No phaseRecruiting
Comparing Two PFO Closure Devices in Adults With Previous Stroke or TIA (SAFE-PFO)
Randomised Controlled Trial Comparing the Safety and EfficAcy of the Cocoon PFO Occluder Versus Amplatzer PFO ClosurE Device for Percutaneous Closure of Patent Foramen Ovale in Patients With a History of Stroke or Transient Ischemic Attack A Non-Profit, Single-blind, Investigator Driven Trial
- Sponsor
- Giuseppe Tarantini (Industry)
- Enrollment
- 1,260 planned
- Conditions
- Patent Foramen Ovale; Stroke; Transient Ischemic Attack (TIA)
- Interventions
- PFO Closure procedure
- Ages
- adults, older adults
- Registry
- NCT07380490
Full record on ClinicalTrials.gov
From the registry
This study is a prospective, multicenter, randomized, controlled, single-blind, investigator-driven, non-profit clinical trial designed to compare the safety and efficacy of the Cocoon PFO Occluder with the Amplatzer PFO Occluder family in patients requiring percutaneous closure of a patent foramen ovale (PFO). Eligible participants are adults with a history of cryptogenic embolic stroke or neurologically confirmed transient ischemic attack (TIA) within the previous 12 months and a PFO suitable for transcatheter closure. A total of up to 1260 subjects will be enrolled across multiple European centers. Participants will be randomly assigned in a 3:1 ratio to receive either the Cocoon PFO Occluder (experimental group) or an Amplatzer PFO closure device (control group). The procedure will be performed as soon as possible after randomization, preferably within 14 days and no later than 45 days. The primary endpoint is a non-inferiority comparison of a composite outcome at 12 months, including recurrent ischemic stroke, TIA, or all-cause death. Secondary endpoints include PFO closure…
Primary outcomes
- Composite endpoint of recurrent ischemic stroke, TIA, or all-cause death at 12 months
History
Primary completion expected
Last registry update
Started
Registered