The BEST study is an academically initiated, single-center, prospective, randomized controlled clinical trial investigating the potential advantages and disadvantages of using a guide catheter with or without a balloon in the interventional treatment of acute ischemic stroke. The study population consists of adult patients with acute ischemic stroke of the anterior circulation for whom interventional recanalization therapy via catheter is indicated following interdisciplinary consultation between the Department of Neurology and Neuroradiology at Heidelberg University Hospital. In addition to routine clinical treatment measures and data collection, patients will be interviewed by telephone after 90 days to assess their quality of life and level of independence using standardized scoring systems. All medical devices used or investigated in this study bear the CE mark (Conformité Européenne ) and will be used within their intended purpose. Study participants will not be subjected to any additional invasive or burdensome procedures beyond normal usage.
Are balloon guide catheters in endovascular stroke therapy of the anterior circulation superior? (BEST) Background Meta-analyses on the use of balloon-guided catheters (BGK) suggest a better technical and clinical outcome after endovascular stroke therapy (EST). However, no randomised controlled trials exist to support these results, yet. Study objective To investigate whether usage of BGK for EST of anterior circulation ischemic stroke due to large vessel occlusion results in improved degree of recanalization of the target vessel and the associated vascular territory. Study population N = 110 patients (55 per group, 1:1 randomisation) with acute ischemic stroke due to large vessel occlusion of the anterior circulation and intention to treatment with EST. Inclusion criteria 1. Patients with acute ischemic stroke due to large vessel occlusion of the anterior circulation (internal carotid artery-T, M1 (segment of the middle cerebral artery) or proximal M2 (M2 segment of the middle cerebral artery) occlusion) proven by either computed tomography (CT) or magentic resonance imaging (MRI) 2. Estimated time between stroke onset / last seen well and study procedure of \< 24 hours 3. No relevant pre-stroke functional disability (pre-morbid modified Rankin Sacle (mRS) of 0 - 3) 4. Neurological deficit with a National Instutute of Health Stroke Scale (NIHSS) of ≥ 4 and ≤ 25 5. Age ≥ 18 6. Alberta Stroke Program Early CT Score (ASPECTS) ≥ 6 on baseline non-contrast CT \< 4,5h after onset or CT perfusion / MRI \> 4,5h after onset Exclusion criteria 1. Pre-existing stenosis in the target vessel requiring stent therapy 2. Tandem occlusions of both cervical and intracranial vessels 3. Prior intracranial hemorrhage or signs of intracranial hemorrhage during procedure 4. Notably increased risk of intracranial hemorrhage 5. Excessive vascular tortuosity that will likely result in unstable access or inability to access the target vessel 6. Dissection of the extra- or intracranial cerebral arteries 7. Pregnant or breast-feeding women 8. Known severe illness with life expectancy less than 6 months 9. Participating in another clinical trial during the follow-up period that could confound the treatment or outcomes of this investigation Intervention EST is performed with usage of either i) a BGK (Stryker MERCI 9F, Stryker Flowgate2 8F) or ii) a standard guide catheter without balloon (Cordis Vista Brite Tip 8F) Study design Mono-centric, prospective, parallel-group, randomized controlled trial with blinded endpoint evaluation (PROBE design) Clinical Site Location Heidelberg University Hospital, Germany Endpoints Primary endpoint: Proportion of patients with successful technical recanalisation (expanded treatment in cerebral infarction (eTICI) score 2c/3) Secondary endpoint (selected): Clinical outcome after 90 days using the modified Rankin Scale (mRS); severity of stroke symptoms after 24h measured by National Institute of Health Stroke Scale (NIHSS); Infarct Growth between baseline and first follow-up MRI measured by volume of lesion on diffusion-weighted imaging; volume and number of peripheral emboli on follow-up MRI measured on diffusion-weighted imaging; safety endpoints. Participant duration 3 months Estimated Study duration 2-3 years
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
110
Mechanical thrombectomy is an endovascular treatment for acute ischemic stroke caused by a large-vessel occlusion. It involves advancing a catheter, with or without a balloon usually via the femoral or radial artery, to the occluded intracranial artery and mechanically removing the thrombus using a stent retriever, aspiration device, or a combination of both.
