NCT04765592进行中（未招募）不适用
Guo's Aortic Arch Reconstruction :The Prospective ,Multiple Center Study About the Safety and Efficacy of WeFlow-Arch Modeler Embedded Branch Stent Graft System (GIANT Study)
Hangzhou Endonom Medtech Co., Ltd.23 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2021年6月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 88
- 试验地点
- 23
- 主要终点
- Rate of all-cause mortality and major stroke within 12 months after surgery
研究概览
简要总结
A prospective ,Multiple Center Study About the Safety and Efficacy of WeFlow-Arch Modeler Embedded Branch Stent Graft System manufactured by EndoNom Medtech (Hangzhou) Co., Ltd. for true/false aortic arch aneurysms and ulcers involving aortic arch . (GIANT Study)
详细描述
This study is a prospective ,multiple center study about the safety and efficacy of WeFlow-Arch Modeler Embedded Branch Stent Graft System, it is expected to complete the implantation of 80 patients in 23 centers 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.
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
- •Patients aged 18 to 80 years old;
- •Diagnosed with aortic arch lesions requiring intervention, including true aortic arch aneurysms, pseudo-aortic arch aneurysms, and ulcers involving the aortic arch;
- •Showing a suitable vascular condition, including:
- •Ascending aorta length greater than 50 mm (from the aortic sinusoid junction to the proximal cardiac margin of the innominate artery).
- •Ascending aorta diameter ≥ 24 mm and ≤ 48 mm;
- •Proximal anchoring zone length ≥ 30 mm;
- •Innominate artery diameter ≤ 24 mm and ≥ 7 mm, length ≥ 20 mm；
- •Left common carotid artery or left subclavian artery diameter ≤ 24 mm and ≥ 7 mm, length ≥ 20 mm；
- •Suitable arterial access for endovascular interventional treatment;
- •Able to understand the purpose of the trial, participate in the trial voluntarily with informed consent form signed by the patient him/herself or his or her legal representative, and willing to complete follow-up visits as required under the protocol.
- •Evaluated by at least two vascular surgeons or cardiac surgeons as high surgical risk patients or deemed to have significant surgical contraindications.
排除标准
- •Experienced systemic infection during past three months;
- •Neck surgery was performed within 3 months;
- •Previous endovascular interventional treatment involving the aortic arch was performed;
- •Infectious aortic disease、Takayasu arteritis，Marfan syndrome (or other connective tissue diseases );
- •Severe stenosis, calcification, thrombosis, or tortuosity of the carotid or subclavian artery;
- •Heart transplant;
- •Suffered MI or stroke during past three months;
- •Class IV heart function (NYHA classification);
- •Active peptic ulcers or upper gastrointestinal bleeding occurring within the previous three months;
- •Hematological abnormality, defined as follows: Leukopenia (WBC < 3 × 109/L), acute anemia (Hb < 90 g/L); thrombocytopenia (PLT count < 50 × 109/L), history of bleeding or coagulopathy;
- •Renal insufficiency， creatinine > 265 umol/L (or 3.0mg/dL) and/or end-stage renal disease requiring renal dialysis, as determined by an investigator after a thorough analysis;
- •Pregnant or breastfeeding;
- •Allergies to contrast agents;
- •Life expectancy of less than 12 months;
- •Participating in another drug or device research;
- •Any other disease or abnormality that the investigators believe may hinder endovascular interventional treatment.
结局指标
主要结局
Rate of all-cause mortality and major stroke within 12 months after surgery
时间窗: 12 months after surgery
All-cause mortality includes cardiac mortality, non-cardiac mortality, and mortality from unknown causes. Severe stroke is defined as a modified Rankin score (mRS) ≥ 2 at 90 days following stroke onset.
次要结局
- Rate of aortic aneurysm-related mortality(12 months post operation)
- Incidence of aortic arch stent graft displacement(1 month, 6 months, 12 months after operation)
- Incidence of surgically induced de novo aortic dissection converted to open-heart surgery or secondary intervention(30 days, 6 months, and 12 months after operation)
- Rate of major adverse events(30 days post operation)
- Rate of immediate technical success following surgery(immediately after the surgery)
- Rate of aortic aneurysm progression under control(12 months after operation)
- Incidence of Type I or Type III endoleak(immediately after the surgery, 1 month, 6 months, 12 months after the surgery)
- Postoperative branch vessel patency rate(1 month, 6 months, 12 months after operation)
- Incidence of severe adverse events(30 days, 6 months, and 12 months after operation)
- Incidence of device-related adverse events(30 days, 6 months, and 12 months after operation)
研究者
研究点 (23)
Loading locations...
相似试验
招募中
不适用
Guo's Aortic Arch Reconstruction: A Multicenter, Prospective Study of the Novel WeFlow-Tribranch System (GENIUS Study)Aortic Arch AneurysmNCT06385379Hangzhou Endonom Medtech Co., Ltd.90
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
Unknown
不适用
Total Endovascular Aortic Arch Re-construction Study(TEARS)Aorta DissectionAorta AneurysmNCT01496833Xijing Hospital50
已完成
不适用
Safety and Efficacy Study of WeFlow-JAAA Stent Graft System for Complex Abdominal Aortic Aneurysm(GREAT Study)Juxtarenal Abdominal Aortic AneurysmNCT05179967Hangzhou Endonom Medtech Co., Ltd.106
已完成
不适用
Guo's Visceral Arteries Reconstruction: First in Man StudyThoracoabdominal Aortic AneurysmPararenal Aortic AneurysmNCT04731636Lifetech Scientific (Shenzhen) Co., Ltd.15