NCT07139912尚未招募不适用
Prospective, Multicenter, Single-Arm Trial Assessing Safety/Effectiveness of Multi-Branch Thoracic Stent Grafts in Aortic Arch Disease
Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2025年9月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- 12-month treatment success rate
研究概览
简要总结
A prospective ,multiple center Study about the Safety and Efficacy of the Thoracic Aortic Multi-Branch Stent Graft System, developed and manufactured by Shanghai MicroPort Endovascular MedTech (Group) Co., Ltd., in patients with aortic arch pathologies.
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
- •Aged 18 to 80 years
- •Diagnosed with aortic arch pathology requiring intervention, including:
- •True aortic arch aneurysm
- •Pseudoaneurysm of the aortic arch
- •Penetrating aortic ulcer involving the arch
- •Deemed suitable for endovascular repair by the investigating physician
- •Capable of understanding study objectives, providing written informed consent, and complying with follow-up requirements
- •Anatomic suitability confirmed by CTA:
- •Ascending aortic length ≥50 mm
- •Ascending aortic diameter ≥26 mm and ≤46 mm
- •Proximal landing zone length ≥20 mm
- •Brachiocephalic trunk diameter ≥9 mm and ≤19 mm with length ≥20 mm
- •Left common carotid artery (LCCA) and left subclavian artery (LSA) diameters ≥5 mm and ≤13 mm
- •LCCA length ≥20 mm
- •Distance from LSA ostium to left vertebral artery origin ≥20 mm
- •High surgical risk per investigator assessment OR contraindicated for open surgery
排除标准
- •Pregnant or lactating women
- •Connective tissue disorders affecting the aorta (e.g., Marfan syndrome, Ehlers-Danlos syndrome)
- •Infected aortic pathologies or aortitis (e.g., mycotic aneurysm, Takayasu arteritis)
- •Prior endovascular repair of ascending aorta/aortic arch
- •Documented allergy to nitinol, contrast media, or device materials
- •Severe renal impairment:(Serum creatinine >2×ULN,Excluding dialysis-dependent patients)
- •Hematologic abnormalities:(WBC <3×10⁹/L、Hb <70 g/L、PLT <50×10⁹/L)
- •Heart transplant recipients
- •Myocardial infarction or stroke within 3 months
- •NYHA Class IV heart failure
- •Active systemic infection (e.g., bacteremia, sepsis)
- •Life expectancy <12 months
- •Mechanical aortic valve prosthesis impeding device delivery
- •Current participation in other interventional trials with primary endpoint pending
- •Anticipated poor compliance with follow-up
- •Other contraindications for endovascular repair per investigator assessment:Severe vascular stenosis/calcification/tortuosity/Thrombus at landing zones/Inability to cooperate with procedure
结局指标
主要结局
12-month treatment success rate
时间窗: 12-month
Technical success at the index procedure, without device- or aortic pathology-related mortality or unplanned secondary interventions, and with no evidence of persistent enlargement of the treated aortic segment due to Type I/III endoleaks on 12-month CTA follow-up.
30-day rate of Major Adverse Events (MAE)
时间窗: 30-day
Including all-cause mortality, disabling stroke, persistent paraplegia, renal failure, myocardial infarction, and respiratory failure
次要结局
未报告次要终点
研究者
研究点 (1)
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