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
