NCT05874206招募中不适用
Evaluation of Cratos™ Branch Stent Graft System in Treatment of Descending Aorta Lesions
Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2024年3月8日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
The goal of this prospective, interventional, multicentre, single-arm performance objective study is to evaluate efficacy and safety of Cratos™ Branch Stent Graft System in treatment of lesions (dissection, IMH and PAU in descending aorta. The main question[s] it aims to answer are:
-
30-day all-cause Mortality rate
-
Composite of the following events from the time of enrolment through 12-month:
-
Device Technical Success
-
Absence of: Aortic rupture, Lesion-related mortality, Disabling Stroke, Permanent paraplegia, Permanent paraparesis, New onset renal failure requiring permanent dialysis, Additional unanticipated post-procedural surgical or interventional procedure related to the device, procedure, or withdrawal of the device system
Participants will come for hospital office visits 1, 6, 12, 24-, 36-, 48- and 60-months post-procedure for the following, but not limited to assessments:
- Physical examination
- Modified Rankin scale
- Tarlov scoring scale
- CTA
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Presence of thoracic aortic pathology (Dissection, including IMH and ULP; and PAU) deemed to warrant surgical repair which requires proximal graft placement in Zone 2
- •Age ≥18 years at time of informed consent signature
- •Informed Consent Form (ICF) is signed by Subject or legal representative
- •Must have appropriate proximal aortic landing zone, defined as:
- •Landing zone inner diameters between 23-41 mm
- •The length of landing zone ≥15mm
- •Landing without heavily calcified or heavily thrombosed
- •Dissection Patients: Primary entry tear must be distal to LSA, and proximal extent of the proximal landing zone must not be dissected.
- •For patients with prior replacement of the ascending aorta and/or aortic arch by a surgical graft, there must be at least 2 cm of landing zone proximal to the most distal anastomosis site.
- •Must have appropriate LSA landing zone, defined as:
- •Inner diameters of LSA 5-14 mm
- •Minimum length of Left subclavian artery is 25 mm
- •Target branch vessel landing zone must be in native aorta that cannot be severely tortuous , aneurysmal, dissected, heavily calcified, or heavily thrombosed.
- •Must have appropriate distal aortic landing zone, defined as:
- •Aortic inner diameters between 18-44 mm
- •Landing zone cannot be heavily calcified, or heavily thrombosed.
- •For isolated PAU, outer curvature length must be ≥ 2cm proximal to the celiac artery
- •Landing zone in native aorta
排除标准
- •Concomitant disease of the ascending aorta or aneurysm of the abdominal aorta requiring repair
- •Previous endovascular repair of the ascending aorta
- •Infected aorta, active systemic infection
- •Surgery within 30 days prior to enrolment with the exception of placement of vascular conduit for access .
- •Life expectancy <1 years
- •Myocardial infarction within 6 weeks prior to treatment
- •Stroke within 6 weeks prior to treatment.
- •Pregnant or breastfeeding female
- •Patient has an active systemic infection (e.g., infection requiring treatment with parenteral anti-infective medication) that may place the patient at increased risk of endovascular infection.
- •Degenerative connective tissue disease, e.g., Marfan's or Ehlers-Danlos Syndrome
- •Participation in another drug or medical device study within one year of study enrolment
- •Known history of drug abuse within one year of treatment
- •Tortuous or stenotic iliac and/or femoral arteries preventing introducer sheath insertion and the inability to use a conduit for vascular access
- •Planned coverage of celiac artery
- •Allergic to contrast agents, anaesthetics and delivery materials
- •Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin
- •Patient with a history of a hypercoagulability disorder and/or is currently in a hypercoagulability state
- •Persistent refractory shock (systolic blood pressure <90 mm Hg)
- •Renal failure defined as patients with an estimated Glomerular Filtration Rate (eGFR) <30 (ml/min/1.73 m2) or currently requiring dialysis
- •Contraindications to antiplatelet drugs and anticoagulants
- •Investigator judged that not suitable for interventional treatment.
研究组 & 干预措施
TEVAR
Experimental
Thoracic Endovascular Repair (TEVAR) provides a minimally invasive treatment option for descending thoracic aorta (DTA) pathologies.
干预措施: Cratos™ Stent Graft (Device)
结局指标
主要结局
Mortality
时间窗: 30-day
All-cause mortality
次要结局
未报告次要终点
研究者
研究点 (1)
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