Transradial Versus Transulnar Artery Approach for Coronary Interventions (AURA)

University of Patras

Status and phase: Unknown; Phase 3

Conditions: Arterial Access in Percutaneous Coronary Angiography or Intervention

Treatments: Procedure: Transulnar arterial access; Procedure: Transradial arterial access

Study type: Interventional

Funder types: Other

Identifiers

NCT01364532

PATRASCARDIOLOGY-5

Details and patient eligibility

About

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.

Enrollment: 572 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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572 participants in 2 patient groups

Transulnar arterial access

Experimental group

Description:

Transulnar arterial access for coronary angiography, ad-hoc or elective PCI

Treatment:

Procedure: Transulnar arterial access

Transradial arterial access

Active Comparator group

Description:

Transradial arterial access for coronary angiography, ad-hoc or elective PCI

Treatment:

Procedure: Transradial arterial access