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Patent Foramen Ovale Closure or Medical Therapy After Stroke - RESPECT Trial

NCT00465270 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 980

Last updated 2019-02-18

Study results available
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Summary

The purpose of this study is to investigate whether percutaneous Patent Foramen Ovale (PFO) closure, using the AMPLATZER PFO Occluder, is superior to current standard of care medical treatment in the prevention of recurrent embolic stroke.

Conditions

  • Cryptogenic Stroke

Interventions

OTHER

Standard of Care - Medical Management

Medical management - aspirin alone, Coumadin alone, Clopidogrel alone, aspirin combined with dipyridamole

DEVICE

AMPLATZER PFO Occluder

patent foramen ovale closure device

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Jeffrey Saver, MD · UCLA Stroke Center

  • John D Carroll, MD · University of Colorado, Denver

  • Richard Smalling, MD · University of Texas Houston Health Science Center

  • David Thaler, MD · Tufts Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2003-08-31
Primary Completion
2012-05-31
Completion
2016-05-31

Countries

  • United States
  • Canada

Study Locations

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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 NCT00465270 on ClinicalTrials.gov