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

Sponsor:	NMT Medical
Information provided by:	NMT Medical
ClinicalTrials.gov Identifier:	NCT00283738

Purpose

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
Migraine Aura Patent Foramen Ovale	Device: BioSTAR Septal Repair Implant System Procedure: Sham Procedure	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine

U.S. FDA Resources

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

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

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Study ID Numbers:	G050119, MIST II
Study First Received:	January 27, 2006
Last Updated:	January 23, 2008
ClinicalTrials.gov Identifier:	NCT00283738 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by NMT Medical:

migraine
aura
Patent Foramen Ovale (PFO)

cardiac defects
Heart Septal Defects, Atrial
Cephalalgia

Additional relevant MeSH terms:

Heart Septal Defects
Heart Diseases
Cardiovascular Abnormalities
Nervous System Diseases
Central Nervous System Diseases
Headache Disorders, Primary
Brain Diseases

Heart Septal Defects, Atrial
Headache Disorders
Foramen Ovale, Patent
Migraine Disorders
Cardiovascular Diseases
Congenital Abnormalities
Heart Defects, Congenital

ClinicalTrials.gov processed this record on February 08, 2010