Prospective Study for Aortic Arch Therapy With stENt-graft for Chimney technologY：A Prospective, Multi-center, Objective Performance Criteria Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 21
- 主要终点
- The treatment success rate of aortic dissection at 12 months post-implant
研究概览
简要总结
A prospective, multi-centre, objective performance criteria clinical trial to evaluate the safety and efficacy of Artery Stent Graft System manufactured by Lifetech Scientific (Shenzhen) Co., LTD. for the thoracic aortic dissection involving the aortic arch.
详细描述
This clinical trial was conducted in a qualified clinical trial institution. Investigators will use Artery Stent Graft System manufactured by Lifetech Scientific (Shenzhen) Co., LTD. to treat patients with thoracic aortic dissection involving the aortic arch. This is a Prospective, Multi-center, Objective Performance Criteria Clinical Trial. It is expected to submit to the ethics committee of the lead unit for review in Sep 2018, and complete the implantation of 150 patients in 18 centres nationwide within 12 months, and interim follow-up was conducted before discharge, 30 days after surgery, 6 months after surgery and 12 months after surgery, long-term follow-up will be performed at 24 months postoperatively, 36 months postoperatively, 48 months postoperatively and 60 months postoperatively.
This trial will evaluate whether the device reached the primary safety endpoint and primary efficacy endpoint through two primary endpoint indicators: the incidence of major adverse events (MAE) within 30 days and the success rate of aortic dissection treatment 12 months after surgery.
This trail will evaluate whether the device reached the secondary safety endpoint and efficacy endpoint through several secondary endpoint indicators:
- the incidence of all-cause death at 30 days, 6 months, 12 months and 2-5 years after surgery
- the incidence of thoracic aortic dissection-related death at 30 days, 6 months, 12 months and 2-5 years after surgery
- the incidence of severe adverse events (SAE) at 30 days, 6 months, 12 months and 2-5 years after surgery
- the incidence of the device-related adverse events (AE) at 30 days, 6 months, 12 months and 2-5 years after surgery
- the Incidence of left upper limb ischemia at 30 days, 6 months, 12 months and 2-5 years after surgery
- the incidence of type I or type III leakage at 30 days, 6 months, 12 months after surgery
- the incidence of graft migration at 30 days, 6 months, 12 months after surgery
- the branching vascular patency rate at 30 days, 6 months, 12 months after surgery
- the Incidence of Thoracic aortic dissection -related surgical conversion or re-intervention at 30 days, 6 months, 12 months and 2-5 years after surgery According to the guidelines for clinical trials of aortic stent system, the sponsor will apply for NMPA listing registration after completing a 12-month primary endpoint assessment, and annually follow-up will be conducted until the fifth year for the long-term efficacy observation.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are 18 years and older, but less than 85 years old and not pregnant or lactating;
- •Patients who can understand the purpose of the trial, voluntarily participate in and sign the informed consent, and are willing to complete the follow-up according to the requirements of the protocol;
- •Patients diagnosed as thoracic aortic dissection involving the arch, and the left subclavian artery branching vessel needs to be revascularized;
- •Aortic proximal landing zone ≥15mm；
- •Aortic proximal diameter in the range of 25-44mm;
- •The left subclavian artery distal landing zone≥15mm;
- •The left subclavian artery diameter in the range of 5-18mm；
- •Patients who have eligible imported arterial vessels.
排除标准
- •Patients with severe stenosis, calcification in the landing area of the stent and easily lead to incomplete stent apposition;
- •Patients need intervention for other vascular diseases (such as coronary artery /renal artery) in the same surgery, or patients with heart disease and medicine treatment will be affected by the intervention；
- •Patients with a history of myocardial infraction or acute coronary syndromes in 3 months；
- •Patients with a history of cerebrovascular events or gastrointestinal bleeding in 3 months, antiplatelet agent and anticoagulant contraindication, or tendency of hemorrhage；
- •Patients have received any major surgical or interventional therapy within 30 days (Operation Classification reaches III or above) or have received interventional therapy;
- •Patients will receive any major selective operation or interventional therapy in 30days (Operation Classification reaches III or above) or will received interventional therapy;
- •Patients already treated with an thoracic aortic stent graft and the stent graft can affect operation or intersection part existing between the graft covering area；
- •Patients with genetic connective tissue disease (e.g., Marfans syndrome) or aorta hereditary disease；
- •Patients with infectious aortic dissection;
- •Patients with acute systemic infection;
- •Patients with major organ failure or other serious diseases;
- •Patients with a history of active bleeding, clotting disorder, or rejection of blood transfusions;
- •Patients with liver dysfunction: preoperative creatinine was 2.5 times higher than the normal upper limit; Alanine transaminase (ALT) or Aspartate transaminase (AST) were 5 times higher than the normal upper limit; serum total bilirubin (STB) was 2 times higher than the normal upper limit;
- •Pregnant or lactating women or women who plan to get pregnant;
- •Patients who can not tolerate to Anaesthetic；
- •Patients with a history of allergy to contrast media, stents and conveyor materials (including nickel and titanium, polyester, PTFE, and nylon polymer materials);
- •Patients with a life expectancy less than 12 months（such as terminal malignant tumor）；
- •Patients who were not suitable for endovascular treatment, judged by the investigator;
- •Patients who participated in clinical trials of other drugs or medical devices at the same time.
结局指标
主要结局
The treatment success rate of aortic dissection at 12 months post-implant
时间窗: 12 months after surgery
Assessment of the rate of successful disease treatment defined as immediate technical success and freedom from secondary intervention at 12 months of follow-up. Technique success means delivery system is successfully transported to the predetermined position, both of aorta stent graft and aortic branch stent graft successfully expanded and delivery system withdraw successfully.No type I/III endoleak at the end of operation, no conversion to open surgery. (Adjuvant Interventions during operation do not defined as technical failure.)
Incidence of no major adverse events (MAE) occurred at 30 days post-implant
时间窗: 30 days after surgery
Major Adverse events (MAE) are defined as aortic dissection related mortality, ischemic stroke, and paraplegia.
次要结局
- Branching vascular patency rate(30 days，6 months, 12 months and 2-5 years after surgery)
- Incidence of Thoracic aortic dissection -related surgical conversion or re-intervention(30 days，6 months, 12 months and 2-5 years after surgery)
- Incidence of all-cause death(30 days，6 months, 12 months and 2-5 years after surgery)
- Incidence of Aortic dissection dissection-related death(30 days，6 months, 12 months and 2-5 years after surgery)
- Incidence of Serious Major Adverse Event（SAE）(30 days，6 months, 12 months and 2-5 years after surgery)
- Incidence of device related adverse events（AE）(30 days，6 months, 12 months and 2-5 years after surgery)
- Incidence of left upper limb ischemia(30 days，6 months, 12 months and 2-5 years after surgery)
- Incidence of I/III type endoleaks(30 days，6 months, 12 months and 2-5 years after surgery)
- Incidence of graft migration(30 days，6 months, 12 months and 2-5 years after surgery)