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NCT Number: NCT05982366

Feasibility and Safety of the Routine Distal Transradial Approach

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.

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Key information

Conditions

Vascular Access Complication Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Angiography Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Puncture Radial Artery Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Szpital Specjalistyczny

Chojnice, Pomeranian, 89-600, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

distal radial artery acess side

Other

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

Other names: dTRA

conventional radial artery acess side

Other

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

Other names: cTRA

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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)

  3. 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)

  4. 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

Other outcomes

  1. Access-time

    Time frame: during procedure

    counted from local anesthesia to successful insertion of the sheath

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Łukasz Koziński

Other

Registry information

Official study title

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

Acronym: ANTARES

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 8, 2023
Registry last updated
Aug 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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