This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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
  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

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
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, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: Coherex Medical
ClinicalTrials.gov Identifier: NCT01280578     History of Changes
Other Study ID Numbers: RESPONDER
Study First Received: January 19, 2011
Last Updated: June 26, 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

ClinicalTrials.gov processed this record on July 26, 2017