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The Coherex FlatStent™ EF PFO Migraine Registry

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ClinicalTrials.gov Identifier: NCT01280578
Recruitment Status : Terminated (Lack of enrollment)
First Posted : January 21, 2011
Last Update Posted : June 27, 2017
Sponsor:
Information provided by (Responsible Party):
Coherex Medical

Brief Summary:
A prospective, single arm, multicenter clinical registry evaluating the change in migraine headaches in migraine with aura patients who undergo patent foramen ovale (PFO) closure with the Coherex FlatStent™ EF PFO Closure System.

Condition or disease Intervention/treatment
Patients With Migraine and PFO Device: Transcatheter PFO Closure

Study Type : Observational
Actual Enrollment : 3 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Coherex PFO Migraine Registry
Actual Study Start Date : February 1, 2011
Actual Primary Completion Date : June 1, 2012
Actual Study Completion Date : June 1, 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine
U.S. FDA Resources


Intervention Details:
    Device: Transcatheter PFO Closure
    Transcatheter PFO Closure
    Other Name: Coherex FlatStent™ EF PFO Closure System


Primary Outcome Measures :
  1. Efficacy
    Percentage of subjects treated with the FlatStent EF who, achieve a clinically significant reduction in migraine or probable migraine headache days at follow-up.


Secondary Outcome Measures :
  1. Closure efficacy
    Degree of closure of PFO at follow-up



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
NA. Study terminated
Criteria

Major Inclusion Criteria:

Age 18-65 males and non pregnant females History of refractory migraine Documented PFO

Major Exclusion Criteria:

Known allergy to aspirin or nickel. Medication Overuse Headache Body mass index > 40. Recent Botulinum neurotoxin type A treatment Other known structural heart disease, coronary artery disease, atrial fibrillation PFO morphology not suitable for FlatStent EF Patients who have had a stroke within the past two months Post-traumatic headache. Patients with diagnosed hypercoagulable states that require chronic treatment with warfarin.


Responsible Party: Coherex Medical
ClinicalTrials.gov Identifier: NCT01280578     History of Changes
Other Study ID Numbers: RESPONDER
First Posted: January 21, 2011    Key Record Dates
Last Update Posted: June 27, 2017
Last Verified: June 2017

Keywords provided by Coherex Medical:
Migraine

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases