Vascular Access ComplicationANTARESNCT05982366
Feasibility and Safety of the Routine Distal Transradial Approach
A study testing distal radial artery acess side and conventional radial artery acess side in people with Vascular Access Complication and Radial Artery, run by Łukasz Koziński at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Access Complication, Radial Artery, Coronary Artery Disease
- What is being tested?
- distal radial artery acess side and conventional radial artery acess side
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 sitePoland
- Study dates
- 1 Nov 2022to 31 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients referred for CAG and/or PCI
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Vascular Access Complication, Radial Artery, Coronary Artery Disease, Puncture, Coronary Angiography
- Being tested
- distal radial artery acess side, conventional radial artery acess side
- Keywords
- radial artery, distal transradial approach, access complication, anatomical snuffbox
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
distal radial artery acess sideOther
Also called dTRA
coronary procedure (coronary angiography and/or coronary angioplasty) by the distal radial artery in the anatomical snuffbox area
conventional radial artery acess sideOther
Also called cTRA
coronary procedure (coronary angiography and/or coronary angioplasty) by the forearm radial artery in the anatomical snuffbox area
| Study group | Role | What they receive |
|---|---|---|
| Distal transradial approach | Experimental | Distal transradial approach as the default strategy Receives: Other: distal radial artery acess side |
| Conventional transradial approach | Active comparator | Conventional transradial approach as the default strategy Receives: Other: conventional radial artery acess side |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 24 hours
Secondary outcomes (4)
efficacy endpoint: rate of access crossover
Access crossover from unsuccessful random arterial access (if the initial access point fails) to another one.
Measured: during the procedure index
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)
Measured: during the procedure
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)
Measured: during the procedure index
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
Measured: after 24 hours post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start1 Nov 2022
- Primary completion28 Feb 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular Access ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, single-center, randomized trial
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Łukasz Koziński
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Łukasz Koziński, Indywidualna Praktyka Lekarska Lekarz Łukasz Koziński
- Investigators
- Łukasz Koziński, MD, Study chair, Indywidualna Praltyka Lekarska Lekarz Łukasz Koziński
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05982366
- Sponsor's protocol ID
- AntaresStudy01
- Acronym
- ANTARES
- Status last verified
- Aug 2023
- First submitted
- 21 Jun 2023
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- distAl vs. coNventional Transradial Access for coRonary procEdures Study (ANTARES)
- ClinicalTrials.gov ID
- NCT05982366
- Acronym / sponsor ID
- ANTARES / AntaresStudy01
- Conditions
- Vascular Access Complication, Radial Artery, Coronary Artery Disease, Puncture, Coronary Angiography
- Keywords
- radial artery, distal transradial approach, access complication, anatomical snuffbox
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Łukasz KozińskiUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 8 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, single-center, randomized trial
| Arm | Type | Receives |
|---|---|---|
| Distal transradial approach | Experimental | Other: distal radial artery acess sideDistal transradial approach as the default strategy |
| Conventional transradial approach | Active comparator | Other: conventional radial artery acess sideConventional transradial approach as the default strategy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients referred for CAG and/or PCI
Key exclusion criteria (8 listed)
- ST-elevation myocardial infarction
- sudden cardiac arrest
- hemody-namic instability
- chronic kidney disease (stages 4-5)
- forearm artery occlusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| distal radial artery acess sideAlso: dTRAcoronary procedure (coronary angiography and/or coronary angioplasty) by the distal radial artery in the anatomical snuffbox area | Other | Distal transradial approach |
| conventional radial artery acess sideAlso: cTRAcoronary procedure (coronary angiography and/or coronary angioplasty) by the forearm radial artery in the anatomical snuffbox area | Other | Conventional transradial approach |
Primary outcome
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.
4 secondary outcomes
efficacy endpoint: rate of access crossover
Time frame: during the procedure index
safety endpoint: patients' discomfort evaluated during access performance
Time frame: during the procedure
efficacy endpoint: duration of access performance
Time frame: during the procedure index
safety endpoint: access-site vascular complications
Time frame: after 24 hours post procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Łukasz Koziński, MD study chair
Indywidualna Praltyka Lekarska Lekarz Łukasz Koziński
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing distal radial artery acess side and conventional radial artery acess side in people with Vascular Access Complication and Radial Artery, run by Łukasz Koziński at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2023.