Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-31 @ 2:12 AM
Study NCT ID:
NCT04029233
Status:
TERMINATED
Last Update Posted:
2024-09-19
First Post:
2019-07-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The PROOF Trial - Prospective, Open-label, Multicenter, Non-randomized Investigation on Percutaneous Patent Foramen Ovale (PFO) Closure Using the Occlutech PFO Occluder to Prevent Recurrence of Stroke in Patients With Cryptogenic Stroke and High Risk PFO
Sponsor:
Occlutech International AB
Organization:
Study Overview
Official Title:
Prospective, Open-label, Multicenter, Non-randomized Investigation on Percutaneous Patent Foramen Ovale (PFO) Closure Using the Occlutech PFO Occluder to Prevent Recurrence of Stroke in Patients With Cryptogenic Stroke and High Risk PFO
Status:
TERMINATED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not due to safety concerns,high procedure success rate,6mo closure rate 94.2%,rate of SADE1.1%, 12mo rcurrent stroke rate 0.8%.Concurrent OCCLUFLEX trial+projected completion earlier than PROOF FU,no need to demonstrate add.level of efficacy evidence
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROOF
Brief Summary:
Percutaneous transcatheter closure of a patent foramen ovale (PFO) to reduce the risk of recurrent ischemic stroke in patients who have had a cryptogenic stroke due to a presumed paradoxical embolism.
Detailed Description:
This study aims to investigate stroke recurrence rates after interventional PFO closure with an Occlutech PFO Occluder in patients who have experienced at least one ischemic cryptogenic stroke attributed to patent foramen ovale (PFO) who have high risk PFO, i.e. large PFO (≥2 mm), or PFO of any size and atrial septal aneurysm (ASA).
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: