Status:
UNKNOWN
MIST II PFO-Migraine Trial With BioSTAR® Bioabsorbable Septal Repair Implant
Lead Sponsor:
NMT Medical
Conditions:
Migraine
Aura
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
PHASE3
Brief Summary
The objective of the study is to investigate the safety and effectiveness of PFO closure with the BioSTAR Septal Repair Implant System in a population of patients that have refractory migraine (with a...
Detailed Description
During the last five years, transcatheter and surgical closure of PFO in the cyrptogenic stroke and TIA population has grown in frequency world-wide. Observational retrospective reports, from both sin...
Eligibility Criteria
Inclusion
- age between 18 and 60.
- migraine history prior to age 50
- must meet definition of refractory migraine with aura
- must have a Patent Foramen Ovale (PFO) within bubble study specifications.
- must provide informed consent. Guardian consent is not accepted.
- patient's heart structure and vasculature must be compatible with BioSTAR Septal Repair Implant System.
- patient must not be pregnant and agrees not to become pregnant during study participation
Exclusion
- Medical conditions or medications that are not compatible with protocol or that would increase the patient's risk.
- patient must not have any cardiac or vascular anomalies, repaired or not, that would be incompatible with the delivery system or device for PFO occlusion.
- Currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current trial endpoints.
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2008
Estimated Enrollment :
610 Patients enrolled
Trial Details
Trial ID
NCT00283738
Start Date
February 1 2006
End Date
March 1 2008
Last Update
January 25 2008
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
New England Center for Headache
Stamford, Connecticut, United States, 06902
2
Swedish Medical Center
Seattle, Washington, United States, 98104