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

NMT Medical610 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

610

Conditions

Migraine Aura Patent Foramen Ovale

Interventions

BioSTAR Septal Repair Implant SystemDEVICE

PFO Closure

Sham ProcedurePROCEDURE

Catheterization

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (2)

New England Center for Headache

Stamford, Connecticut, United States

Swedish Medical Center

Seattle, Washington, United States

Outcomes

Primary Outcomes

Efficacy: Migraine reduction rates during analysis period.

Safety: Incidence of Major Adverse Cardiac Events (MACE) one year post-implantation.

Secondary Outcomes

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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.