NCT04731636已完成不适用
Guo's Visceral Arteries Reconstruction :The First in Man Study of G-Branch Multiple Branch Stent Graft System.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Number of Participants With Major Adverse Events (MAE) Within 30 Days Postoperative
研究概览
简要总结
A First in man study to evaluate the safety and efficacy of thoracoabdominal aortic stent system for thoracoabdominal aortic aneurysms and pararenal abdominal aortic aneurysm.
详细描述
The study is mainly for patients with Crawford type I-V thoracoabdominal aortic aneurysms and pararenal abdominal aortic aneurysm, and all subjects who passed the screening and signed the informed consent will be enrolled. Patients who meet all the inclusion criteria and don't meet the exclusion criteria will be implanted with thoracoabdominal aortic stent system.
Patients will be followed up at discharge, 1 month, 6 months, 12 months after the implantation.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 and ≤80 years;
- •Patients diagnosed with type Crawford I-V thoracoabdominal aortic aneurysmsa and pararenal abdominal aortic aneurysm, and should meet at least one of the following conditions:
- •The maximum diameter of thoracoabdominal aortic aneurysms and pararenal abdorminal aortic aneurysm > 50 mm;
- •Rapid growth of sac >5 mm in diameter in the most recent 6 months;
- •Definite symptoms of abdominal pain and low back pain associated with thoracicabdominal aortic aneurysms.
- •Patients with four indispensable reno-visceral arteries including superior mesenteric artery, celiac trunk and bilaterial renal arteries.
- •Proximal landing zone 20-36 mm in diameter;
- •Proximal landing zone ≥25 mm in length;
- •If distal landing zone in abdominal aorta, distal landing zone should be 12-36mm in diameter and ≥15 mm in length.
- •The visceral vascular branches landing zone 6~13 mm in diameter and ≥15 mm in length;
- •The renal artery landing zone 4.5~9 mm in diameter and ≥15 mm in length;
- •Patients who using the abdominal aortic bifurcation stent graft system should also meet the following criteria:
- •The ilac artery landing zone 7 ~25 mm in diameter;
- •The ilac artery landing zone ≥15 mm in length;
- •Patients with appropriate iliacofemoral access and at least one patent upper extremity access;
- •Patients who can understand the purpose of the trial, volunntarily participate and sign the informed consent form, and are willing to complete the follow-up according to the requirements of the protocol;
排除标准
- •Ruptured aortic aneurysm in unstable haemodynamic condition;
- •Aneurysmal aortic dissection;
- •Infected or mycotic aortic aneurysm;
- •Requiring simultaneous coverage or embolisation for bilateral internal iliac arteries;
- •Severe stenosis, calcification, or mural thrombus at stent-graft landing zone;
- •Diagnosis of acute coronary syndrome within 6 months;
- •Patients with any transient ischemic attack (TIA) or ischemic stroke within 3 months;
- •An allergic history for contrast agents, anticoagulants, antiplatelet drugs, stent graft or materials of delivery system；
- •Patients with connective tissue diseases;
- •Patients with takayasu arteritis;
- •Patients with serious vital organ dysfunction or other serious disease;
- •Preoperative liver renal function abnormalities (ALT or AST ≥ 5 times the upper limit of normal value), or serum creatinine ≥ 150 μmol/L;
- •Severe pulmonary insufficiency who cannot tolerate general anaesthesia;
- •Severe coagulation dysfunction;
- •Undergone major surgical or interventionic surgery within 30 days before surgery;
- •Patients whose systemic or local infection may increase the risk of intravascular graft infection;
- •Planning pregnancy, pregnancy, or breastfeeding;
- •The patient participated in other clinical trials or not completed or withdrawn from other clinical trials within the last 3 months at the time of screening period ;
- •Life expectancy less than 1 year;
- •Patients not appropriate for endovascular repair based on the investigators' clinical judgement.
结局指标
主要结局
Number of Participants With Major Adverse Events (MAE) Within 30 Days Postoperative
时间窗: within 30-days postoperative
Major Adverse events (MAE) are defined as all-cause death, liver failure, intestinal necrosis, splenic infarction, renal infarction, renal failure, cerebral infarction, paraplegia, myocardial infarction, and respiratory failure.
次要结局
未报告次要终点
研究者
XuWei
Project manager
Lifetech Scientific (Shenzhen) Co., Ltd.
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Thoracoabdominal Aortic Stent System for Endovascular Treatment of Thoracoabdominal Aortic Dissecting Aneurysm.Aortic, Aneurysm, Dissecting ThoracoabdominalNCT05803564Lifetech Scientific (Shenzhen) Co., Ltd.46
Unknown
不适用
Guo's Visceral Arteries Reconstruction :The First in Man Study of WeFlow-JAAA Stent Graft SystemJuxta Renal Abdominal Aortic Aneurysm Without RuptureNCT04745546Hangzhou Endonom Medtech Co., Ltd.15
招募中
不适用
Safety and Efficacy of a Multi-branched Thoracoabdominal Stent Graft System for Thoracoabdominal Aortic Aneurysm.Thoracoabdominal Aortic AneurysmsNCT05054985Lifetech Scientific (Shenzhen) Co., Ltd.73
已完成
不适用
Guo's Aortic Arch Reconstruction: The First in Man Study of WeFlow-Arch Modular Embedded Branch Stent Graft SystemAortic Arch Aneurysm, DissectingNCT04764370Hangzhou Endonom Medtech Co., Ltd.8
已完成
2 期
ARBITER-II: Aorfix™ Bifurcated Safety and Performance Trial: Phase II, Angulated VesselsAbdominal Aortic AneurysmNCT00442065Lombard Medical30