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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
82
Subjects in this arm will be implanted with IBS Angel.
The Second Xiangya Hospital of Central South University
Changsha, China
NOT_YET_RECRUITINGChildren's Hospital of Chongqing Medical University
Chongqing, China
NOT_YET_RECRUITINGRate of freedom from in-stent restenosis
Defined on a per target lesion basis.
Time frame: 12 months
Rate of procedural success
Defined on a per target lesion basis.
Time frame: Immediately post-procedure
Rate of technical success
Defined on a per target lesion basis.
Time frame: Immediately post-procedure
Rate of freedom from in-stent restenosis
Defined on a per target lesion basis.
Time frame: 1 month
Rate of freedom from in-stent restenosis
Defined on a per target lesion basis.
Time frame: 3 months
Rate of freedom from in-stent restenosis
Defined on a per target lesion basis.
Time frame: 6 months
Rate of device-related adverse events
Time frame: 1 month
Rate of device-related serious adverse events
Time frame: 1 month
Rate of device-related adverse events
Time frame: 3 months
Rate of device-related serious adverse events
Time frame: 3 months
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The People's Hospital of Gaozhou
Gaozhou, China
RECRUITINGGuangdong Provincial People's Hospital
Guangzhou, China
RECRUITINGFuwai Yunnan Cardiovascular Hospital
Kunming, China
NOT_YET_RECRUITINGShanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China
NOT_YET_RECRUITINGXinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China
NOT_YET_RECRUITINGGeneral Hospital of Northern Theater Command of Chinese People's Liberation Army
Shenyang, China
NOT_YET_RECRUITINGShenzhen Children's Hospital
Shenzhen, China
NOT_YET_RECRUITINGFuwai Central China Cardiovascular Hospital
Zhengzhou, China
NOT_YET_RECRUITINGRate of device-related adverse events
Time frame: 6 months
Rate of device-related serious adverse events
Time frame: 6 months
Rate of device-related adverse events
Time frame: 12 months
Rate of device-related serious adverse events
Time frame: 12 months
Rate of device-related adverse events
Time frame: 24 months
Rate of device-related serious adverse events
Time frame: 24 months
Rate of unplanned surgery or re-intervention
Time frame: 1 month
Rate of unplanned surgery or re-intervention
Time frame: 3 months
Rate of unplanned surgery or re-intervention
Time frame: 6 months
Rate of unplanned surgery or re-intervention
Time frame: 12 months
Rate of unplanned surgery or re-intervention
Time frame: 24 months
Rate of stent thrombosis
Time frame: 1 month
Rate of stent thrombosis
Time frame: 3 months
Rate of stent thrombosis
Time frame: 6 months
Rate of stent thrombosis
Time frame: 12 months
Rate of stent thrombosis
Time frame: 24 months
Rate of all-cause death
Time frame: 1 month
Rate of all-cause death
Time frame: 3 months
Rate of all-cause death
Time frame: 6 months
Rate of all-cause death
Time frame: 12 months
Rate of all-cause death
Time frame: 24 months
Rate of stent displacement
Time frame: 1 month
Rate of stent displacement
Time frame: 3 months
Rate of stent displacement
Time frame: 6 months
Rate of stent displacement
Time frame: 12 months
Rate of adverse events
Time frame: 1 month
Rate of serious adverse events
Time frame: 1 month
Rate of adverse events
Time frame: 3 months
Rate of serious adverse events
Time frame: 3 months
Rate of adverse events
Time frame: 6 months
Rate of serious adverse events
Time frame: 6 months
Rate of adverse events
Time frame: 12 months
Rate of serious adverse events
Time frame: 12 months
Rate of adverse events
Time frame: 24 months
Rate of serious adverse events
Time frame: 24 months
Rate of device deficiency
Time frame: Day 0