Safety and Efficacy of the Triple Branched Covered Stent Graft System for the Treatment of Aortic Arch Lesions: a Prospective, Multicenter, Single-Arm Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 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
The goal of this clinical trial is to evaluate the safety and efficacy of the Triple Branched Covered Stent Graft System in treating aortic arch lesions. The main questions it aims to answer are:
- Does the Triple Branched Covered Stent Graft System achieve a 12-month treatment success rate that meets or exceeds the predefined target value?
- What is the 30-day major adverse event (MAE) rate following the use of the Triple Branched Covered Stent Graft System?
Researchers will use a single-arm study design with predefined target values for the primary endpoints to assess the performance of the stent system.
Participants will:
- Undergo a comprehensive screening process to determine eligibility based on specific inclusion and exclusion criteria.
- Receive the Triple Branched Covered Stent Graft System implantation as part of the treatment for their aortic arch lesions.
- Attend follow-up visits at specified intervals (e.g., pre-discharge, 30 days post-surgery, 6 months, 12 months, and annually up to 5 years) for evaluations including imaging studies (CTA) and clinical assessments.
- Report any adverse events or changes in their health status during the follow-up period.
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
- •Inclusion Criteria：
- •Patients aged 18-80 years.
- •Diagnosed with aortic arch lesions that require treatment, including true aortic arch aneurysms, false aortic arch aneurysms, and aortic arch ulcers.
- •The investigator determines that the subject is suitable for endovascular therapy.
- •The subject understands the purpose of the trial, voluntarily agrees to participate, and is willing to undergo follow-up.
- •Anatomical conditions:
- •Ascending aorta length ≥50 mm.
- •Ascending aorta diameter ≥26 mm and ≤46 mm.
- •Proximal landing zone length ≥20 mm.
- •Brachiocephalic artery diameter ≤19 mm and ≥9 mm, with a length ≥20 mm.
- •Left common carotid artery and left subclavian artery diameter ≤13 mm and ≥5 mm, with a left common carotid artery length ≥20 mm, and the distance from the left vertebral artery opening to the left subclavian artery opening on the aorta ≥20 mm.
- •The investigator assesses the subject as a high-risk patient for open surgery or with significant contraindications to open surgery.
排除标准
- •Pregnant or breastfeeding women.
- •Patients diagnosed with connective tissue diseases related to the aorta (e.g., Marfan syndrome).
- •Infectious aortic diseases or Takayasu arteritis.
- •Patients who have undergone endovascular treatment of the ascending aorta or aortic arch.
- •Patients with a known allergy to nickel-titanium alloy, contrast agents, or other relevant materials.
- •Severe renal failure (creatinine levels more than twice the upper limit of normal; dialysis patients are excluded).
- •Hematological abnormalities:
- •Leukopenia (WBC < 3×10⁹/L).
- •Anemia (Hb < 70 g/L).
- •Coagulation disorders: thrombocytopenia (PLT count < 50×10⁹/L).
- •Heart transplant recipients.
- •History of myocardial infarction or stroke within the past 3 months.
- •Heart function class IV (NYHA classification).
- •Active infections, such as bacteremia or sepsis.
- •Patients with an expected survival of less than 12 months.
- •Patients with aortic valve replacement with a mechanical valve that would interfere with the safe introduction of the trial device.
- •Subjects participating in other drug or medical device clinical trials and have not yet completed the primary endpoints of those trials.
- •Poor compliance, with an expectation of inability to attend follow-up visits.
- •Other conditions deemed by the investigator as unsuitable for endovascular therapy, such as severe vascular stenosis, calcification, tortuosity, thrombosis, or inability to cooperate.
结局指标
主要结局
12-month Treatment Success Rate
时间窗: 12 months postoperatively
Definition: Treatment success at 12 months is defined as immediate technical success, with no device/aneurysm-related death or unplanned secondary intervention postoperatively, and no increase in the diameter of the treated aorta segment (aneurysm or ulcer lesion diameter increased by ≥5mm) due to type I/III endoleak on CTA imaging follow-up at 12 months.
30-day Major Adverse Event Rate
时间窗: 30 days postoperatively
Any of the following events occurring within 30 days: 1.All-cause death: Any death from any cause within 30 days. 2.Disabling stroke: Defined as a Modified Rankin Scale (MRS) score ≥2 due to neurological deficits, with an increase of at least one grade from baseline. 3.Persistent paraplegia: Defined as a spinal ischemia grade ≥3 according to the spinal ischemia grading system. 4.Renal failure: New-onset persistent renal failure with a creatinine increase of more than 50% above preoperative levels, requiring dialysis. 5.Myocardial infarction: Clinically diagnosed as a new acute myocardial infarction, or requiring Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Grafting (CABG). 6.Respiratory failure: Intubation for more than 1 week during hospitalization.
次要结局
- Immediate Technical Success Rate(Immediately after the surgery)
- Branch Stent Patency Rate(pre-discharge, at 30 days, 6 months, 12 months, and annually at 2, 3, 4, and 5 years postoperatively)
- All-cause Mortality Rate(pre-discharge, at 30 days, 6 months, 12 months, and annually at 2, 3, 4, and 5 years postoperatively)
- Secondary Intervention Incidence Rate(pre-discharge, at 30 days, 6 months, 12 months, and annually at 2, 3, 4, and 5 years postoperatively)
- Stent Fracture/Twist/Collapse Incidence Rate(pre-discharge, at 30 days, 6 months, 12 months, and annually at 2, 3, 4, and 5 years postoperatively)
- Stent Migration Incidence Rate(pre-discharge, at 30 days, 6 months, 12 months, and annually at 2, 3, 4, and 5 years postoperatively)
- Endoleak Incidence Rate(pre-discharge, at 30 days, 6 months, 12 months, and annually at 2, 3, 4, and 5 years postoperatively)
- Maximum Diameter and Diameter Change of Aortic Lesion(pre-discharge, at 30 days, 6 months, 12 months, and annually at 2, 3, 4, and 5 years postoperatively)
- Aortic Lesion-related Mortality Rate(pre-discharge, at 30 days, 6 months, 12 months, and annually at 2, 3, 4, and 5 years postoperatively)
- Paraplegia Incidence Rate(pre-discharge, at 30 days, 6 months, 12 months, and annually at 2, 3, 4, and 5 years postoperatively)
- Stroke Incidence Rate(pre-discharge, at 30 days, 6 months, 12 months, and annually at 2, 3, 4, and 5 years postoperatively)