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.
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.
- Aspirin (stroke prevention) Drug
Intervention Desc: Antiplatelet agent; inhibits thromboxane A2
- Clopidogrel (Plavix®)Drug
Other Names: Plavix, Clodelib, Clovelen Intervention Desc: Antiplatelet agent
- Dipyridamole (Persantine®)Drug
Intervention Desc: Platelet aggregation inhibitor
- Warfarin (Coumadin®)Drug
Other Names: Coumadin Intervention Desc: Anticoagulant (Vitamin K antagonist)
- AMPLATZER PFO Occluder Device
Intervention Desc: patent foramen ovale closure device ARM 1: Kind: Experimental Label: 1 Description: AMPLATZER PFO Occluder ARM 2: Kind: Experimental Label: Device Description: AMPLATZER PFO Occluder
- Standard of Care - Medical Management Other
Intervention Desc: Medical management - aspirin alone, Coumadin alone, Clopidogrel alone, aspirin combined with dipyridamole ARM 1: Kind: Experimental Label: 2 Description: Medical Management ARM 2: Kind: Experimental Label: Standard or Care - Medical Management Description: Medical treatment with Aspirin alone, Coumadin alone, Clopidogrel alone, or Aspirin combined with dipyridamole.
- Allocation: Randomized
- Masking: Open Label
- Purpose: Prevention
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
Patients are randomly assigned to best medical therapy or PFO closure with the AMPLATZER PFO Occluder. Best medical therapy treatment options include aspirin alone, Coumadin alone, clopidogrel alone, or aspirin combined with dipyridamole.
|Type||Measure||Time Frame||Safety Issue|
|Primary||The primary endpoint is recurrence of non-fatal stroke, post-randomization mortality, or fatal ischemic stroke.|
|Secondary||The secondary endpoints are complete closure of the defect at the six-month follow-up, absence of recurrent symptomatic cryptogenic nonfatal stroke or cardiovascular death, and occurrence of TIA.|
|Primary||Recurrence of nonfatal stroke||Annually until approved||No|
|Secondary||Complete closure of the defect demonstrated by TEE and bubble study (device group).||6 months||No|