LIQUID - Treatment of Dural Arteriovenous Fistulas With SQUID™ Liquid Embolic Agent, A Non-interventional, Observational, Prospective and Multi-center Study
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Dr. Markus Alfred Möhlenbruch
- Enrollment
- 50
- Locations
- 7
- Primary Endpoint
- Morbidity/Mortality
Overview
Brief Summary
The purpose of this study is assessment of safety, efficacy, and short-term outcome of SQUID™ in the embolization of Dural Arteriovenous Fistula
Detailed Description
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 .
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •DAVF with a Lariboisiere score \< 3 • Pregnancy
Outcomes
Primary Outcomes
Morbidity/Mortality
Time Frame: 90-180 days after treatment
number of patients with permanent morbidity or mortality
Occlusion rate
Time Frame: 90 -180 days after treatment
number of patients with complete occlusion of the treated Dural Arteriovenous Fistula
Secondary Outcomes
- 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)
Investigators
Dr. Markus Alfred Möhlenbruch
Principle Investigator
University Hospital Heidelberg