Safety and Efficacy of Bioresorbable Iron-Based Covered Stent System for the Treatment of Coarctation of the Aorta: A Single-Center Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- 1.Rate of no stent restenosis[Defined on a per target lesion basis]
研究概览
简要总结
A single-center, feasible clinical study to Evaluate the Treatment of Iron Bioresorbable Covered Scaffold System in patients with Coarctation of the Aorta Diseases
详细描述
There is a feasibility study. Ten subjects are intended to participate in this study and without control group. The Iron Bioresorbable Covered Scaffold System will be implanted surgically. Follow-up will be conducted at 1 month, 3 months, 6 months and 12 months post-procedure. The primary endpoint is the rate of no restenosis of the stent at 12 months post-procedure [Defined on a per target lesion basis]
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must between 1 and 60 years old
- •Patients being clinically diagnosed with CoA or patients with post-operative anastomotic stenosis after CoA surgery，meanwhile meeting one of the following conditions:
- •A：Pressure gradient of Carctation in a calm state. B：The degree of aortic stenosis is not less than 50% (degree of Carctation Of the Arota = (diameter of adjacent normal segment of blood vessel - residual vessel lumen diameter of stenotic segment)
- •diameter of adjacent normal segment of blood vessel×100% ) C：Peak velocity of echocardiographic Doppler in the CoA≥2.5m/s
- •The patients and their families have high compliance, sign the informed consent and willing to undergo 1-year follow-ups and related examinations.
- •The patient's expected lifespan is more than one year after successful treatment with the stent.
- •Reference vessel (diameter of the adjacent normal segment vessel ) diameter：4-16mm
排除标准
- •Patients with a history of 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 and the distal or proximal location of the lesion.
- •Patients with known severe renal or hepatic insufficiency, which are unsuitable for index procedure
- •Target lesion to be treated where stent was implanted previously.
- •Patients with severe stenosis or excessive tortuosity in the targeted vessel, or anatomical abnormalities, which predict the device will have difficulty reaching the target lesion.
- •Other conditions that are unfavorable for stent delivery or balloon expansion.
- •Patient who have already participated in another clinical trial, and 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
1.Rate of no stent restenosis[Defined on a per target lesion basis]
时间窗: at 12 months post-procedure
Definition of stent restenosis: If the pressure difference within the stent on transthoracic echocardiography is 50% higher than the result of transthoracic echocardiography at 0-1 days post-procedure, will be considered as suspected restenosis.
2.Acute Procedure Success
时间窗: after the stent is delivered to the target lesion site and expanded during the procedure
Definition of Acute Procedure Success：Meeting any one of the following standards after the stent is delivered to the target lesion site and expanded during the procedure A.The pressure difference between the proximal and distal ends of the stenosis decreased by≥50% ,detected by right heart catheterization after the stent being placed. B.The inner diameter of the original stenotic segment of the blood vessel increases by ≥50% after the stent is placed，detected by pulmonary artery angiography after the stent being placed.
次要结局
- 1.Acute Technical Success(after the stent is delivered to the target lesion site and expanded during the procedure)
- 2.Rate of no stent restenosis(at 1,3, 6 months post-index procedure)
- 3.The rate of device related Major Adverse Events ( MAE ) and Serious Adverse Events（SAE）(at 1,3, 6, 12months post-index procedure)
- 4.The rate of unexpected secondary surgical or interventional procedures(at 1,3, 6, 12months post-index procedure)
- 5.Rate of Stent Thrombosis(at 1,3, 6, 12months post-index procedure)
- 6.Rate of all-cause mortality(at 1,3, 6, 12months post-index procedure)
- 7.The rate of displacement after stent implantation(at 1,3, 6, 12months post-index procedure)
- 8.The rate of Major Adverse Events ( MAE ) and Serious Adverse Events（SAE）during the study(at 1,3, 6, 12months post-index procedure)
研究者
Shubo Song
Associate Chief Physician
Chinese Academy of Medical Sciences, Fuwai Hospital