A Trial of Trans-radial Versus Trans-femoral Percutaneous Coronary Intervention (PCI) Access Site Approach in Patients With Unstable Angina or Myocardial Infarction Managed With an Invasive Strategy

Phase 3

Completed

• Conditions: Acute Coronary Syndrome; Percutaneous Coronary Intervention
• Interventions: Procedure: Percutaneous Coronary Intervention

• Registration Number: NCT01014273
• Lead Sponsor: Population Health Research Institute

Brief Summary

This is a multi-national, multi-centre, randomized study comparing the trans-radial PCI access strategy and the trans-femoral PCI access strategy in ACS patients with UA or NSTEMI or STEMI planned to be treated with an invasive strategy (PCI).

The hypothesis is that radial access site PCI will be associated with significantly less major bleeding and access site complications compared with a femoral approach, without increasing the risk of ischemic events. The overall benefit-risk profile will favor a trans-radial approach.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2009-11-13
• Study First Submitted QC: 2009-11-13
• Study First Posted: 2009-11-16
• Status Verified: 2011-02
• Primary Completion: 2011-02
• Study Completion: 2011-03
• Last Update Submitted: 2011-04-06
• Last Update Posted: 2011-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7021

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trans-femoral access	Percutaneous Coronary Intervention	Femoral artery PCI access site
Trans-radial access	Percutaneous Coronary Intervention	Radial artery PCI access site

Primary Outcome Measures

Name	Time	Method
First occurrence of the composite of death, MI, stroke or non CABG major bleeding (i.e. severe bleeding, other major bleeding) at 30 days.	30 days

Secondary Outcome Measures

Name	Time	Method
Death, MI or stroke	within 30 days following randomization
Non CABG major bleeding	within 30 days following randomization

Trial Locations

Locations (1)

Hamilton Health Sciences; 🇨🇦 Hamilton, Ontario, Canada