Patients With Migraine and PFONCT01280578
The Coherex FlatStent™ EF PFO Migraine Registry
An observational study of Patients With Migraine and PFO, run by Coherex Medical.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Patients With Migraine and PFO
- What is being tested?
- Transcatheter PFO Closure
- Type of treatment
- Medical device
- How many people
- 3 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2011to 1 Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: NA. Study terminated
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.
About this study
Official title: 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.
- Conditions
- Patients With Migraine and PFO
- Being tested
- Transcatheter PFO Closure
- Keywords
- Migraine
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter PFO ClosureDevice
Also called Coherex FlatStent™ EF PFO Closure System
Transcatheter PFO Closure
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (1)
Closure efficacy
Degree of closure of PFO at follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2011 (estimated)
- Study start1 Feb 2011
- Primary completion1 Jun 2012
- Study completion1 Jun 2012
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Migraine and PFOStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coherex Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01280578
- Sponsor's protocol ID
- RESPONDER
- Status last verified
- Jun 2017
- First submitted
- 19 Jan 2011
- Last updated
- 27 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Coherex PFO Migraine Registry
- ClinicalTrials.gov ID
- NCT01280578
- Acronym / sponsor ID
- RESPONDER
- Conditions
- Patients With Migraine and PFO
- Keywords
- Migraine
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Coherex MedicalIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2011 (actual)
- Primary completion
- 1 Jun 2012 (actual)
- Study completion
- 1 Jun 2012 (actual)
- First posted
- 21 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- NA. Study terminated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcatheter PFO ClosureAlso: Coherex FlatStent™ EF PFO Closure SystemTranscatheter PFO Closure | Device | – |
Primary outcome
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.
1 secondary outcome
Closure efficacy
Results and safety
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2017.
Related trials for Patients With Migraine and PFO
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Effects of PFO Closure on Glymphatic Function and Clinical Symptoms in Patients With Migraine
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Not yet recruitingObservational study
Multimodal Brain Function in Migraine Patients With Patent Foramen Ovale
PFO, Cognitive
Recruiting
A Comparison of Biodegradable and Metal Occluders in Patients With PFO and Migraine
PFO - Patent Foramen Ovale, Migraine
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients With Migraine and PFO, run by Coherex Medical.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2017.