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The Coherex FlatStent™ EF PFO Migraine Registry

This study has been terminated.
(Lack of enrollment)
Information provided by (Responsible Party):
Coherex Medical Identifier:
First received: January 19, 2011
Last updated: June 26, 2017
Last verified: June 2017
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 Intervention
Patients With Migraine and PFO Device: Transcatheter PFO Closure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Coherex PFO Migraine Registry

Resource links provided by NLM:

Further study details as provided by Coherex Medical:

Primary Outcome Measures:
  • 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:
  • Closure efficacy
    Degree of closure of PFO at follow-up

Enrollment: 3
Actual Study Start Date: February 1, 2011
Study Completion Date: June 1, 2012
Primary Completion Date: June 1, 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Transcatheter PFO Closure
    Transcatheter PFO Closure
    Other Name: Coherex FlatStent™ EF PFO Closure System

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

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.

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No Contacts or Locations Provided
  More Information

Responsible Party: Coherex Medical Identifier: NCT01280578     History of Changes
Other Study ID Numbers: RESPONDER
Study First Received: January 19, 2011
Last Updated: June 26, 2017

Keywords provided by Coherex Medical:

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases processed this record on September 19, 2017