Arterial Access in Percutaneous Coronary Angiography or InterventionPhase 3AURANCT01364532
Transradial Versus Transulnar Artery Approach for Coronary Interventions
A Phase 3 study testing Transulnar arterial access and Transradial arterial access in people with Arterial Access in Percutaneous Coronary Angiography or Intervention, run by University of Patras at 1 site in Greece.
Trial summary
The transradial route is increasingly used as an access site in percutaneous coronary interventions, as it is considered equivalent to transfemoral approach in terms of efficacy but with a decreased vascular complication risk. Information concerning the efficacy and safety of transulnar approach is sparse. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Arterial Access in Percutaneous Coronary Angiography or Intervention
- What is being tested?
- Transulnar arterial access and Transradial arterial access
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 572 participants
- Where
- 1 siteGreece
- Study dates
- Apr 2011to Sep 2011
- Phase
- Phase 3
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age>18 years
- Plan for Coro- and ad hoc PCI, if necessary
- Written informed consent
Who cannot join
- Cardiogenic shock, haemodynamic instability, Killip class III
- Chronic hemodialysis
- Coronary artery bypass grafting (CABG) with either bilateral internal mammary artery (IMA) or bilateral radial artery use
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Patras University Hospital
Pátrai, Rion, 26500
George Hahalis, MD, 00306932751222, ghahalis@otenet.gr
George Hahalis, MD
About this study
Official title: A Randomized Study of Transradial Versus Transulnar Artery Approach for Coronary Interventions
The transradial route is increasingly used as an access site in percutaneous coronary interventions, as it is considered equivalent to transfemoral approach in terms of efficacy but with a decreased vascular complication risk. Information concerning the efficacy and safety of transulnar approach is sparse. This is a prospective, randomized, investigator-initiated study to compare transradial versus transulnar approach as a default strategy for coronary angiography, ad-hoc or elective percutaneous coronary intervention (PCI). Consecutive eligible patients with an indication for coronary angiography, will be randomized after written informed consent in a 1:1 ratio to either transradial or transulnar access. Assessment of angiographic and procedural characteristics(including amount of contrast medium, arterial access, fluoroscopy and procedural time), as well as any vascular or other peri-procedural complications of the cases enrolled, will be performed. After hospital discharge, all patients will return at Day 60 ±5 days for Doppler ultrasound assessment of the forearm vessels and documentation of major adverse cardiovascular events (defined as death, myocardial infarction, target vessel revascularization and stroke. Coronary angiography patients will be additionally randomized in a 1:1 ratio to either 2500 or 5000 IU of unfractioned heparin.
- Being tested
- Transulnar arterial access, Transradial arterial access
- Keywords
- transulnar arterial access, transradial arterial access, percutaneous coronary intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transulnar arterial accessProcedure or surgery
Transulnar arterial access in coronary angiography, ad-hoc or elective PCI
Transradial arterial accessProcedure or surgery
Transradial arterial access for coronary angiography,ad-hoc or elective PCI
| Study group | Role | What they receive |
|---|---|---|
| Transulnar arterial access | Experimental | Transulnar arterial access for coronary angiography, ad-hoc or elective PCI Receives: Procedure: Transulnar arterial access |
| Transradial arterial access | Active comparator | Transradial arterial access for coronary angiography, ad-hoc or elective PCI Receives: Procedure: Transradial arterial access |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful arterial access free from need for crossover and free from vascular or coronary ischemic complications (MACEs)within 60± days
MACEs are considered both vascular and coronary ischemic complications. Vascular complications include arterial occlusion, local arterial perforation, compartment syndrome, pseudoaneurysm, fistula formation, major bleeding, hematoma of at least 10cm length, or any vascular damage requiring prolonged hospitalization or intervention.
Coronary ishcemic complications include cardiac death, non fatal myocardial infarction, urgent repeat revascularization and stroke.
Measured: The primary end point will be assessed within 60±5 days after randomization
Secondary outcomes (4)
Fluoroscopy time
Fluoroscopy time (in seconds) assessed within 1 minute after the end of coronary angiography or coronary intervention
Measured: Fluoroscopy time will be assessed within 1 minute after the end of coronary angiography or coronary intervention
Amount of contrast medium
Volume of contrast medium (ml) will be assessed within 1 minute after the end of coronary angiography or coronary intervention
Measured: The amount of contrast medium will be assessed within 1 minute after the end of coronary angiography or coronary intervention
Vascular complication defined as post-procedural occlusion, perforation, pseudo-aneurysm, fistula or hematoma formation
Vascular complication (defined as post-procedural occlusion, perforation, pseudo-aneurysm, fistula or hematoma formation of at least 10 cm length, compartment syndrome) will be assessed 6 hours after the end of coronary angiography or intervention
Measured: Vascular complication will be assessed 6 hours after the end of coronary angiography or intervention
Procedural duration (defined as the sum of arterial access, coronary angiography and coronary intervention duration)
Procedural duration (defined as the sum of arterial access, coronary angiography and coronary intervention duration)will be assessed within 1 minute after the end of coronary angiography or coronary intervention
Measured: Procedural duration will be assessed within 1 minute after the end of coronary angiography or coronary intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2011 (estimated)
- Study startApr 2011
- Primary completionSep 2011 (estimated)
- Study completionSep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arterial Access in Percutaneous Coronary Angiography or InterventionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 572 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Patras
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01364532
- Sponsor's protocol ID
- PATRASCARDIOLOGY-5
- Acronym
- AURA
- Status last verified
- Apr 2011
- First submitted
- 27 May 2011
- Last updated
- 2 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Hahalis G, Tsigkas G, Xanthopoulou I, Deftereos S, Ziakas A, Raisakis K, Pappas C, Sourgounis A, Grapsas N, Davlouros P, Galati A, Plakomyti TE, Mylona P, Styliadis I, Pyrgakis V, Alexopoulos D. Transulnar compared with transradial artery approach as a default strategy for coronary procedures: a randomized trial. The Transulnar or Transradial Instead of Coronary Transfemoral Angiographies Study (the AURA of ARTEMIS Study). Circ Cardiovasc Interv. 2013 Jun;6(3):252-61. doi: 10.1161/CIRCINTERVENTIONS.112.000150. Epub 2013 Jun 4.
