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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
  Purpose

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.


Condition Intervention Phase
Patients With Migraine and PFO
 Device: Transcatheter PFO Closure
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Coherex PFO Migraine Registry

Resource links provided by NLM:

MedlinePlus related topics: Headache Migraine
U.S. FDA Resources

Further study details as provided by Coherex Medical:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Closure efficacy [ Designated as safety issue: No ]
    Degree of closure of PFO at follow-up


Estimated Enrollment: 200
Study Start Date: February 2011
Intervention Details:
    Device: Transcatheter PFO Closure
    Transcatheter PFO Closure
    Other Name: Coherex FlatStent™ EF PFO Closure System
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Clifford Montagnoli VP of Clinical Affairs, Coherex Medical
ClinicalTrials.gov Identifier: NCT01280578     History of Changes
Other Study ID Numbers: RESPONDER
Study First Received: January 19, 2011
Last Updated: January 19, 2011
Health Authority: Belgium: Ethics Committee

Keywords provided by Coherex Medical:
Migraine

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on June 18, 2013