NCT04973540招募中不适用
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
Biotyx Medical (Shenzhen) Co., Ltd.10 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2021年7月13日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 82
- 试验地点
- 10
- 主要终点
- Rate of procedural success
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patients who have a history of disease related to iron overload or iron disorder, such as hereditary hemochromatosis, etc.
- •Patients with cardiopulmonary function that cannot tolerate surgery, such as severe heart failure (NYHA Grade III and above) that cannot be controlled by active medical treatment.
- •Patients with known allergy to contrast agent, iron and its degradation products.
- •Patients with hemorrhagic disorders.
- •Patients with contraindications on antiplatelet agents and anticoagulant therapy.
- •Patients with thrombosis at the vascular wall of target lesion or the distal or proximal location.
- •Patients with known severe renal or hepatic insufficiency which are unsuitable for index procedure as per investigator judgement.
- •Previous stent implantation has been performed to treat the target lesion;
- •Patients with severe stenosis or excessive tortuosity in the targeted vessels, or anatomical abnormalities, making it difficult for device to reach the target lesion.
- •Other conditions that are not suitable for stent delivery or balloon expansion.
- •Patient who have already participated in another drug or medical device clinical trial that have not yet completed or withdrawn within 3 months before the screening period of this trial.
- •Patients who are not suitable for participating the trial as per investigator judgement.
结局指标
主要结局
Rate of procedural success
时间窗: Immediately post-procedure
Defined on a per target lesion basis.
Rate of freedom from in-stent restenosis
时间窗: 12 months
Defined on a per target lesion basis.
次要结局
- Rate of device-related serious adverse events(24 months)
- Rate of technical success(Immediately post-procedure)
- Rate of adverse events(24 months)
- Rate of device deficiency(Day 0)
- Rate of freedom from in-stent restenosis(6 months)
- Rate of device-related adverse events(24 months)
- Rate of unplanned surgery or re-intervention(24 months)
- Rate of stent thrombosis(24 months)
- Rate of all-cause death(24 months)
- Rate of stent displacement(12 months)
- Rate of serious adverse events(24 months)
研究者
研究点 (10)
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