The Coherex FlatStent™ EF PFO Migraine Registry

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2011 by Coherex Medical.
Recruitment status was Not yet recruiting

Sponsor:

Information provided by:

Coherex Medical

ClinicalTrials.gov Identifier:

NCT01280578

First received: January 19, 2011

Last updated: NA

Last verified: January 2011

History: No changes posted

Tracking Information
First Received Date ^ICMJE	January 19, 2011
Last Updated Date	January 19, 2011
Start Date ^ICMJE	February 2011
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: January 19, 2011)	Efficacy [ Designated as safety issue: No ] Percentage of subjects treated with the FlatStent EF who, achieve a clinically significant reduction in migraine or probable migraine headache days at follow-up.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: January 19, 2011)	Closure efficacy [ Designated as safety issue: No ] Degree of closure of PFO at follow-up
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	The Coherex FlatStent™ EF PFO Migraine Registry
Official Title ^ICMJE	The Coherex PFO Migraine Registry
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Patients With Migraine and PFO
Intervention ^ICMJE	Device: Transcatheter PFO Closure Transcatheter PFO Closure Other Name: Coherex FlatStent™ EF PFO Closure System
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Not yet recruiting
Estimated Enrollment ^ICMJE	200
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01280578
Other Study ID Numbers ^ICMJE	RESPONDER
Has Data Monitoring Committee	Yes
Responsible Party	Clifford Montagnoli VP of Clinical Affairs, Coherex Medical
Study Sponsor ^ICMJE	Coherex Medical
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Coherex Medical
Verification Date	January 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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