NCT01364532

Transradial Versus Transulnar Artery Approach for Coronary Interventions

A Randomized Study of Transradial Versus Transulnar Artery Approach for Coronary Interventions

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 572 (estimated)
• Sponsor: University of Patras · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Arterial Access in Percutaneous Coronary Angiography or Intervention

Interventions

Type	Name	Description
PROCEDURE	Transulnar arterial access	Transulnar arterial access in coronary angiography, ad-hoc or elective PCI
PROCEDURE	Transradial arterial access	Transradial arterial access for coronary angiography,ad-hoc or elective PCI

Timeline

• Start date: 2011-04-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2011-06-02
• Last updated: 2011-06-02

Locations

1 site across 1 country: Greece