Status:
UNKNOWN
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)
Lead Sponsor:
NMT Medical
Conditions:
Patent Foramen Ovale
Stroke
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
PHASE3
Brief 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 mortal...
Eligibility Criteria
Inclusion
- Major
- Age 18-60 years inclusive.
- Positive contrast valsalva bubble study by trans-esophageal echocardiogram (TEE) for patent foramen ovale (PFO), with or without atrial septal aneurysm.
- Stroke or clinically definite TIA (contact study coordinator).
- Be able to comply with follow up over two years.
- Be competent to, or have a legal guardian competent to, provide informed consent following full disclosure of risks and benefits of both treatment arms by a study investigator.
- Venous access capable of accepting a 10F minimum vascular sheath.
- Have, or be willing to, discontinue hormonal based contraceptive use prior to enrollment and for the term of the study.
- Has cardiac anatomy based on enrollment echocardiogram that will allow for placement of the implant if randomized to the implant arm.
- Note: Additional inclusion criteria may apply. Contact study coordinator or principal investigator for details.
- Post-randomization - device patients only
- The size of the PFO (measured by indentation with a soft balloon) must be amenable to selection of a STARFlex device.
- Major
Exclusion
- Carotid artery stenosis \> 50%.
- Intracranial stenosis \> 50% appropriate to symptoms.
- Complex aortic arch atheroma with high risk features for embolism
- Aortic arch, carotid or vertebral artery dissection.
- Mitral or aortic valve stenosis, vegetation, or calcification \> 5 mm mitral annular calcification (MAC) thickness.
- Active pregnancy.
- Active infections (contact study coordinator).
- Active infective endocarditis or bacteremia.
- Prosthetic heart valves in any location.
- Anterior MI within 3 months of neurological event.
- Chronic atrial fibrillation
- Thrombus in, or occluded, venous access route.
- Contraindication to heparin, aspirin, clopidogrel, or warfarin, or a known medical condition that requires continuous warfarin.
- Patient enrolled in another investigation study where clinical endpoint interference may occur.
- Permanent pacemaker or inferior vena cava (IVC) filter.
- Serum creatinine \> 2.0 mg/dL
- Patients with known vasculitis or neurologic disorder.
- Baseline modified Rankin score of 3 or more.
- Hypercoagulopathies requiring long-term warfarin.
- Note: Additional exclusion criteria may apply.
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2010
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT00201461
Start Date
June 1 2003
End Date
April 1 2010
Last Update
December 30 2008
Active Locations (1)
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1
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195