Comparing the Efficacy and Safety of IBD Stent of Shenzhen Xianjian Company and IBE Stent of American Gore Company for Reconstruction of Internal Iliac Artery in Abdominal Aortic Aneurysm/Iliac Aneurysm Repair
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Primary patency
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of IBD stent of Shenzhen Xianjian Company and IBE stent of American Gore company in the treatment of abdominal aortic aneurysm/iliac aneurysm reconstruction of internal iliac artery
详细描述
This study is a prospective observational exploratory cohort study without a control group. As a single-group target value validation study, the main evaluation indicator is the primary patency rate one year after surgery. As an exploratory study, considering the enrollment ability to facilitate data analysis, 40 subjects are enrolled in the final study, and 20 are expected to be included in each study. All enrolled patients will be followed for 12 months for CTA to assess primary patency. Telephone follow-up was conducted at 1, 3, 6, and 12 months for adverse events.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with iliac aneurysms combined with or without abdominal aortic aneurysms and internal iliac arteries reconstructed with iliac branch stents;
- •Male or female ≥18 years old, ≤85 years old;
- •Life expectancy > 2 years;
- •The patient signed the informed consent voluntarily and was able to comply with the treatment plan and complete the follow-up and examination as planned.
排除标准
- •Fungal or ruptured aneurysm
- •Known complications of thoracic aortic aneurysm require interventional treatment
- •American Association of Anesthesiologists (ASA) Grade V
- •Creatinine > 2.5mg/dL or dialysis patients
- •NYHA Grade IV heart failure
- •Intercalation, severe calcification, or anchoring area with thrombosis
- •Severe curvature or narrowing of the iliac and/or femoral arteries, resulting in difficulty in stent delivery
- •Conduct another device or drug study within 1 year of treatment
- •Systemic infection
- •Combined with connective tissue disease
- •Known history of drug use
- •Known allergies or allergies to equipment materials
结局指标
主要结局
Primary patency
时间窗: 12-month
CTA showed patency of the preserved internal iliac artery.
次要结局
- Internal leakage(12-month)
- Secondary endovascular repair surgery(12-month)
- New hip lameness(12-month)
- Secondary patency(12-month)
- Aneurysm rupture(12-month)
- Aneurysmal enlargement(12-month)