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 (RIVAL)

April 6, 2011 updated by: Population Health Research Institute

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7021

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Hamilton Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

INCLUSION CRITERIA

1.1 UA/NSTEMI patients

Ischemic symptoms suspected to represent a non-ST segment elevation ACS (unstable angina [UA] or non-ST segment elevation myocardial infarction NSTEMI) defined as:

Clinical history consistent with new onset, or a worsening pattern, of characteristic ischemic chest pain occurring at rest or with minimal exercise (lasting longer than 10 minutes) and planned to be managed with an invasive strategy

AND at least one of the following:

  1. Electrocardiogram (ECG) changes compatible with new ischemia [ST depression of at least 1mm or transient ST elevation or ST elevation of less than or equal to 1 mm or T wave inversion greater than 2 mm in at least 2 contiguous leads].

    or

  2. Patients > 60 years of age with normal ECG are eligible provided there is a high degree of certainty that presenting symptoms are due to myocardial ischemia. Such patients must have documented evidence of previous coronary artery disease (CAD) with at least one of the following:

    • Prior MI requiring hospitalization
    • Prior revascularization procedure (more than 3 months ago)
    • Cardiac catheterization showing significant CAD
    • Positive exercise test
    • Other objective evidence of atherosclerotic vascular disease or
  3. Already elevated cardiac enzymes or troponin I or T above the upper limit of normal.

1.2 STEMI patients

  1. Presenting with signs or symptoms of acute myocardial infarction lasting at least 20 minutes and planned to be managed with an invasive strategy with intent to perform a percutaneous coronary intervention (PCI) during the index hospitalization.

  2. Definite ECG changes compatible with STEMI: persistent ST-elevation (> 2 mm in two contiguous precordial leads or > 1 mm in at least two limb leads), or new left bundle branch block, or Q-wave in 2 contiguous leads

    2) Randomized during index hospitalization for acute coronary syndrome 3) Suitable candidate for either radial or femoral artery PCI 4) Intent to perform same-sitting angiography and PCI. 5) Palpable radial artery with documented normal Allen's test 6) Acceptance by operator to use whichever route is assigned by the randomization process 7) Previous experience of the operator with at least 50 cases of radial artery access within the past year 8) Written informed consent

    EXCLUSION CRITERIA

    1. Age < 18 years
    2. Active bleeding or significant increased risk of bleeding, severe hepatic insufficiency, current peptic ulceration, proliferative diabetic retinopathy.
    3. Uncontrolled hypertension
    4. Cardiogenic shock
    5. Prior CABG surgery with use of more than one internal mammary artery
    6. Documented severe peripheral vascular disease precluding a femoral approach
    7. Participation in any study with an investigational drug or device within the previous 30 days
    8. Medical, geographic or social factors making study participation impractical

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Trans-femoral access
Femoral artery PCI access site
Procedure: Percutaneous Coronary Intervention
ACTIVE_COMPARATOR: Trans-radial access
Radial artery PCI access site
Procedure: Percutaneous Coronary Intervention

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Non CABG major bleeding
Time Frame: within 30 days following randomization
within 30 days following randomization
Death, MI or stroke
Time Frame: within 30 days following randomization
within 30 days following randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Population Health Research Institute

Collaborators

Sanofi

Investigators

  • Principal Investigator: Sanjit Jolly, MD, MSc, FRCPC, Population Health Research Institute
  • Study Director: Susan Chrolavicius, Population Health Research Institute
  • Principal Investigator: Shamir Mehta, MD, MSc, FRCP(C), FACC, Population Health Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (ACTUAL)

February 1, 2011

Study Completion (ACTUAL)

March 1, 2011

Study Registration Dates

First Submitted

November 13, 2009

First Submitted That Met QC Criteria

November 13, 2009

First Posted (ESTIMATE)

November 16, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

April 7, 2011

Last Update Submitted That Met QC Criteria

April 6, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rad-Fem PCI Access Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Coronary Syndrome

Clinical Trials on Percutaneous Coronary Intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovakia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe