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

January 23, 2008 updated by: NMT Medical

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

610

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Stamford, Connecticut, United States, 06902
        • New England Center for Headache
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NMT Medical

Investigators

  • Principal Investigator: Stewart J. Tepper, MD, Director of the New England Center for Headache

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Study Completion (Anticipated)

March 1, 2008

Study Registration Dates

First Submitted

January 27, 2006

First Submitted That Met QC Criteria

January 27, 2006

First Posted (Estimate)

January 30, 2006

Study Record Updates

Last Update Posted (Estimate)

January 25, 2008

Last Update Submitted That Met QC Criteria

January 23, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G050119
  • MIST II

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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