Observational, Prospective, Multicenter Study on HISTOACRYL® Used for Embolization of Thoracoabdominal Artery Bleeding (TAB)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Aesculap AG
- 入组人数
- 176
- 试验地点
- 11
- 主要终点
- Clinical Success at 1 Month After Histoacryl® Embolization
研究概览
简要总结
This observational study will collect information from adult patients in Japan who are treated with Histoacryl® to stop bleeding from arteries in the chest or abdomen, in order to better understand how well the treatment works and how safe it is during routine medical care.
详细描述
TAB includes arterial bleeding of various causes. Untreated bleeding can lead to hemorrhagic shock and organ failure. Transcatheterial arterial embolization is an established treatment option. NBCA is an effective liquid embolizing agent.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active thoracoabdominal arterial bleeding diagnosed by endoscopy, catheter angiography, or computed tomography angiography (CTA).
- •Planned embolization treatment using Histoacryl® as the sole embolic agent for the target lesion.
- •No endoleak following thoracic endovascular aortic repair (TEVAR) or endovascular abdominal aortic repair (EVAR).
- •Patients with malignant tumors must have an expected survival of at least 1 month.
- •Written informed consent obtained from the patient or a legally authorized representative.
排除标准
- •Previous embolization in the target vascular territory.
- •Known allergy or hypersensitivity to n-butyl cyanoacrylate (NBCA), Lipiodol®, or related treatment components.
- •Use of adjunctive embolic agents in the same target location.
- •Planned surgical treatment after embolization as part of a predefined two-step treatment strategy.
- •Severe septicemia.
- •Participation in another clinical trial.
- •Target vessels unsuitable for safe Histoacryl® injection.
- •Empiric embolization without identification of a target bleeding location.
- •Pregnancy, with the exception of patients treated for postpartum hemorrhage.
研究组 & 干预措施
Embolization
Patients, treated with Histoacryl® for embolization after bleeding
干预措施: Embolization therapy (Device)
结局指标
主要结局
Clinical Success at 1 Month After Histoacryl® Embolization
时间窗: 30 ± 10 days after index embolization procedure
Clinical success is defined as absence of bleeding from the target location after embolization with Histoacryl® without need for re-embolization or other re-interventions of the target lesion due to persistent or recurrent hemorrhage. Assessment performed on a per-patient basis.
次要结局
- Technical Success of Embolarization(Immediately after completion of the index procedure)
- Clinical Success at 7 Days(7 ± 2 days after embolarization)
- Clinical Success at 3 Months (Optional Follow-up)(90 ± 15 days after embolization)
- Successful Device Delivery(During the index embolization procedure)
- Immediate Clinical Improvement(Immediately after completion of embolization)
- Freedom From Serious Adverse Events (SAEs)(7 days, 30 days, and optional 90 days after embolization)
- Major Procedure-Related Complications(During the index procedure)
- Ischemic Complications at the Target Location(Index procedure through 90 days)
- Device-Related Serious Adverse Events(Index procedure through 90 days)
- All-Cause Mortality(Up to 90 days after embolization)
- Bleeding-Related Mortality(Up to 90 days after embolization)
- Surgical Conversion(During the index hospitalization)
- Length of Hospital Stay(From procedure date until hospital discharge (up to 30 days))
- Unplanned Rehospitalization(Up to 30 days after embolization)