MIST II PFO-Migraine Trial With BioSTAR® Bioabsorbable Septal Repair Implant
Recruitment status was: Active, not recruiting
|Migraine Aura Patent Foramen Ovale||Device: BioSTAR Septal Repair Implant System Procedure: Sham Procedure||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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.|
- Efficacy: Migraine reduction rates during analysis period.
- Safety: Incidence of Major Adverse Cardiac Events (MACE) one year post-implantation.
- Efficacy:Change in number of attacks from baseline period compared to analysis phase.
- Safety: Device success during index procedure without procedural complication.
- Incidence of major AEs during index procedure and post-procedure as they relate to the device and protocol specified medications.
|Study Start Date:||February 2006|
|Estimated Study Completion Date:||March 2008|
|Active Comparator: 1||
Device: BioSTAR Septal Repair Implant System
Placebo Comparator: 2
Procedure: Sham Procedure
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00283738
|United States, Connecticut|
|New England Center for Headache|
|Stamford, Connecticut, United States, 06902|
|United States, Washington|
|Swedish Medical Center|
|Seattle, Washington, United States, 98104|
|Principal Investigator:||Mark Reisman, MD||Swedish Medical Center, Seattle, WA|
|Principal Investigator:||Stewart J. Tepper, MD||Director of the New England Center for Headache|