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)

NMT Medical

Status and phase

Unknown

Phase 3

Phase 2

Conditions

Ischemic Attack, Transient

Stroke

Patent Foramen Ovale

Treatments

Drug: Best medical therapy

Device: STARFlex septal closure system

Study type

Interventional

Funder types

Industry

Identifiers

NCT00201461

CLOSURE I

G980031

Details and patient eligibility

About

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.

Enrollment

900 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Major Inclusion Criteria:

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 Criteria:

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.