Migraine Clinical Trial
Official title:
A Prospective, Multi-Center, Double-Blinded, Placebo-Controlled Trial to Evaluate the Effectiveness of Patent Foramen Ovale Closure With the BioSTAR Septal Repair Implant to Reduce Refractory Migraine Headache With Aura.
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 aura) and who have failed medications.
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 single and multi-center experiences of over 400 patients, suggest Patent
Foramen Ovale (PFO) closure to reduce the risk of recurrent migraine events in these
populations may be beneficial, particularly for those patients in the migraine with aura
subgroup. Although none of these reports are from prospective, randomized, controlled
trials, the reports are compelling enough in their totality to support further investigation
of a well defined group in a prospective manner. The patients reported in these studies were
brought to PFO closure with no expectation of their procedure having any impact on their
migraine. In fact, in many cases, the discovery of a history of migraine was not made until
well after the PFO closure procedure.
This clinical trial will prospectively compare the safety and effectiveness of PFO closure
with the BioSTAR device to a control arm. Patients will be followed one year post-implant.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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