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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
Est. primary completion date
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


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.
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