NCT00465270

Patent Foramen Ovale Closure or Medical Therapy After Stroke - RESPECT Trial

Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment (RESPECT)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 980 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cryptogenic Stroke

Interventions

Type	Name	Description
DEVICE	AMPLATZER PFO Occluder	patent foramen ovale closure device
OTHER	Standard of Care - Medical Management	Medical management - aspirin alone, Coumadin alone, Clopidogrel alone, aspirin combined with dipyridamole

Timeline

• Start date: 2003-08-01
• Primary completion: 2012-05-01
• Completion: 2016-05-01
• First posted: 2007-04-24
• Last updated: 2019-02-18
• Results posted: 2018-09-04

Locations

69 sites across 2 countries: United States, Canada