Trials / Unknown
UnknownNCT04973540
A Clinical Trial to Evaluate the Safety and Efficacy of IBS Angel in Patients With Pulmonary Artery Stenosis
A Prospective, Multi-center, Single-arm Clinical Trial to Evaluate the Safety and Efficacy of Iron Bioresorbable Scaffold System (IBS Angel) in Patients With Pulmonary Artery Stenosis
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 82 (estimated)
- Sponsor
- Biotyx Medical (Shenzhen) Co., Ltd. · Industry
- Sex
- All
- Age
- 1 Year – 14 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective, multi-center, single-arm clinical trial to evaluate the safety and efficacy of Iron Bioresorbable Scaffold System (IBS Angel) in patients with pulmonary artery stenosis.
Detailed description
82 patients with pulmonary artery stenosis will be treated with the Iron Bioresorbable Scaffold System (IBS Angel) developed by Biotyx Medical (Shenzhen) Co., Ltd. This study is designed as a prospective, multi-center, single-arm clinical trial. Enrolled patients will undergo IBS Angel implantation and will be followed up at 1, 3, 6, 12, and 24 months post-procedure.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Iron Bioresorbable Scaffold System (IBS Angel) | Subjects in this arm will be implanted with IBS Angel. |
Timeline
- Start date
- 2021-07-13
- Primary completion
- 2024-07-01
- Completion
- 2025-12-01
- First posted
- 2021-07-22
- Last updated
- 2021-11-19
Locations
10 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04973540. Inclusion in this directory is not an endorsement.