Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment (RESPECT)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Abbott Medical Devices
- Enrollment
- 980
- Locations
- 69
- Primary Endpoint
- Composite of Recurrent Nonfatal Ischemic Stroke, Fatal Ischemic Stroke, or Early Death After Randomization
Study Overview
Brief Summary
The purpose of this study is to investigate whether percutaneous Patent Foramen Ovale (PFO) closure, using the AMPLATZER PFO Occluder, is superior to current standard of care medical treatment in the prevention of recurrent embolic stroke.
Detailed Description
The AMPLATZER PFO Occluder is a percutaneous, transcatheter occlusion device intended for the non-surgical closure of patent foramen ovale in subjects who have had a cryptogenic stroke due to presumed paradoxical embolism within the last 270 days.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects who have had a cryptogenic stroke within the last 270 days
- •Subjects who have been diagnosed with a Patent Foramen Ovale (PFO)
- •Subjects willing to participate in follow-up visits
Exclusion Criteria
- •Subjects with intracardiac thrombus or tumor
- •Subjects who have an acute or recent (within 6 months) myocardial infarction or unstable angina
- •Subjects with left ventricular aneurysm or akinesis
- •Subjects with atrial fibrillation/atrial flutter (chronic or intermittent)
- •Subjects with another source of right to left shunt identified at baseline, including an atrial septal defect and/or fenestrated septum
- •Subjects with contraindication to aspirin or Clopidogrel therapy
- •Pregnant or desire to become pregnant within the next year
Arms & Interventions
Device
AMPLATZER PFO Occluder
Intervention: AMPLATZER PFO Occluder (Device)
Standard or Care - Medical Management
Medical treatment with Aspirin alone, Coumadin alone, Clopidogrel alone, or Aspirin combined with dipyridamole.
Intervention: Standard of Care - Medical Management (Other)
Outcomes
Primary Outcomes
Composite of Recurrent Nonfatal Ischemic Stroke, Fatal Ischemic Stroke, or Early Death After Randomization
Time Frame: Trial enrollment was stopped once 25 unique subjects were mutually adjudicated by the CEC and DSMB as having experienced a primary endpoint event. This occurred on December 20, 2011. The mean follow-up time was 2.6 years.
Nonfatal stroke is defined as: focal neurological deficit presumed to be due to focal ischemia, and either 1) symptoms persisting 24 hours or greater, or 2) symptoms persisting less than 24 hours but associated with MR or CT imaging findings of a new, neuroanatomically relevent, cergral infarct. Post-randomization death is defined as: in the MM group as all-cause mortality within 45 days after randomization, and in the device group as all-cause mortality 30 days after implant or 45 days after randomizaiton, whichever occurs last.
Secondary Outcomes
- Rate of Complete PFO Closure (Assessed by TEE Bubble Study) at the 6-month Follow-up in the Device Group(6 months)