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

Migraine Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00283738
• Other study ID #: G050119
• Secondary ID: MIST II
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: January 27, 2006
• Last updated: January 23, 2008
• Start date: February 2006
• Est. completion date: March 2008

Study information

• Verified date: January 2008
• Source: NMT Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 610
• Est. completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aura
• Foramen Ovale, Patent
• Migraine
• Migraine Disorders
• Patent Foramen Ovale

Intervention

Device:
• BioSTAR Septal Repair Implant System
PFO Closure

Procedure:
• Sham Procedure
Catheterization

Locations

Country	Name	City	State
United States	Swedish Medical Center	Seattle	Washington
United States	New England Center for Headache	Stamford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
NMT Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: Migraine reduction rates during analysis period.
Primary	Safety: Incidence of Major Adverse Cardiac Events (MACE) one year post-implantation.
Secondary	Efficacy:Change in number of attacks from baseline period compared to analysis phase.
Secondary	Safety: Device success during index procedure without procedural complication.
Secondary	Incidence of major AEs during index procedure and post-procedure as they relate to the device and protocol specified medications.