NCT01280578

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2011

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 21, 2011

Completed
11 days until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

June 27, 2017

Status Verified

June 1, 2017

Enrollment Period

1.3 years

First QC Date

January 19, 2011

Last Update Submit

June 26, 2017

Conditions

Patients With Migraine and PFO

Keywords

Migraine

Outcome Measures

Primary Outcomes (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 Outcomes (1)

  • Closure efficacy

Interventions

Transcatheter PFO ClosureDEVICE

Transcatheter PFO Closure

Also known as: Coherex FlatStent™ EF PFO Closure System

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

NA. Study terminated

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2011

First Posted

January 21, 2011

Study Start

February 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

June 27, 2017

Record last verified: 2017-06