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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

610 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2008-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Migraine Aura Patent Foramen Ovale

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Group Type ACTIVE_COMPARATOR

BioSTAR Septal Repair Implant System

Intervention Type DEVICE

PFO Closure

2

Sham control

Group Type PLACEBO_COMPARATOR

Sham Procedure

Intervention Type PROCEDURE

Catheterization

Interventions

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BioSTAR Septal Repair Implant System

PFO Closure

Intervention Type DEVICE

Sham Procedure

Catheterization

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No