Transradial Versus Transulnar Artery Approach for Coronary Interventions (AURA)

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
• Conditions: Arterial Access in Percutaneous Coronary Angiography or Intervention
• Intervention / Treatment: Procedure: Transulnar arterial access; Procedure: Transradial arterial access

• Study Type: Interventional
• Enrollment (Anticipated): 572
• Phase: Phase 3

Contacts and Locations

Study Locations

• Greece
  • 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

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transulnar arterial access; Transulnar arterial access for coronary angiography, ad-hoc or elective PCI	Procedure: Transulnar arterial access; 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	Procedure: Transradial arterial access; 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	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	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	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	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)	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

• Sponsor: University of Patras

Publications and helpful links

General 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.

Study record dates

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

• Keywords: percutaneous coronary intervention; transulnar arterial access; transradial arterial access
• Other Study ID Numbers: PATRASCARDIOLOGY-5