PubMed 23735472
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of Transradial Versus Transulnar Artery Approach for Coronary Interventions
- ClinicalTrials.gov ID
- NCT01364532
- Acronym / sponsor ID
- AURA / PATRASCARDIOLOGY-5
- Keywords
- transulnar arterial access, transradial arterial access, percutaneous coronary intervention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 572 participants (estimated)
- Lead sponsor
- University of PatrasUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 2 Jun 2011 (estimated)
- 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 transradial route is increasingly used as an access site in percutaneous coronary interventions, as it is considered equivalent to transfemoral approach in terms of efficacy but with a decreased vascular complication risk. Information concerning the efficacy and safety of transulnar approach is sparse. This is a prospective, randomized, investigator-initiated study to compare transradial versus transulnar approach as a default strategy for coronary angiography, ad-hoc or elective percutaneous coronary intervention (PCI). Consecutive eligible patients with an indication for coronary angiography, will be randomized after written informed consent in a 1:1 ratio to either transradial or transulnar access. Assessment of angiographic and procedural characteristics(including amount of contrast medium, arterial access, fluoroscopy and procedural time), as well as any vascular or other peri-procedural complications of the cases enrolled, will be performed. After hospital discharge, all patients will return at Day 60 ±5 days for Doppler ultrasound assessment of the forearm vessels and documentation of major adverse cardiovascular events (defined as death, myocardial infarction, target vessel revascularization and stroke. Coronary angiography patients will be additionally randomized in a 1:1 ratio to either 2500 or 5000 IU of unfractioned heparin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transulnar arterial access | Experimental | Procedure: Transulnar arterial accessTransulnar arterial access for coronary angiography, ad-hoc or elective PCI |
| Transradial arterial access | Active comparator | Procedure: Transradial arterial accessTransradial arterial access for coronary angiography, ad-hoc or elective PCI |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age>18 years
- Plan for Coro- and ad hoc PCI, if necessary
- Written informed consent
Key exclusion criteria (3 listed)
- Cardiogenic shock, haemodynamic instability, Killip class III
- Chronic hemodialysis
- Coronary artery bypass grafting (CABG) with either bilateral internal mammary artery (IMA) or bilateral radial artery use
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 |
|---|---|---|
| Transulnar arterial accessTransulnar arterial access in coronary angiography, ad-hoc or elective PCI | Procedure or surgery | Transulnar arterial access |
| Transradial arterial accessTransradial arterial access for coronary angiography,ad-hoc or elective PCI | Procedure or surgery | Transradial arterial access |
Primary outcome
Successful arterial access free from need for crossover and free from vascular or coronary ischemic complications (MACEs)within 60± days
Time frame: The primary end point will be assessed within 60±5 days after randomization
MACEs are considered both vascular and coronary ischemic complications. Vascular complications include arterial occlusion, local arterial perforation, compartment syndrome, pseudoaneurysm, fistula formation, major bleeding, hematoma of at least 10cm length, or any vascular damage requiring prolonged hospitalization or intervention. Coronary ishcemic complications include cardiac death, non fatal myocardial infarction, urgent repeat revascularization and stroke.
4 secondary outcomes
Fluoroscopy time
Time frame: Fluoroscopy time will be assessed within 1 minute after the end of coronary angiography or coronary intervention
Amount of contrast medium
Time frame: The amount of contrast medium will be assessed within 1 minute after the end of coronary angiography or coronary intervention
Vascular complication defined as post-procedural occlusion, perforation, pseudo-aneurysm, fistula or hematoma formation
Time frame: Vascular complication will be assessed 6 hours after the end of coronary angiography or intervention
Procedural duration (defined as the sum of arterial access, coronary angiography and coronary intervention duration)
Time frame: Procedural duration will be assessed within 1 minute after the end of coronary angiography or coronary intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2011.
- Derived from this study: PubMed 23735472Hahalis G, Tsigkas G, Xanthopoulou I, Deftereos S, Ziakas A, Raisakis K, Pappas C, Sourgounis A, Grapsas N, Davlouros P, Galati A, Plakomyti TE, Mylona P, Styliadis I, Pyrgakis V, Alexopoulos D. Transulnar compared with transradial artery approach as a default strategy for coronary procedures: a randomized trial. The Transulnar or Transradial Instead of Coronary Transfemoral Angiographies Study (the AURA of ARTEMIS Study). Circ Cardiovasc Interv. 2013 Jun;6(3):252-61. doi: 10.1161/CIRCINTERVENTIONS.112.000150. Epub 2013 Jun 4.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Transulnar arterial access and Transradial arterial access in people with Arterial Access in Percutaneous Coronary Angiography or Intervention, run by University of Patras at 1 site in Greece.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 2 Jun 2011. 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 Greece. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful arterial access free from need for crossover and free from vascular or coronary ischemic complications (MACEs)within 60± days (time frame: The primary end point will be assessed within 60±5 days after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01364532, which also lists 1 linked publication.
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 2 Jun 2011.