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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

NCT01014273 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 7021

Last updated 2011-04-07

No results posted yet for this study

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

PROCEDURE

Percutaneous Coronary Intervention

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Population Health Research Institute

    lead OTHER

Principal Investigators

  • Sanjit Jolly, MD, MSc, FRCPC · Population Health Research Institute

  • Susan Chrolavicius · Population Health Research Institute

  • Shamir Mehta, MD, MSc, FRCP(C), FACC · Population Health Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2011-02-28
Completion
2011-03-31

Countries

  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01014273 on ClinicalTrials.gov