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

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ClinicalTrials.gov Identifier: NCT00283738
Recruitment Status : Unknown
Verified January 2008 by NMT Medical.
Recruitment status was:  Active, not recruiting
First Posted : January 30, 2006
Last Update Posted : January 25, 2008
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Migraine Aura Patent Foramen Ovale Device: BioSTAR Septal Repair Implant System Procedure: Sham Procedure Phase 2 Phase 3

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 610 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (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.
Study Start Date : February 2006
Estimated Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1 Device: BioSTAR Septal Repair Implant System
PFO Closure
Placebo Comparator: 2
Sham control
Procedure: Sham Procedure
Catheterization


Outcome Measures

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

Secondary Outcome Measures :
  1. Efficacy:Change in number of attacks from baseline period compared to analysis phase.
  2. Safety: Device success during index procedure without procedural complication.
  3. Incidence of major AEs during index procedure and post-procedure as they relate to the device and protocol specified medications.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00283738


Locations
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
Investigators
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

ClinicalTrials.gov Identifier: NCT00283738     History of Changes
Other Study ID Numbers: G050119
MIST II
First Posted: January 30, 2006    Key Record Dates
Last Update Posted: January 25, 2008
Last Verified: January 2008

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

Additional relevant MeSH terms:
Migraine Disorders
Foramen Ovale, Patent
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Heart Septal Defects, Atrial
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities