Clinical trial NCT00283738: MIST II PFO-Migraine Trial With BioSTAR® Bioabsorbable Septal Repair Implant
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Migraine
Aura
Patent Foramen Ovale
Keywords: migraine
aura
Patent Foramen Ovale (PFO)
cardiac defects
Heart Septal Defects, Atrial
Cephalalgia
Lead sponsor: NMT Medical
Sponsor class: INDUSTRY
First posted: 2006-01-30
Enrollment: 610
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 aura) and who have failed medications.

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 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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Efficacy: Migraine reduction rates during analysis period.
measure: Safety: Incidence of Major Adverse Cardiac Events (MACE) one year post-implantation.
Secondary outcomes:
measure: Efficacy:Change in number of attacks from baseline period compared to analysis phase.
measure: Safety: Device success during index procedure without procedural complication.
measure: Incidence of major AEs during index procedure and post-procedure as they relate to the device and protocol specified medications.
Other outcomes:
Locations:
city: Stamford
country: United States
facility: New England Center for Headache
state: Connecticut
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
Study officials:
affiliation: Swedish Medical Center, Seattle, WA
name: Mark Reisman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Director of the New England Center for Headache
name: Stewart J. Tepper, MD
role: PRINCIPAL_INVESTIGATOR
References: