
* chronic kidney disease (stages 4-5)
* forearm artery occlusion
* previous unsuccessful ipsilateral TRA
* unfavorable RA diameter
* ultrasound unavailability
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Łukasz Koziński

OTHER

Sponsor Role lead

Responsible Party

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Łukasz Koziński

Principal Investigator Łukasz Koziński, Indywidualna Praktyka Lekarska Lekarz Łukasz Koziński

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Łukasz Koziński, MD

Role: STUDY_CHAIR

Indywidualna Praltyka Lekarska Lekarz Łukasz Koziński

Locations

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Szpital Specjalistyczny

Chojnice, Pomeranian, Poland

Site Status

Countries

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Poland

Other Identifiers

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AntaresStudy01

Identifier Type: -

Identifier Source: org_study_id

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