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

Status unconfirmed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Migraine, Aura, Patent Foramen Ovale

In brief

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.

Key facts

Study ID

NCT00283738

Run by

NMT Medical

People needed

610

Starts

2006-02-01

Expected to finish

2008-03-01

Last updated by the study team

2008-01-25

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• New England Center for Headache — Stamford, Connecticut, United States
• Swedish Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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