NCT03287024进行中（未招募）不适用
Prospective, Multicenter, Single-arm Study to Assess the Safety and Performance of the BeGrow Stent System in Newborns and Infants to Treat Pulmonary Artery Stenosis
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 18
- 试验地点
- 3
- 主要终点
- Incidence of serious adverse events device and procedure related
研究概览
简要总结
Objective of the study is to assess safety and performance of the BeGrow Stent System for newborns and infants in pulmonary artery stenosis.
详细描述
The Bentley InnoMed "BeGrow Stent System for Newborns and Infants" is a stent delivery system indicated for intraluminal placement in the pulmonary arteries of newborns and infants for the treatment of Pulmonary Artery Stenosis.
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
- — 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Single lesion(s) which can be treated with a 6 mm BeGrow stent (only one stent per lesion allowed).
- •Pulmonary artery stenosis - patient must at least have one of the following diseases:
- •Haemodynamically relevant proximal or distal branch pulmonary artery stenosis with a reduction of the vessel diameter when the vessel/patient is large enough to accommodate a stent,
- •Haemodynamically relevant stenosis of the main pulmonary artery segment that results in elevation of the Right Ventricle (RV) pressure, provided that the stent definitely will not compromise a functioning pulmonary valve and will not impinge on the pulmonary artery bifurcation,
- •Any degree of stenosis in patients with single ventricle circulation
- •Critically ill postoperative cardiac patients when it has been determined that branch pulmonary artery stenosis is resulting in a definite haemodynamic compromise in a patient/vessel of any size, particularly if balloon dilatation is unsuccessful
- •Signed written informed consent (by parents/legal guardians)
- •Lesion can be accessed with a guide wire or balloon catheter
- •Age ≤ 24 months and weight ≥ 2 kg
- •Adequate stent length available
排除标准
- •The following lesions are excluded from treatment with BeGrow stent:
- •Shunt stenosis
- •Valvular and subvalvular pulmonary stenosis
- •Patients with known hypersensitivity to the stent material (L605 cobalt-chromium).
- •Patients with clinical or biological signs of infection.
- •Patients with active endocarditis.
- •Patients with known allergy to acetylsalicylic acid, other antiplatelet agents or heparin.
- •Presence of other previously implanted stents in the same lesion or in close proximity to stent (direct stent-stent contact).
- •Patients with known coagulation disorder.
- •Patients where direct stent-stent contact or overlapping cannot be avoided.
- •Patients where contact to the vessel wall over the entire stent length cannot be ensured after dilatation (especially in short and thick lesions).
- •Patients where the BeGrow stent could protrude freely into adjacent vessels after expansion/dilatation, including the pulmonary arterial bifurcation.
- •Implantation of the BeGrow stent in the pulmonary arterial bifurcation.
研究组 & 干预措施
BeGrow Stent System
Experimental
All enrolled subjects will receive the BeGrow Stent System
干预措施: BeGrow Stent System (Device)
结局指标
主要结局
Incidence of serious adverse events device and procedure related
时间窗: 12 Months
Incidence of SAE
Vessel enlargement in mm
时间窗: after procedure and during follow ups up to 12 Months
Vessel enlargement will be measured in mm, directly before and after stent implantation by angiography
次要结局
未报告次要终点
研究者
研究点 (3)
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