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

January 19, 2011
January 19, 2011
February 2011
Not Provided
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.
Same as current
No Changes Posted
Closure efficacy [ Designated as safety issue: No ]
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
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.
 
Not yet recruiting
200
Not Provided
Not Provided

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.

Both
18 Years to 65 Years
No
Not Provided
Not Provided
 
NCT01280578
RESPONDER
Yes
Clifford Montagnoli VP of Clinical Affairs, Coherex Medical
Coherex Medical
Not Provided
Not Provided
Coherex Medical
January 2011

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