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

Primary Purpose

Vascular Access Complication, Radial Artery, Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
distal radial artery acess side
conventional radial artery acess side
Sponsored by
Łukasz Koziński
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Vascular Access Complication focused on measuring radial artery, distal transradial approach, access complication, anatomical snuffbox

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Szpital Specjalistyczny

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Distal transradial approach

Conventional transradial approach

Arm Description

Distal transradial approach as the default strategy

Conventional transradial approach as the default strategy

Outcomes

Primary Outcome Measures

The primary composite endpoint consisted of rate of access crossover, rate of major adverse cardiovascular events (MACE) and rate of access-related vascular complications.
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 Outcome Measures

efficacy endpoint: rate of access crossover
Access crossover from unsuccessful random arterial access (if the initial access point fails) to another one.
safety endpoint: patients' discomfort evaluated during access performance
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)
efficacy endpoint: duration of access performance
(measured from the time of skin puncture with local anesthetic to the successful sheath insertion confirmed by an outflow of arterial blood)
safety endpoint: access-site vascular complications
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

Full Information

First Posted
June 21, 2023
Last Updated
August 1, 2023
Sponsor
Łukasz Koziński
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1. Study Identification

Unique Protocol Identification Number
NCT05982366
Brief Title
Feasibility and Safety of the Routine Distal Transradial Approach
Acronym
ANTARES
Official Title
distAl vs. coNventional Transradial Access for coRonary procEdures Study (ANTARES)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
May 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Łukasz Koziński

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Access Complication, Radial Artery, Coronary Artery Disease, Puncture, Coronary Angiography
Keywords
radial artery, distal transradial approach, access complication, anatomical snuffbox

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, single-center, randomized trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Distal transradial approach
Arm Type
Experimental
Arm Description
Distal transradial approach as the default strategy
Arm Title
Conventional transradial approach
Arm Type
Active Comparator
Arm Description
Conventional transradial approach as the default strategy
Intervention Type
Other
Intervention Name(s)
distal radial artery acess side
Other Intervention Name(s)
dTRA
Intervention Description
coronary procedure (coronary angiography and/or coronary angioplasty) by the distal radial artery in the anatomical snuffbox area
Intervention Type
Other
Intervention Name(s)
conventional radial artery acess side
Other Intervention Name(s)
cTRA
Intervention Description
coronary procedure (coronary angiography and/or coronary angioplasty) by the forearm radial artery in the anatomical snuffbox area
Primary Outcome Measure Information:
Title
The primary composite endpoint consisted of rate of access crossover, rate of major adverse cardiovascular events (MACE) and rate of access-related vascular complications.
Description
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.
Time Frame
up to 24 hours
Secondary Outcome Measure Information:
Title
efficacy endpoint: rate of access crossover
Description
Access crossover from unsuccessful random arterial access (if the initial access point fails) to another one.
Time Frame
during the procedure index
Title
safety endpoint: patients' discomfort evaluated during access performance
Description
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)
Time Frame
during the procedure
Title
efficacy endpoint: duration of access performance
Description
(measured from the time of skin puncture with local anesthetic to the successful sheath insertion confirmed by an outflow of arterial blood)
Time Frame
during the procedure index
Title
safety endpoint: access-site vascular complications
Description
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
Time Frame
after 24 hours post procedure
Other Pre-specified Outcome Measures:
Title
Access-time
Description
counted from local anesthesia to successful insertion of the sheath
Time Frame
during procedure
Title
radial artery size
Description
parameter measured by Doppler Ultrasound at the access point
Time Frame
before the procedure, 24 hours and 60 days after the procedure
Title
radial artery velocity
Description
parameter measured by Doppler Ultrasound at the access point
Time Frame
before the procedure, 24 hours and 60 days after the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Łukasz Koziński, MD
Organizational Affiliation
Indywidualna Praltyka Lekarska Lekarz Łukasz Koziński
Official's Role
Study Chair
Facility Information:
Facility Name
Szpital Specjalistyczny
City
Chojnice
State/Province
Pomeranian
ZIP/Postal Code
89-600
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No

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Feasibility and Safety of the Routine Distal Transradial Approach

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