Patients With Migraine and PFO Clinical Trial
Official title:
The Coherex PFO Migraine Registry
| Verified date | June 2017 |
| Source | Coherex Medical |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Terminated |
| Enrollment | 3 |
| Est. completion date | June 1, 2012 |
| Est. primary completion date | June 1, 2012 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Coherex Medical |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Closure efficacy | Degree of closure of PFO at follow-up |