Clinical Trials and Research Display
Trial Information |
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| 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 Identifier | IRB # 00210 | | Sponsor | NMT Medical | | Physicians | | | Facility | - Caritas St. Elizabeth's Medical Center (Recruiting)
| | Global Trial Status | Recruiting | | Study Phase | Phase 2/Phase 3 |
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Trial Conditions |
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| Ischemic stroke with Patent Foramen Ovale |
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Other Trial Information |
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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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