The Coherex FlatStent™ EF PFO Migraine Registry

The Coherex PFO Migraine Registry

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01280578

Enrollment

Registered

2011-01-21

Start date

2011-02-01

Completion date

2012-06-01

Last updated

2017-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients With Migraine and PFO

Keywords

Migraine

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.

Interventions

DEVICETranscatheter PFO Closure

Transcatheter PFO Closure

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion 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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Closure efficacy	—	Degree of closure of PFO at follow-up

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026