The Coherex FlatStent™ EF PFO Migraine Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

3 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-01

Study Completion Date

2012-06-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Patients With Migraine and PFO

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Transcatheter PFO Closure

Intervention Type DEVICE

Other Intervention Names

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Coherex FlatStent™ EF PFO Closure System

Eligibility Criteria

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Inclusion Criteria

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

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No