Acute Ischemic Stroke, Acute Ischemic Stroke AIS, Acute Ischemic Stroke Patients
Conditions
Keywords
mechanical thrombectomy, endovascular treatment, endovascular stroke therapy, balloon guide catheters
Brief summary
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.
Detailed description
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
Interventions
DEVICEBallon guide catheter
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.
DEVICEGuide catheter without balloon
Thrombectomy of acute ischemic stroke using a guide catheter without balloon
Sponsors
University Hospital Heidelberg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Mono-centric, prospective, parallel-group, randomized controlled trial with blinded endpoint evaluation (PROBE design)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with an acute ischemic stroke * Location of the primary occlusion in the anterior cerebral circulation * Pre-therapeutic modified Rankin Scale (mRS) score of ≤ 3. * Written informed consent from 1. the patient or 2. their legal representative/guardian or 3. patient enrollment by an independent physician and the principal investigator
Exclusion criteria
* Patients with contraindications to interventional therapy * Patients with acute intracranial hemorrhage * Pregnancy/Breastfeeding * Pre-therapeutic mRS \> 3 * National Institute of Health Stroke Scale (NIHSS) ≤ 4 * Patients detained in an institution by court or government order * Patients who require intubation for treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful recanalisation | up to day 1 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Rankin Scale | Up to 90 days after treatment | 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. |
| 24hr NIHSS | 24 Hours after treatment | 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. |
| 7d NIHSS | Up tp Day 7 after treatment | 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. |
| Technical success | Periprocedural | 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) |
| First-Pass-Effekt, Number of Participants with reperfusion on first pass | Periprocedural | 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 to visualization | Periprocedural | Time interval between the start of thrombectomy and visualization of the occlusion, in minutes |
| Time to first pass | Periprocedural | Time interval between the start of thrombectomy and the first recanalization maneuver, in minutes |
| Time to success | Periprocedural | Time interval between the start of thrombectomy and successful recanalization defined as eTICI 2c or 3 reperfusion, in minutes |
| Number of Passes | Periprocedural | Number of passes / manouvers done required to achieve recanalization or unsuccessful termination of treatment determined by treating physician |
| Number of Participants with Distal emboli | Periprocedural | Embolization in previously unaffected territories during thrombectomy |
| Infarct growth | up to 48 hours after treatment | Infarct growth between imaging before therapy and 24-48 hours after treatment |
| Number of emboli | Day 1 - 2 | Number and volume of peripheral emboli (measured in diffusion-weighted imaging of the follow-up MRI examination) |
Countries
Germany
Contacts
PRINCIPAL_INVESTIGATORMichael O Breckwoldt, MD, PhD
University Hospital Heidelberg
STUDY_DIRECTORMarkus Möhlenbruch, MD, PhD
University Hospital Heidelberg
Outcome results
None listed