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The Coherex FlatStent™ EF PFO Migraine Registry

This study has been terminated.
(Lack of enrollment)
Sponsor:
Information provided by (Responsible Party):
Coherex Medical
ClinicalTrials.gov Identifier:
NCT01280578
First received: January 19, 2011
Last updated: June 26, 2017
Last verified: June 2017
January 19, 2011
June 26, 2017
February 1, 2011
June 1, 2012   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01280578 on ClinicalTrials.gov Archive Site
Closure efficacy
Degree of closure of PFO at follow-up
Same as current
Not Provided
Not Provided
 
The Coherex FlatStent™ EF PFO Migraine Registry
The Coherex PFO Migraine Registry
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
NA. Study terminated
Patients With Migraine and PFO
Device: Transcatheter PFO Closure
Transcatheter PFO Closure
Other Name: Coherex FlatStent™ EF PFO Closure System
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
3
June 1, 2012
June 1, 2012   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01280578
RESPONDER
Yes
Not Provided
Not Provided
Coherex Medical
Coherex Medical
Not Provided
Not Provided
Coherex Medical
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP