NCT06256757尚未招募不适用
Safety and Validity of Extracorporeal Fenestration and in Situ Fenestration in Patients With Aortic Disease Involving the Left Subclavian Artery
The Fourth Affiliated Hospital of Zhejiang University School of Medicine0 个研究点目标入组 170 人开始时间: 2024年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 170
- 主要终点
- all-cause mortality
研究概览
简要总结
This trial aims to demonstrate the safety and validity of extracorporeal fenestration and in situ fenestration in patients with aortic disease involving the left subclavian artery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •(All of the following criteria were met for enrolment):
- •Patients aged greater than 18 years old and less than 80 years old.
- •Patients diagnosed with thoracic aortic disease, including thoracic aortic dissection, thoracic aortic aneurysm, thoracic aortic ulcer and intramural hematoma.
- •Patients needed endovascular repair (TEVER).
- •Patients who needed complete coverage of the left subclavian artery (planned landing Zone was in Zone 2 of the aortic zone).
- •The proximal lesion involved the proximal aorta within 1.5cm of the posterior edge of the left subclavian artery (LSA) opening, but not the left common carotid artery (LCCA).
- •Suitable femoral artery, iliac artery and brachial artery access can be used for endovascular treatment.
- •The patients could understand the purpose of the study, volunteered to participate in the study, and informed consent was signed by the subjects themselves or their legal representatives.
- •Patients were willing to undergo follow-up evaluation as required by the study protocol.
- •The life expectancy of the patient is more than 12 months.
排除标准
- •(If any of the following criteria is met):
- •The lesion involved the proximal aorta of the LCCA opening (Zone 0 and Zone 1).
- •The patient has a definite connective tissue disease (e.g., Marfan syndrome).
- •The subjects had a history of previous thoracic endovascular aortic repair (TEVAR).
- •Patients who have had or may have had severe allergic reactions to contrast media (anaphylactic shock, exfoliative dermatitis, etc.).
- •Patients with contraindications to antiplatelet and anticoagulant drugs.
- •The patient's compliance was poor and the follow-up could not be expected on time.
- •Patients with acute systemic infection.
- •Patients cannot tolerate general anesthesia.
- •Patients judged by the investigator to be ineligible for endovascular treatment.
结局指标
主要结局
all-cause mortality
时间窗: 1 month postoperative
all-cause mortality
次要结局
- incidence of secondary intervention(postoperative (1, 6，12 months))
- immediate technical success rate(immediate postoperative)
- incidence of endoleak(postoperative (1, 6，12 months))
- incidence of major adverse events (MAE)(postoperative (1, 6，12 months))
- all-cause mortality(postoperative (6, 12 months))
研究者
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