Transradial Versus Transulnar Artery Approach for Coronary Interventions

Phase 3

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

• Registration Number: NCT01364532
• Lead Sponsor: University of Patras

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-04
• Study Start: 2011-04
• Study First Submitted: 2011-05-27
• Study First Submitted QC: 2011-05-31
• Last Update Submitted: 2011-05-31
• Study First Posted: 2011-06-02
• Last Update Posted: 2011-06-02
• Primary Completion: 2011-09
• Study Completion: 2011-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 572

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transradial arterial access	Transradial arterial access	Transradial arterial access for coronary angiography, ad-hoc or elective PCI
Transulnar arterial access	Transulnar arterial access	Transulnar arterial access for coronary angiography, ad-hoc or elective PCI

Primary Outcome Measures

Name	Time	Method
Successful arterial access free from need for crossover and free from vascular or coronary ischemic complications (MACEs)within 60± days	The primary end point will be assessed within 60±5 days after randomization	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

Name	Time	Method
Fluoroscopy time	Fluoroscopy time will be assessed within 1 minute after the end of coronary angiography or coronary intervention	Fluoroscopy time (in seconds) assessed within 1 minute after the end of coronary angiography or coronary intervention
Amount of contrast medium	The amount of contrast medium will be assessed within 1 minute after the end of coronary angiography or coronary intervention	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	Vascular complication will be assessed 6 hours after the end of coronary angiography or intervention	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)	Procedural duration will be assessed within 1 minute after the end of coronary angiography or coronary intervention	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

Trial Locations

Locations (1)

Patras University Hospital; 🇬🇷 Patras, Rion, Greece