Registry in Patients With Thoracoabdominal Aneurysms Treated With Multi-branch Stent Grafts Tailored to Their Individual Anatomies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- JOTEC GmbH
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Rate of patients with stable or decreasing aneurysm size at 12 months follow-up (measured by CoreLab)
研究概览
简要总结
In this study patients will be observed, who receive a multi-branch stent graft tailored to the patients anatomy for the endovascular treatment of a thoracoabdominal aortic aneurysm Crawford type I, II, III, IV or V.
The objective of this study is to evaluate clinical and technical success as well as safety and feasibility of the multi-branch stent graft Systems used in endovascular treatment of thoracoabdominal aortic aneurysms that cannot be treated with commercially available devices. Primary endpoint of this study is the rate of patients with stable or decreasing aneurysm size at 12 months follow-up.
详细描述
In this study patients will be observed, who receive a multi-branch stent graft tailored to the patient´s anatomy for the endovascular treatment of a thoracoabdominal aortic aneurysm Crawford type I, II, III, IV or V. Participating physicians will be asked to provide their observations collected during routine care for patients he/she had decided to treat with a multi-branch stent graft produced by JOTEC GmbH. Informed consent of the patients to allow the use of their clinical records for the purpose of this observational study will be obtained before data are being collected.
The period of data collection will be 36 months from the intervention for each patient. A risk based source data verification will be performed. CT angiograms will be evaluated by a CoreLab.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Patients must have a thoracoabdominal aneurysm type Crawford type I, II, III, IV, or V
- •Patients must have a suitable proximal landing area
- •Patients must have a suitable distal landing area in the abdominal aorta or the iliac arteries
- •Patients must have suitable access vessels
- •Patients must be available for the appropriate follow-up times for the duration of the study
- •Patients have signed the informed consent before intervention
排除标准
- •Patients with infectious aneurysm
- •Patients with inflammatory aneurysm
- •Patients with ruptured or symptomatic aneurysm
- •Patients with traumatic aneurysm
- •Patients with aortic dissection
- •Patients who have a congenital degenerative collagen disease or connective tissue disorder
- •Patients with thrombocytopenia
- •Patients with an eGFR < 45ml/min/1.73m2 before the intervention
- •Patients with untreated hyperthyroidism
- •Patients with malignancy needing chemotherapy or radiation
- •Patients that will be treated or are treated with iliac branch devices
- •Patients pre-treated with Nellix (Endologix) or Ovation (Endologix) or Altura (Lombard Medical) stent grafts
- •Patients who are enrolled in another clinical study
- •Patients with life expectancy of less than 36 months
结局指标
主要结局
Rate of patients with stable or decreasing aneurysm size at 12 months follow-up (measured by CoreLab)
时间窗: 12 months follow-up
Decreasing size: \>/= 5mm Increasing size: \</= 5mm compared to first post-operative CT angiogram
次要结局
- Rate of all cause mortality(intra-op, post-op until 36 months follow-up)
- Rate of patients with main adverse events (product-related, procedure-related, aneurysm-related)(post-op until 36 months follow-up)
- Rate of patients with endoleaks type Ia, Ib, II, III, IV, V and of unknown origin(post-op until 36 months follow-up)
- Rate of patients with primary / secondary patency of branch vessels(post-op until 36 months follow-up)
- Rate of patients with primary / secondary clinical success(post-op until 36 months follow-up)
- Rate of patients with multi-branch stent graft migration(post-op until 36 months follow-up)
- Rate of patients with stent graft infection(post-op until 36 months follow-up)
- Rate of patients with primary / secondary technical success(post-op until 36 months follow-up)
- Rate of reinterventions(post-op until 36 months follow-up)
- Rate of patients with loss of device integrity(post-op until 36 months follow-up)
- Rate of patients with aneurysm rupture(post-op until 36 months follow-up)
- Rate of interventions in peri-operative periods (all related interventions until index procedure)(intra-op)
- Rate of patients with removal or failure to implant the multi-branch stent graft(intra-op, post-op until 36 months follow-up)