Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00283738
Status:
UNKNOWN
Last Update Posted:
2008-01-25
First Post:
2006-01-27
Brief Title:
MIST II PFO-Migraine Trial With BioSTAR Bioabsorbable Septal Repair Implant
Sponsor:
NMT Medical
Organization:
NMT Medical
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2008-01
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MIST II | None | None | None |