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

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Mark Reisman, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: NMT Medical

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Stewart J. Tepper, MD

Principal Investigator

Director of the New England Center for Headache

Mark Reisman, MD

Principal Investigator

Swedish Medical Center, Seattle, WA

Eligibility Criteria

Inclusion Criteria

age between 18 and 60.

migraine history prior to age 50

must meet definition of refractory migraine with aura

Treatment Details

Interventions

• BioSTAR Septal Repair Implant System (Bioabsorbable Implant)

Participant Groups

Group I: 1 Active Control 1 Intervention

Group II: 2 Placebo Group 1 Intervention

Sham control

Who Is Running the Clinical Trial?

NMT Medical

Lead Sponsor

Trials

2

Recruited

1,500+