Fusion Imaging in Endovascular Thrombectomy for Acute Ischemic Stroke
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Region Skane
- Enrollment
- 300
- Locations
- 4
- Primary Endpoint
- Successful recanalization
Study Overview
Brief Summary
Endovascular thrombectomy (EVT) is the standard of care for acute ischemic stroke (AIS) caused by a large vessel occlusion.
Successful recanalization is one of the most important factors for a good patient outcome, especially when obtained within 30 minutes from groin puncture, and the procedural success-rate reaches above 90% at treating centers of excellence. There are however a portion of cases where recanalization is not achieved, which in some cases are attributed to difficult arterial anatomy affecting the ability to catheterize the precerebral target vessel.
In the latest angiography platforms, 3D reconstructions of the aortic, cervical and intracranial arteries from the preprocedural CT angiography can be fused with periprocedural 2D digital subtraction angiography and/or fluoroscopy images, so called 2D/3D Fusion imaging. The preparation steps can be done before patient arrival to the angiography suite and the image fusion can be done in less than a minute during patient preparation. Previous observational studies have shown that the use of fusion imaging during EVT procedures may decrease failed target vessel access and increase procedural success rate and first-pass recanalization rate, without prolonging the procedure.
The purpose of this study is to assess the use of fusion imaging in EVT procedures and its effect on target vessel access, recanalization success-rate and procedure times.
Detailed Description
Rationale for the study Successful recanalization is one of the most important factors for a good patient outcome, especially when obtained within 30 minutes from groin puncture, and the procedural success-rate reaches above 90% at treating centers of excellence. In a previously published observational study it was shown that systematic use of Fusion increased the success-rate from 82 to 100%, the first-pass recanalization rate from 49 to 72%, as well as reduced the procedure times.
Risks of study participation The use of Fusion does not require any additional procedure or radiation exposure. A potential risk is that the use of Fusion would prolong the procedure by adding Fusion at the start of the procedure, however in a recently published observational study it was shown that systematic use of Fusion instead reduced the procedure times.
Steps that have be taken to control or mitigate risks. To mitigate the risk that the use of Fusion will cause procedural delays all operators will be trained in using Fusion.
Benefit/risk ratio The use of Fusion has been associated with an increased success-rate from, an increased first-pass recanalization rate and reduced the procedure times. There are no known risks associated with the use of Fusion; therefore, the benefit/risk-ratio is favorable.
Study design This is a multinational, multicenter, prospective, randomized clinical trial.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥18 years.
- •Eligible for an EVT procedure
Exclusion Criteria
- •Previous inclusion in this study
- •No access to a preoperative CTA
Arms & Interventions
EVT without Fusion
Standard endovascular treatment
Intervention: Standard EVT without Fusion (Procedure)
EVT with Fusion
Standard endovascular thrombectomy with Fusion
Intervention: Standard endovascular thrombectomy with Fusion (Procedure)
Outcomes
Primary Outcomes
Successful recanalization
Time Frame: At the end of the EVT procedure
Defined as modified Treatment in Cerebral Infarction score (mTICI) 2b or better.
Secondary Outcomes
- Target vessel access(During the EVT procedure)
- Excellent recanalization(At the end of the procedure)
- First pass recanalization(At the end of the procedure)
- Time from groin puncture to precerebral target vessel access(During the procedure)
- Time from groin puncture to first pass with stent-retriever and/or direct aspiration.(During the procedure.)
- Time from groin puncture to recanalization(During the procedure.)
- Groin to first-pass recanalization within within 30 minutes(During the procedure.)
- Successful image fusion(During the procedure.)