NCT03707743进行中（未招募）不适用
A Physician-initiated, International, Multi-center, Prospective and Retrospective, Non Randomized, Observational Registry of Patients With Acute/Subacute Type B Aortic Dissection Treated by Means of the STABILISE Technique.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 34
- 主要终点
- Technical success of the STABILISE procedure
研究概览
简要总结
The aim of the study is to evaluate results of patients treated with the STABILISE technique for acute/subacute aortic dissection. Results and postoperative events are reported in accordance with the current reporting standards for endovascular aortic repair prepared and revised by the Ad Hoc Committee for Standardized Reporting Practices in Vascular Surgery of The Society for Vascular Surgery/American Association for Vascular Surgery
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Patients with ≥ 18 years of age;
- •Patients presenting with an acute (up to two weeks from the onset) and subacute (between 3 and 12 weeks from the onset) type B dissection with a proximal suitable non-dissected landing zone in the aortic arch or descending thoracic aorta (supra-aortic trunks debranching may be employed to obtain an adequate proximal landing zone);
- •Total aortic diameter of the abdominal aorta (from supra-celiac to infra-renal level) must not exceed 42 mm;
- •Patients able to sign specific informed consent for the study.
排除标准
- •Patients with chronic type B aortic dissection (more than 12 weeks from the onset);
- •Patients with acute type B aortic dissection not treated according to the following treatment protocol;
- •Unwilling or unable to comply with the follow-up schedule;
- •Inability or refusal to give informed consent;
- •Simultaneously participating in another investigative device or drug study;
- •Frank rupture;
- •Systemic infection (eg, sepsis);
- •Allergy to stainless steel, polyester, solder (tin, silver), polypropylene, nitinol, or gold;
- •Untreatable reaction to contrast, which, in the opinion of the investigator, cannot be adequately premedicated;
- •Surgical or endovascular AAA repair within 30 days before or after dissection repair;
- •Previous placement of a thoracic endovascular graft;
- •Prior open repair involving the descending thoracic aorta, including the supra-renal aorta and/or arch;
- •Interventional and/or open surgical procedures (unrelated to dissection) within 30 days before or after dissection repair.
结局指标
主要结局
Technical success of the STABILISE procedure
时间窗: 30 day
patency of visceral vessels and iliac arteries
Clinical success
时间窗: 30 day
absence of major adverse events (mortality, neurological complications, cardiological complications, respiratory complications, intestinal ischemia
次要结局
未报告次要终点
研究者
研究点 (34)
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