Clinical trial NCT01364532: Transradial Versus Transulnar Artery Approach for Coronary Interventions
Official title: A Randomized Study of Transradial Versus Transulnar Artery Approach for Coronary Interventions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Arterial Access in Percutaneous Coronary Angiography or Intervention
Keywords: transulnar arterial access
transradial arterial access
percutaneous coronary intervention
Lead sponsor: University of Patras
Sponsor class: OTHER
First posted: 2011-06-02
Enrollment: 572
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility 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

Primary outcomes:
measure: Successful arterial access free from need for crossover and free from vascular or coronary ischemic complications (MACEs)within 60± days
timeFrame: The primary end point will be assessed within 60±5 days after randomization
Secondary outcomes:
measure: Fluoroscopy time
timeFrame: Fluoroscopy time will be assessed within 1 minute after the end of coronary angiography or coronary intervention
measure: Amount of contrast medium
timeFrame: The amount of contrast medium will be assessed within 1 minute after the end of coronary angiography or coronary intervention
measure: Vascular complication defined as post-procedural occlusion, perforation, pseudo-aneurysm, fistula or hematoma formation
timeFrame: Vascular complication will be assessed 6 hours after the end of coronary angiography or intervention
measure: Procedural duration (defined as the sum of arterial access, coronary angiography and coronary intervention duration)
timeFrame: Procedural duration will be assessed within 1 minute after the end of coronary angiography or coronary intervention
Other outcomes:
Locations:
city: Patras
country: Greece
facility: Patras University Hospital
state: Rion
Study officials:
References:
citation: 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.