At a glance
ClinicalIndex Comparison RecordN/ACompleted· 980 enrolled
Drug / intervention
AMPLATZER PFO Occluder +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment (RESPECT)
In Brief
A clinical study evaluating AMPLATZER PFO Occluder and Standard of Care - Medical Management for Cryptogenic Stroke. Completed, enrolled 980 participants across 69 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCryptogenic Stroke
CountriesCanada, United States
Collaborators--
Timeline
N/ACompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2003
First PostedApr 2007
Primary CompletionMay 2012
Study CompletionMay 2016
TodayJul 2026
First PostedApr 24, 2007
Enrollment StartAug 1, 2003
Primary CompletionMay 1, 2012
Study CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 8.8 yearsPosted 19.2 years ago
Interventions
AMPLATZER PFO Occluderdevice
patent foramen ovale closure device
Standard of Care - Medical Managementother
Medical management - aspirin alone, Coumadin alone, Clopidogrel alone, aspirin combined with dipyridamole