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The Coherex FlatStent™ EF PFO Migraine Registry

This study has been terminated.
(Lack of enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01280578
First Posted: January 21, 2011
Last Update Posted: June 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Coherex Medical
  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
Patients With Migraine and PFO Device: Transcatheter PFO Closure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Coherex PFO Migraine Registry

Resource links provided by NLM:


Further study details as provided by Coherex Medical:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Closure efficacy
    Degree of closure of PFO at follow-up


Enrollment: 3
Actual Study Start Date: February 1, 2011
Study Completion Date: June 1, 2012
Primary Completion Date: June 1, 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Transcatheter PFO Closure
    Transcatheter PFO Closure
    Other Name: Coherex FlatStent™ EF PFO Closure System
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
NA. Study terminated
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

Responsible Party: Coherex Medical
ClinicalTrials.gov Identifier: NCT01280578     History of Changes
Other Study ID Numbers: RESPONDER
First Submitted: January 19, 2011
First Posted: January 21, 2011
Last Update Posted: June 27, 2017
Last Verified: June 2017

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