Feasibility and Safety of the Routine Distal Transradial Approach (ANTARES)

August 1, 2023 updated by: Łukasz Koziński

distAl vs. coNventional Transradial Access for coRonary procEdures Study (ANTARES)

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.

Study Overview

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

400

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

    • Pomeranian
      • Chojnice, Pomeranian, Poland, 89-600
        • Szpital Specjalistyczny

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Distal transradial approach
Distal transradial approach as the default strategy
coronary procedure (coronary angiography and/or coronary angioplasty) by the distal radial artery in the anatomical snuffbox area
Other Names:
  • dTRA
Active Comparator: Conventional transradial approach
Conventional transradial approach as the default strategy
coronary procedure (coronary angiography and/or coronary angioplasty) by the forearm radial artery in the anatomical snuffbox area
Other Names:
  • cTRA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary composite endpoint consisted of rate of access crossover, rate of major adverse cardiovascular events (MACE) and rate of access-related vascular complications.
Time Frame: up to 24 hours

Access crossover from unsuccessful random arterial access (if the initial access point fails) to another one.

Access-related complications after the procedure measured with Doppler Ultrasound (included radial artery occlusion, significant hematoma (EASY classification grade III-V), arteriovenous fistula, pseudoaneurysm, perforation and spasm).

MACE definied as myocardial infarction, stroke, urgent revascularization, all-cause death.

up to 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
efficacy endpoint: rate of access crossover
Time Frame: during the procedure index
Access crossover from unsuccessful random arterial access (if the initial access point fails) to another one.
during the procedure index
safety endpoint: patients' discomfort evaluated during access performance
Time Frame: during the procedure
physical discomfort at the time of vascular access performance was assessed using a numerical scale (0/1/2/3 - respectively no/mild/moderate/severe discomfort)
during the procedure
efficacy endpoint: duration of access performance
Time Frame: during the procedure index
(measured from the time of skin puncture with local anesthetic to the successful sheath insertion confirmed by an outflow of arterial blood)
during the procedure index
safety endpoint: access-site vascular complications
Time Frame: after 24 hours post procedure
it is composed by the rate of radial artery occlusion, significant hematoma (EASY classification grade III-V), arteriovenous fistula, pseudoaneurysm, perforation and spasm; measured with Doppler Ultrasound
after 24 hours post procedure

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Access-time
Time Frame: during procedure
counted from local anesthesia to successful insertion of the sheath
during procedure
radial artery size
Time Frame: before the procedure, 24 hours and 60 days after the procedure
parameter measured by Doppler Ultrasound at the access point
before the procedure, 24 hours and 60 days after the procedure
radial artery velocity
Time Frame: before the procedure, 24 hours and 60 days after the procedure
parameter measured by Doppler Ultrasound at the access point
before the procedure, 24 hours and 60 days after the procedure

Collaborators and Investigators

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

Investigators

  • Study Chair: Łukasz Koziński, MD, Indywidualna Praltyka Lekarska Lekarz Łukasz Koziński

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)

November 1, 2022

Primary Completion (Actual)

February 28, 2023

Study Completion (Actual)

May 31, 2023

Study Registration Dates

First Submitted

June 21, 2023

First Submitted That Met QC Criteria

August 1, 2023

First Posted (Actual)

August 8, 2023

Study Record Updates

Last Update Posted (Actual)

August 8, 2023

Last Update Submitted That Met QC Criteria

August 1, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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