NCT00201461

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)

A Prospective, Multicenter, Randomized Controlled Trial to Evaluate the Safety and Efficacy of the STARFlex® Septal Closure System Versus Best Medical Therapy in Patients With a Stroke and/or Transient Ischemic Attack Due to Presumed Paradoxical Embolism Through a Patent Foramen Ovale

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 900 (estimated)
• Sponsor: NMT Medical · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Patent Foramen Ovale
• Stroke
• Ischemic Attack, Transient

Interventions

Type	Name	Description
DEVICE	STARFlex septal closure system	transcatheter placement of STARFlex device to close a patent foramen ovale
DRUG	Best medical therapy	aspirin (325 mg daily) and/or warfarin (target INR = 2.5)

Timeline

• Start date: 2003-06-01
• Completion: 2010-04-01
• First posted: 2005-09-20
• Last updated: 2008-12-30

Locations

1 site across 1 country: United States