Overview

Evaluation of the STARFlex® Septal Closure System in Patients With a Stroke or TIA Due to the Possible Passage of a Clot of Unknown Origin Through a Patent Foramen Ovale (PFO)

Status:
Unknown status

Trial end date:
2010-04-01

Target enrollment:

Participant gender:

Summary

The primary objective of the study is to determine whether the STARFlex® septal closure system will safely and effectively prevent a recurrent embolic stroke/transient ischemic attack (TIA) and mortality in patients with a PFO and to demonstrate superiority of the STARFlex® device compared to best medical therapy.

Phase:

Phase 2/Phase 3

Details

Lead Sponsor:

NMT Medical

Treatments:

Acetaminophen