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Interventional Management of Stroke (IMS) III Trial

NCT00359424 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 656

Last updated 2013-12-13

Study results available
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Summary

The purpose of this study is to compare two different treatment approaches to recanalization started within 3 hours of symptom onset-combined intravenous (IV) and endovascular therapy and standard intravenous (IV) rt-PA alone.

Conditions

Interventions

DRUG

IV rt-PA alone

Intravenous (IV) recombinant tissue plasminogen activator (rt-PA) is the only approved acute stroke therapy; Group one will receive the standard dose of IV rt-PA given over an hour.

OTHER

endovascular therapy

Group two will receive a lower dose or the standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery. Endovascular therapy can be implemented with or without interarterial rt-PA use.

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Medical University of South Carolina

    collaborator OTHER

  • University of Calgary

    collaborator OTHER

  • Joseph Broderick

    lead OTHER

Principal Investigators

  • Joseph P. Broderick, MD · Primary Neurologist Investigator, University of Cincinnati Academic Health Center

  • Thomas A. Tomsick, MD · Primary Interventional Investigator, University of Cincinnati Academic Health Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
82 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2012-07-31
Completion
2013-04-30

Countries

  • United States
  • Australia
  • Canada
  • France
  • Germany
  • Netherlands
  • Spain
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

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 NCT00359424 on ClinicalTrials.gov