Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 10:21 PM
Study NCT ID:
NCT07300358
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-23
First Post:
2025-09-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study on the Safety and Effectiveness of a Biodegradable Patent Foramen Ovale Occluder System
Sponsor:
Shanghai Lingsi Medical Technology Co., Ltd.
Organization:
Study Overview
Official Title:
BIOCLOSE-PFO Study：Evaluation of the Safety and Efficacy of a Biodegradable Patent Foramen Ovale Occluder System: A Prospective, Multicenter, Randomized Controlled, Non-Inferiority Clinical Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BIOCLOSE-PFO
Brief Summary:
To evaluate the Safety and Efficacy of a Novel Biodegradable Occluder for Percutaneous Closure of Patent Foramen Ovale (PFO)
Detailed Description:
This is a prospective, multicenter, randomized, controlled, non-inferiority clinical study. The study aims to evaluate the safety and efficacy of a novel biodegradable patent foramen ovale (PFO) occluder system compared to a conventional metallic occluder in patients with a PFO that is clinically determined to be associated with an PFO⁃associated stroke（PFO-AS）or transient ischemic attack (TIA).
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: