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Trial Information

Title (CLOSURE I) 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
Trial IdentifierIRB # 00210
SponsorNMT Medical
  • Judith Hinchey, MD, MS
  • Caritas St. Elizabeth's Medical Center  (Recruiting)
Global Trial StatusRecruiting
Study PhasePhase 2/Phase 3

Trial Conditions

Ischemic stroke with Patent Foramen Ovale

Contact Information


Ellie Rosseto
Caritas St. Elizabeth's Medical Center Phone: 617-789-2440 Email: ellie.rosseto@caritaschristi.org

Other Trial Information

Trial Rationale and Purpose

The purpose of this research study is to compare the STARFlex device to medication in preventing a recurrent stroke or TIA associated with a PFO.

Trial Inclusion/Exclusion Criteria


· Eligibility:

            Ages Eligible for Study: 18-60 years

            Genders Eligible for Study: Both

            Accepts Healthy Volunteers: No


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.

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