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MIST II PFO-Migraine Trial With BioSTAR® Bioabsorbable Septal Repair Implant

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by NMT Medical.
Recruitment status was  Active, not recruiting
Information provided by:
NMT Medical Identifier:
First received: January 27, 2006
Last updated: January 23, 2008
Last verified: January 2008

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.

Condition Intervention Phase
Patent Foramen Ovale
Device: BioSTAR Septal Repair Implant System
Procedure: Sham Procedure
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:

Further study details as provided by NMT Medical:

Primary Outcome Measures:
  • Efficacy: Migraine reduction rates during analysis period.
  • Safety: Incidence of Major Adverse Cardiac Events (MACE) one year post-implantation.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 610
Study Start Date: February 2006
Estimated Study Completion Date: March 2008
Arms Assigned Interventions
Active Comparator: 1 Device: BioSTAR Septal Repair Implant System
PFO Closure
Placebo Comparator: 2
Sham control
Procedure: Sham Procedure

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.


Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its 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
Sponsors and Collaborators
NMT Medical
Principal Investigator: Mark Reisman, MD Swedish Medical Center, Seattle, WA
Principal Investigator: Stewart J. Tepper, MD Director of the New England Center for Headache
  More Information

No publications provided Identifier: NCT00283738     History of Changes
Other Study ID Numbers: G050119, MIST II
Study First Received: January 27, 2006
Last Updated: January 23, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by NMT Medical:
Patent Foramen Ovale (PFO)
cardiac defects
Heart Septal Defects, Atrial

Additional relevant MeSH terms:
Foramen Ovale, Patent
Migraine Disorders
Brain Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases
Central Nervous System Diseases
Congenital Abnormalities
Headache Disorders
Headache Disorders, Primary
Heart Defects, Congenital
Heart Diseases
Heart Septal Defects
Heart Septal Defects, Atrial
Nervous System Diseases processed this record on November 20, 2014