NCT02365454已完成不适用
Feasibility Clinical Study to Evaluate the Safety and Performance of the NEXUS™ Aortic Arch Stent Graft System
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 4
- 主要终点
- Safety: Device related mortality at 30 days post implantation
研究概览
简要总结
A multicenter, prospective, open-label, non-randomized, interventional clinical study, sponsored by Endospan Ltd. Patients will be followed-up for five years.
详细描述
The purpose of the study is to evaluate the safety and performance of the Nexus™ Aortic Arch Stent Graft System for the endovascular treatment of thoracic aortic pathologies requiring landing in the Aortic Arch (zone 0, zone 1, zone 2).
The Nexus™ Aortic Arch Stent Graft System is indicated for the endovascular treatment of thoracic aortic pathologies involving the aortic arch (such as aneurisms and dissections). The Nexus™ is intended to exclude the lesion from the blood circulation in patients diagnosed with thoracic aortic pathology and who have appropriate anatomy to accommodate the Nexus™ system in an endovascular procedure.
The primary objectives of the study are to evaluate the safety and performance of the Nexus™ Aortic Arch Aneurysm Stent Graft System.
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 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female age ≥
- •Any Thoracic Aorta pathology requiring landing in the Aortic Arch (zone 0, zone 1, zone2), e.g. aneurysm, dissection, false/Pseudo aneurysm.
- •In patient with a thoracic aneurysm: dilatation of the aortic arch larger than 5.5cm in diameter, or symptomatic aneurysm of the aortic arch, or aortic diameter growth rate > 5mm per 6 months
- •Patient is considered an appropriate candidate for an elective surgery, as evaluated by Physical Status Classification System I, II or III (American Society of Anesthesiologists).
- •Femoral artery diameter as documented by CTA or MRA that allows endovascular access to the diseased site with a 20-22Fr delivery catheter.
- •Access vessels morphology suitable for endovascular repair in terms of tortuosity, calcification and angulation, documented by CTA, MRA.
- •Access vessel (femoral/iliac) diameter > 7 mm
- •Ascending Aorta landing zone length > 30 mm
- •Brachial/Axial Artery diameter > 3 mm
- •Patient understands and is voluntarily willing to participate as evidenced by personally signing the Informed Consent document, and willingness to comply with follow-up schedule
排除标准
- •Female is of childbearing potential
- •Life expectancy of less than 1 year
- •Any medical condition that, according to the investigator's decision, might expose the patient to increased risk by the investigational device or procedure.
- •Acutely ruptured or instable aneurysm or an acute vascular injury due to trauma or infected penetrating ulcers of the aorta.
- •Patient with an increased risk for aneurysm rupture during the procedure.
- •Patient whose arterial access site is not anticipated to accommodate the access of the Nexus™ Delivery System, due to size, tortuosity or hostile groins (scarring, obesity, or previous failed puncture)
- •Patients with severe atherosclerosis or intraluminal thrombus of the aorta or in the BCT
- •Patient is suffering from unstable angina or NYHA classification III and IV and/or ASA classification IV and above.
- •Patient has had a myocardial infarction (MI) or cerebral vascular accident (CVA) within 3 months prior to the planned implantation
- •Patient has a known hypersensitivity or contraindication to anticoagulants, antiplatelets, or contrast media, which is not amenable to pre-treatment.
- •Patient with a contraindication to undergo angiography
- •Patient with known sensitivities or allergies to the device materials- Nitinol and polyester
- •Clinical conditions that severely inhibit x-ray visualization of the Aorta.
- •Connective tissue disease (e.g., Marfan's or Ehler's-Danlos syndromes)
- •Patient has history of bleeding diathesis or coagulopathy that may limit the use of dual antiplatelet or anticoagulant therapy by the decision of the investigator
- •Patient has an active systemic infection at the time of the procedure documented by pain, fever, drainage, positive culture and/or leukocytosis (WBC > 11,000 mm3).
- •Patients who have the condition that threatens to infect the stent graft.
- •Acute renal failure; chronic renal failure (excluding dialysis); Creatinine > 2.00 mg/dl or > 182 umol/L
- •Patient underwent major surgery or interventional procedure in the last three months.
- •Any other medical, social, or psychological issues that in the opinion of the investigator preclude them from receiving this treatment, or the procedures and evaluations pre- and post- treatment.
- •Active participation in another clinical trial that is reasonable to conflict with the NexusTM study.
研究组 & 干预措施
Thoracic Aortic Disease Single Arm Study
Experimental
Thoracic Aortic Disease treated by Stent Graft Placement
干预措施: Stent Graft Placement (Nexus) (Device)
结局指标
主要结局
Safety: Device related mortality at 30 days post implantation
时间窗: 30 days
次要结局
- Safety: Device related re-intervention within 1 year from implantation(1 year)
研究者
研究点 (4)
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