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Clinical trial

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

NCT07300358 is registered in ClinicalTrials.gov with Shanghai Lingsi Medical Technology Co., Ltd. as lead sponsor.

NCT NCT07300358
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Registry record

As filed in ClinicalTrials.gov.

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
Lead sponsor
Shanghai Lingsi Medical Technology Co., Ltd.
Phase
Not applicable
Overall status
Not yet recruiting
Start date
December 30, 2025
Completion date
June 30, 2027
Enrollment
258 (estimated)
Sites
Not reported

Conditions

As the registry lists them; a condition with its own page is linked.

cardiovascular abnormality, cardiovascular diseases, foramen ovale, patent, heart defects, congenital, heart septal defects, heart septal defects, atrial, stroke (cva) or tia, stroke, ischemic