Trials / Not Yet Recruiting
Not Yet RecruitingNCT07300358
Study on the Safety and Effectiveness of a Biodegradable Patent Foramen Ovale Occluder System
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
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 258 (estimated)
- Sponsor
- Shanghai Lingsi Medical Technology Co., Ltd. · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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).
Conditions
- Cardiovascular Diseases
- Cardiovascular Abnormality
- Heart Defects, Congenital
- Heart Septal Defects
- Heart Septal Defects, Atrial
- Foramen Ovale, Patent
- Stroke, Ischemic
- Stroke (CVA) or TIA
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Active Comparator | Percutaneously occlusion of PFO with Cardi-o-fix PFO occluder |
| DEVICE | Experimental | Transcatheter closure of a patent foramen ovale (PFO) with biodegradable PFO occluder |
Timeline
- Start date
- 2025-12-30
- Primary completion
- 2027-06-30
- Completion
- 2027-06-30
- First posted
- 2025-12-23
- Last updated
- 2025-12-23
Source: ClinicalTrials.gov record NCT07300358. Inclusion in this directory is not an endorsement.