The Coherex FlatStent™ EF PFO Migraine Registry

Coherex Medical3 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Patients With Migraine and PFO

Interventions

Transcatheter PFO ClosureDEVICE

Transcatheter PFO Closure

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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 Outcomes

Closure efficacy

Degree of closure of PFO at follow-up

Data from ClinicalTrials.gov

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