Transradial Versus Transulnar Artery Approach for Coronary Interventions (AURA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by University of Patras.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Patras
ClinicalTrials.gov Identifier:
NCT01364532
First received: May 27, 2011
Last updated: May 31, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention Phase
Arterial Access in Percutaneous Coronary Angiography or Intervention
Procedure: Transulnar arterial access
Procedure: Transradial arterial access
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Study of Transradial Versus Transulnar Artery Approach for Coronary Interventions

Further study details as provided by University of Patras:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

    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.



Secondary Outcome Measures:
  • Fluoroscopy time [ Time Frame: Fluoroscopy time will be assessed within 1 minute after the end of coronary angiography or coronary intervention ] [ Designated as safety issue: Yes ]
    Fluoroscopy time (in seconds) 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 ] [ Designated as safety issue: No ]
    Volume of contrast medium (ml) 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 ] [ Designated as safety issue: Yes ]
    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

  • 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 ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 572
Study Start Date: April 2011
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01364532

Locations
Greece
Patras University Hospital Recruiting
Patras, Rion, Greece, 26500
Contact: George Hahalis, MD    00306932751222    ghahalis@otenet.gr   
Principal Investigator: George Hahalis, MD         
Sponsors and Collaborators
University of Patras
  More Information

No publications provided by University of Patras

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: George Hahalis, Patras University Hospital
ClinicalTrials.gov Identifier: NCT01364532     History of Changes
Other Study ID Numbers: PATRASCARDIOLOGY-5
Study First Received: May 27, 2011
Last Updated: May 31, 2011
Health Authority: Greece: Ethics Committee

Keywords provided by University of Patras:
transulnar arterial access
transradial arterial access
percutaneous coronary intervention

ClinicalTrials.gov processed this record on September 22, 2014