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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified January 2008 by NMT Medical.
Recruitment status was: Active, not recruiting

Sponsor:

Information provided by:

NMT Medical

ClinicalTrials.gov Identifier:

NCT00283738

First received: January 27, 2006

Last updated: January 23, 2008

Last verified: January 2008

History of Changes

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 2 Phase 3


Study Type:	Interventional
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.

Resource links provided by NLM:

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
Active Comparator: 1	Device: BioSTAR Septal Repair Implant System PFO Closure
Placebo Comparator: 2 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 (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

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 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


ClinicalTrials.gov Identifier:	NCT00283738 History of Changes
Other Study ID Numbers:	G050119 MIST II
Study First Received:	January 27, 2006
Last Updated:	January 23, 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

ClinicalTrials.gov processed this record on July 18, 2017

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