NCT05364502进行中（未招募）不适用
A Prospective Multicenter Single-Arm Staged Study to Evaluate the Safety and Effectiveness of Embrace™ Hydrogel Embolic For Transcatheter Embolization of Arterial Bleeding in Solid Organs and Peripheral Arteries
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 130
- 试验地点
- 44
- 主要终点
- Primary safety endpoint
研究概览
简要总结
To evaluate the safety and effectiveness of Embrace Hydrogel Embolic System for the transcatheter embolization of peripheral arterial bleeds.
详细描述
A Prospective Multicenter Single-Arm Staged Study to Evaluate the Safety and Effectiveness of Embrace™ Hydrogel Embolic For Transcatheter Embolization of Arterial Bleeding in Solid Organs and Peripheral Arteries
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Male or female patients age ≥ 18 years old
- •Subjects who are candidates for transarterial catheter embolization with arterial bleeding documented on a suitable radiologic imaging and/or endoscopic visualization study taken during the index hospitalization that allows for the source of the arterial injury/bleeding to be localized. Includes (but not limited to) the following:
- •Non-variceal Upper Gastrointestinal (UGI) bleeds refractory to endoscopic treatment
- •End organ/visceral bleeds (kidney, liver and spleen including tumor bleeds)
- •Spontaneous hematoma (e.g., rectus sheath and psoas muscle hematomas)
- •Other peripheral arterial bleeds (e.g., pelvic hemorrhage) if not associated with risk of ischemia distal to the lesion or embolization of non-expendable arteries.
- •Subjects with at least one target vessel ≤6mm and Embrace HES can be delivered to the target vessel(s).
- •Subject is willing to comply with follow-up evaluation schedule.
- •No prior embolization in the target territory prior to study entry
- •The subject or a legally authorized representative has provided informed consent approved by the appropriate local IRB/EC.
排除标准
- •Life expectancy ≤ 30 days
- •In the Investigator's opinion, due to injury severity the subject is not likely to benefit from angioembolization (e.g., in the presence of significant polytrauma, multiple organ failure or shattered organs).
- •Any contraindication to arteriography or the embolization protocol utilized at treating institution.
- •Pregnant or breast-feeding (women of child-bearing potential must undergo a pregnancy test performed in accordance with local institutional requirements and agree to use contraception for at least six months).
- •Hemorrhagic shock (Class IV-see Appendix 1) at time of treatment
- •Target vascular territory supplied by the pulmonary artery, coronary artery, or cerebral or cerebellar artery (requiring embolization of these arteries) or the artery to be embolized has connections to these arteries via a collateral pathway.
- •Embolization for treatment of spinal arteries, lower GI bleeds, arteriovenous malformations, embolization of arteriovenous shunts, endoleak management, neurovascular bleeds, penetrating trauma of extremities.
- •Forrest Classification Type III UGI bleeds (see Appendix 2)
- •In the investigator's opinion, patient will require embolization of 4 or more discrete vascular territories/arterial injuries (requires that microcatheter be repositioned to discrete area) based on diagnostic angiography or another suitable imaging study.
- •Known or suspected angio-anatomical conditions that in the Investigator's opinion, would prevent the delivery catheter to gain access to the selected position for safe and intended embolization.
- •Known allergies (based on history) to PEG, ferrous compounds, tert Butyl Hydroperoxide, contrast media or procedural sedatives/anesthetics that is not amenable to pre-medication
- •Presence of medically relevant localized or systemic infection
- •The patient has other concurrent conditions or known history that in the opinion of the Investigator would be unlikely to receive clinical benefit from the study procedure or participation in the study may compromise patient safety or study objectives (including but not limited to ongoing acute infection, life-threatening concomitant trauma or conditions).
- •Presence of Uncorrectable Coagulopathy: Defined as thrombocytopenia with platelet counts < 40,000/mm3 and/or INR > 2.
- •If known, enrollment in a concurrent study in which the study treatment may confound the evaluation of the study device.
结局指标
主要结局
Primary safety endpoint
时间窗: Through 30 days post-index procedure
Freedom from major adverse events (MAE)
Clinical Success
时间窗: Within 30 days of the index procedure
Defined as the absence of bleeding from the target lesion after embolization with Embrace HES without the need for subsequent embolic devices in the index procedure, emergency surgery, re-embolization or other target vessel re-interventions due to rebleeding.
Technical Success
时间窗: Immediately following index procedure
Defined as occlusion of the target vessel or exclusion of the area of arterial damage and/or the cessation of extravasation on angiography after embolization with Embrace HES.
次要结局
未报告次要终点
研究者
研究点 (44)
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