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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBS Angel | Experimental | Iron Bioresorbable Scaffold System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iron Bioresorbable Scaffold System (IBS Angel) | Device | Subjects in this arm will be implanted with IBS Angel. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of freedom from in-stent restenosis | Defined on a per target lesion basis. | 12 months |
| Rate of procedural success | Defined on a per target lesion basis. | Immediately post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of technical success | Defined on a per target lesion basis. | Immediately post-procedure |
| Rate of freedom from in-stent restenosis | Defined on a per target lesion basis. |
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Inclusion Criteria:
Patients must between 1 and 14 years old.
Patients who have congenital or secondary pulmonary artery stenosis (including pulmonary artery trunk, left pulmonary artery and right pulmonary artery), and meeting one of the following criteria:
A: The pressure gradient across the stenosis ≥20mmHg measured by catheter; B: The degree of pulmonary artery stenosis ≥50% ( calculated by (diameter of adjacent normal segments - residual lumen diameter of the stenosis segment)/diameter of adjacent normal segments ×100%); C: The ratio of right ventricular systolic pressure to aortic systolic pressure ≥50%.
Patients and whose family have high compliance, voluntarily participate in and sign the informed consent form, and complete the 2-year follow-up.
Patients have life expectancy >2 year after successful stent implantation.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ying Xia | Contact | 86 13760184511 | xiaying@lifetechmed.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Xiangya Hospital of Central South University | Not yet recruiting | Changsha | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35979021 | Derived | Sun L, Li JJ, Xu YK, Xie YM, Wang SS, Zhang ZW. Initial status and 3-month results relating to the use of biodegradable nitride iron stents in children and the evaluation of right ventricular function. Front Cardiovasc Med. 2022 Aug 1;9:914370. doi: 10.3389/fcvm.2022.914370. eCollection 2022. |
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| 1 month |
| Rate of freedom from in-stent restenosis | Defined on a per target lesion basis. | 3 months |
| Rate of freedom from in-stent restenosis | Defined on a per target lesion basis. | 6 months |
| Rate of device-related adverse events | 1 month |
| Rate of device-related serious adverse events | 1 month |
| Rate of device-related adverse events | 3 months |
| Rate of device-related serious adverse events | 3 months |
| Rate of device-related adverse events | 6 months |
| Rate of device-related serious adverse events | 6 months |
| Rate of device-related adverse events | 12 months |
| Rate of device-related serious adverse events | 12 months |
| Rate of device-related adverse events | 24 months |
| Rate of device-related serious adverse events | 24 months |
| Rate of unplanned surgery or re-intervention | 1 month |
| Rate of unplanned surgery or re-intervention | 3 months |
| Rate of unplanned surgery or re-intervention | 6 months |
| Rate of unplanned surgery or re-intervention | 12 months |
| Rate of unplanned surgery or re-intervention | 24 months |
| Rate of stent thrombosis | 1 month |
| Rate of stent thrombosis | 3 months |
| Rate of stent thrombosis | 6 months |
| Rate of stent thrombosis | 12 months |
| Rate of stent thrombosis | 24 months |
| Rate of all-cause death | 1 month |
| Rate of all-cause death | 3 months |
| Rate of all-cause death | 6 months |
| Rate of all-cause death | 12 months |
| Rate of all-cause death | 24 months |
| Rate of stent displacement | 1 month |
| Rate of stent displacement | 3 months |
| Rate of stent displacement | 6 months |
| Rate of stent displacement | 12 months |
| Rate of adverse events | 1 month |
| Rate of serious adverse events | 1 month |
| Rate of adverse events | 3 months |
| Rate of serious adverse events | 3 months |
| Rate of adverse events | 6 months |
| Rate of serious adverse events | 6 months |
| Rate of adverse events | 12 months |
| Rate of serious adverse events | 12 months |
| Rate of adverse events | 24 months |
| Rate of serious adverse events | 24 months |
| Rate of device deficiency | Day 0 |
| Children's Hospital of Chongqing Medical University | Not yet recruiting | Chongqing | China |
|
| The People's Hospital of Gaozhou | Recruiting | Gaozhou | China |
|
| Guangdong Provincial People's Hospital | Recruiting | Guangzhou | China |
|
| Fuwai Yunnan Cardiovascular Hospital | Not yet recruiting | Kunming | China |
|
| Shanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine | Not yet recruiting | Shanghai | China |
|
| Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Not yet recruiting | Shanghai | China |
|
| General Hospital of Northern Theater Command of Chinese People's Liberation Army | Not yet recruiting | Shenyang | China |
|
| Shenzhen Children's Hospital | Not yet recruiting | Shenzhen | China |
|
| Fuwai Central China Cardiovascular Hospital | Not yet recruiting | Zhengzhou | China |
|
| ID | Term |
|---|---|
| D000071079 | Stenosis, Pulmonary Artery |
| ID | Term |
|---|---|
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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