MedTrace Logo

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

NCT00283738 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 610

Last updated 2008-01-25

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

BioSTAR Septal Repair Implant System

PFO Closure

PROCEDURE

Sham Procedure

Catheterization

Sponsors & Collaborators

  • NMT Medical

    lead INDUSTRY

Principal Investigators

  • Mark Reisman, MD · Swedish Medical Center, Seattle, WA

  • Stewart J. Tepper, MD · Director of the New England Center for Headache

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Completion
2008-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00283738 on ClinicalTrials.gov