LIQUID - Treatment of Dural Arteriovenous Fistulas With SQUID™ Liquid Embolic Agent, A Non-interventional, Observational, Prospective and Multi-center Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 7
- 主要终点
- Morbidity/Mortality
研究概览
简要总结
The purpose of this study is assessment of safety, efficacy, and short-term outcome of SQUID™ in the embolization of Dural Arteriovenous Fistula
详细描述
Traditionally, there are two therapeutic options for the treatment of Dural Arteriovenous Fistula (DAVF): (1) the surgical approach consisting of craniotomy and ligation of the vein and (2) the endovascular approach with embolization of shunting zone. Onyx™ (EVOH (Ethylene Vinyl Alcohol) in solution in an organic solvent, DMSO (Dimethyl Sulfoxide), is the main embolic agent used for the endovascular treatment of DAVF. During the occlusion procedure with Onyx™, residual malformed compartments become gradually less visible on x-ray to the operator, due to the high radiopacity of Onyx™, resulting in a potential risk during treatment. Moreover, viscosity is frequently not as low as required to penetrate the shunt.Thus, development a new embolization system with lower radiopacity and lower viscosity to achieve improved occlusion is needed. SQUID™ is a new liquid embolic agent, with variable radiopacity and viscosity. The purpose of this study is assessment of safety, efficacy, and short-term outcome of SQUID™ in the embolization of DAVFs .
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
- •Dural Arteriovenous Fistula requiring endovascular treatment with a Lariboisiere score between 3 - 5
- •Intended usage of SQUID™
- •The patient agrees with the clinical data collection and medical file access.
排除标准
- •DAVF with a Lariboisiere score < 3 • Pregnancy
结局指标
主要结局
Morbidity/Mortality
时间窗: 90-180 days after treatment
number of patients with permanent morbidity or mortality
Occlusion rate
时间窗: 90 -180 days after treatment
number of patients with complete occlusion of the treated Dural Arteriovenous Fistula
次要结局
- Follow-Up Aneurysm Occlusion(90-180 days after treatment)
- Functional health status(90-180 days after treatment)
- Feeders(Treatment / day 1)
- DAVF anatomy(Baseline / day 0-1)
- modified Rankin Score(Baseline / day 0-1)
- Approach(Treatment / day 1)
- Volume of Squid(Treatment / day 1)
- Ballons(Treatment / day 1)
- Coils(Treatment / day 1)
- Other(Treatment / day 1)
- Immediate Aneurysm Occlusion(Treatment / Day 1)
研究者
Dr. Markus Alfred Möhlenbruch
Principle Investigator
University Hospital Heidelberg