NCT01014273

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

An International Randomized Trial of Trans-radial Versus Trans-femoral PCI Access Site Approach in Patients With Unstable Angina or Myocardial Infarction Managed With an Invasive Strategy. An Extension to the CURRENT (OASIS 7) Substudy (EFC5695): Effect of Type of Access for PCI (Radial or Femoral) on Bleeding Rate-Substudy.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 7,021 (actual)
• Sponsor: Population Health Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Coronary Syndrome
• Percutaneous Coronary Intervention

Interventions

Type	Name	Description
PROCEDURE	Percutaneous Coronary Intervention

Timeline

• Start date: 2006-06-01
• Primary completion: 2011-02-01
• Completion: 2011-03-01
• First posted: 2009-11-16
• Last updated: 2011-04-07

Locations

1 site across 1 country: Canada