Transradial Versus Transulnar Artery Approach for Coronary Interventions (AURA)
May 31, 2011 updated by: University of Patras
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.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
572
Phase
- Phase 3
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
-
-
Rion
-
Patras, Rion, Greece, 26500
- Recruiting
- Patras University Hospital
-
Contact:
- George Hahalis, MD
- Phone Number: 00306932751222
- Email: ghahalis@otenet.gr
-
Principal Investigator:
- George Hahalis, MD
-
-
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
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age>18 years
- Plan for Coro- and ad hoc PCI, if necessary
- Written informed consent
Exclusion Criteria:
- 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
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Transulnar arterial access
Transulnar arterial access for coronary angiography, ad-hoc or elective PCI
|
Transulnar arterial access in coronary angiography, ad-hoc or elective PCI
|
|
Active Comparator: Transradial arterial access
Transradial arterial access for coronary angiography, ad-hoc or elective PCI
|
Transradial arterial access for coronary angiography,ad-hoc or elective PCI
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
The primary end point will be assessed within 60±5 days after randomization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fluoroscopy time
Time Frame: Fluoroscopy time will be assessed within 1 minute after the end of coronary angiography or coronary intervention
|
Fluoroscopy time (in seconds) assessed within 1 minute after the end of coronary angiography or coronary intervention
|
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
|
Volume of contrast medium (ml) will be assessed within 1 minute after the end of coronary angiography or coronary intervention
|
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
|
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
|
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
|
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
|
Procedural duration will be assessed within 1 minute after the end of coronary angiography or coronary intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
April 1, 2011
Primary Completion (Anticipated)
September 1, 2011
Study Completion (Anticipated)
September 1, 2011
Study Registration Dates
First Submitted
May 27, 2011
First Submitted That Met QC Criteria
May 31, 2011
First Posted (Estimate)
June 2, 2011
Study Record Updates
Last Update Posted (Estimate)
June 2, 2011
Last Update Submitted That Met QC Criteria
May 31, 2011
Last Verified
April 1, 2011
More Information
Terms related to this study
Other Study ID Numbers
- PATRASCARDIOLOGY-5
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