NCT00201461UnknownPhase 2
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- NMT Medical
- Enrollment
- 900
- Locations
- 1
- Primary Endpoint
- Two (2) year incidence of stroke or Hard TIA
Study Overview
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 mortality in patients with a PFO and to demonstrate superiority of the STARFlex® device compared to best medical therapy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
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.
Arms & Interventions
1
Active Comparator
Best medical therapy
Intervention: Best medical therapy (Drug)
2
Experimental
STARFlex arm
Intervention: STARFlex septal closure system (Device)
Outcomes
Primary Outcomes
Two (2) year incidence of stroke or Hard TIA
Time Frame: 2 years
All cause mortality for the first 30 days of follow up/discharge, whichever is longer
Time Frame: 30 days
Neurological mortality from 31 days of follow up (F/U) or longer
Time Frame: 31 days
Secondary Outcomes
- Incidence of primary endpoint as a total and broken down by event type/treatment group in: stroke/TIA patients (pts) and DW-MR+ pts with symptoms < 24 hours(< 24 hrs)
- Incidence of primary endpoint in BMT group(2 years)
- Per treatment group, incidence of relevant/notable adverse events (AEs)(2 years)
- Device group: (1) Incidence of primary endpoint in pts prescribed aspirin (325 versus 81 mg) daily, (2) Incidence of relevant/notable AEs(2 years)
Investigators
Study Sites (1)
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