Thrombectomy of acute ischemic stroke using a guide catheter without balloon
University Hospital Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
Successful recanalisation
expanded treatment in cerebral ischemia (eTICI) Score ≥2c eTICI Grades: grade 0: no perfusion noted (0% reperfusion) grade 1: reduction in thrombus but without any resultant filling of distal arterial branches grade 2A: reperfusion of 1-49% of the territory grade 2B50: reperfusion of 50-66% of the territory grade 2B67: reperfusion of 67-89% of the territory grade 2C: extensive reperfusion of 90-99% of the territory grade 3: complete or full reperfusion (100% reperfusion)
Time frame: up to day 1
Modified Rankin Scale
The Modified Rankin Scale (mRS) is a 7-point ordinal scale used to measure the degree of disability or dependence in daily activities, most commonly after stroke. 0 - No symptoms. 1. \- No significant disability. Able to carry out all usual activities, despite some symptoms. 2. \- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. \- Moderate disability. Requires some help, but able to walk unassisted. 4. \- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. \- Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. \- Dead.
Time frame: Up to 90 days after treatment
24hr NIHSS
The NIH Stroke Scale (NIHSS) is a standardized clinical scoring system used to quantify neurological deficit in patients with acute stroke. It assesses level of consciousness, language, motor strength, sensory function, visual fields, coordination, and neglect. Scores range from 0 (no deficit) to 42 (severe stroke), with higher scores indicating greater neurological impairment. NIHSS is widely used to guide acute treatment decisions, assess stroke severity, and predict clinical outcomes.
Time frame: 24 Hours after treatment
7d NIHSS
The NIH Stroke Scale (NIHSS) is a standardized clinical scoring system used to quantify neurological deficit in patients with acute stroke. It assesses level of consciousness, language, motor strength, sensory function, visual fields, coordination, and neglect. Scores range from 0 (no deficit) to 42 (severe stroke), with higher scores indicating greater neurological impairment. NIHSS is widely used to guide acute treatment decisions, assess stroke severity, and predict clinical outcomes.
Time frame: Up tp Day 7 after treatment
Technical success
The expanded Thrombolysis in Cerebral Infarction (eTICI) score is an angiographic grading scale used to assess the degree of cerebral reperfusion after endovascular treatment in acute ischemic stroke. It ranges from 0 (no reperfusion) to 3 (complete reperfusion), with intermediate grades reflecting increasing levels of partial reperfusion. The eTICI score is commonly used to evaluate the technical success of mechanical thrombectomy, with eTICI 2b-3 generally considered successful reperfusion. eTICI Grades: grade 0: no perfusion noted (0% reperfusion) grade 1: reduction in thrombus but without any resultant filling of distal arterial branches grade 2A: reperfusion of 1-49% of the territory grade 2B50: reperfusion of 50-66% of the territory grade 2B67: reperfusion of 67-89% of the territory grade 2C: extensive reperfusion of 90-99% of the territory grade 3: complete or full reperfusion (100% reperfusion)
Time frame: Periprocedural
First-Pass-Effekt, Number of Participants with reperfusion on first pass
The First-Pass Effect (FPE) in mechanical thrombectomy describes the achievement of successful reperfusion after a single thrombectomy device pass, without the need for additional attempts. It is typically defined as eTICI 2c or 3 reperfusion on the first pass. The First-Pass Effect is clinically relevant because it is associated with shorter procedure times, less endothelial injury, fewer complications, and better functional outcomes compared with reperfusion requiring multiple passes.
Time frame: Periprocedural
Time to visualization
Time interval between the start of thrombectomy and visualization of the occlusion, in minutes
Time frame: Periprocedural
Time to first pass
Time interval between the start of thrombectomy and the first recanalization maneuver, in minutes
Time frame: Periprocedural
Time to success
Time interval between the start of thrombectomy and successful recanalization defined as eTICI 2c or 3 reperfusion, in minutes
Time frame: Periprocedural
Number of Passes
Number of passes / manouvers done required to achieve recanalization or unsuccessful termination of treatment determined by treating physician
Time frame: Periprocedural
Number of Participants with Distal emboli
Embolization in previously unaffected territories during thrombectomy
Time frame: Periprocedural
Infarct growth
Infarct growth between imaging before therapy and 24-48 hours after treatment
Time frame: up to 48 hours after treatment
Number of emboli
Number and volume of peripheral emboli (measured in diffusion-weighted imaging of the follow-up MRI examination)
Time frame: Day 1 - 2
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