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Background: Chronic intracranial large vessel occlusion (LVO), resulting from progressive atherosclerosis or thrombosis, contributes significantly to ischemic strokes, 8-10% in North America and up to 50% in the Chinese population. This condition leads to cerebral hypoperfusion, brain ischemia, and potentially cognitive impairment. While extra-to-intracranial bypass surgery has shown limited benefit, recent advances in endovascular treatment (EVT) for acute ischemic stroke show promise. Preliminary reports suggest EVT may be feasible for chronic intracranial artery occlusions. Still, outcomes vary and perioperative risks remain high, particularly for intradural occlusions, which are technically more challenging and less studied.
Objectives: This study aims to evaluate the feasibility, safety, and clinical outcomes of EVT for symptomatic chronic intradural large vessel occlusions. Primary endpoints include technical success, complication rates, and functional outcomes, as measured by the modified Rankin Scale (mRS) at 3 months and the last follow-up. Safety endpoints include mortality, ischemic stroke, and periprocedural complications.
Design: A multicenter, retrospective and prospective observational study involving 10-20 experienced centers worldwide. Data from approximately 40-80 patients treated between January 2020 and December 2024 will be collected by local neuroradiologists, neurologists, or neurosurgeons. Clinical data (demographics, comorbidities, symptoms, outcomes), imaging data (pre-, post-, and follow-up), procedural details, and medication regimens will be collected. Inclusion criteria target adult patients with symptomatic chronic intradural occlusions of key intracranial arteries (ICA, MCA, VA, BA). Symptomatic occlusion is defined by neurological deficits or imaging evidence of ischemia. The data analysis will be performed by the local team at the Inselspital, Bern, Switzerland.
Aim: To descriptively analyze patient characteristics, treatment approaches, complications, and hemodynamic changes post-EVT to inform future therapeutic strategies for this challenging condition.
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| Measure | Description | Time Frame |
|---|---|---|
| Clinical outcome assesed by modified Rankin Scale | The primary outcome is the degree of dependency and disability in everyday life measured with the modified Rankin Score (mRS) at 90 days. The mRS is the standard tool to assess neurological outcome in trials with acute severe brain disease. The scale runs from 0-6, running from perfect health without symptoms (= 0) to death (= 6). | at 3 months after endovascular treatment |
| Rate of technical success | Succesful versus failed recanalization; presence or absence of the residual stenosis | on the day of procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical outcome at the last available follow-up assesssed by modified Rankin Score | Degree of dependency and disability in everyday life measured with the modified Rankin Score (mRS) . The mRS is the standard tool to assess neurological outcome in trials with acute severe brain disease. The scale runs from 0-6, running from perfect health without symptoms (= 0) to death (= 6). | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| New Ischemic stroke on the follow-up imaging | Radiologic occurrence of newly evolved ischemic stroke (hypodenisty or parenchymal defect on computer tomographie scan, or hyperintense lesion on T2 weighted/fluid-attenuated inversion recovery scan with or without corresponding restricted diffusion) | from the day of treatment through study completion, an average of 6 months |
Inclusion Criteria:
Exclusion Criteria:
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The intradural occlusion is defined as the occlusion entirely located or extended into an intradural vascular segment (e.g., ICA occlusion extending from the extradural ICA to the ophthalmic ICA segment).
The ICA segments are defined as follows:
The symptomatic occlusion is defined as acute neurological impairment and/or acute ischemic stroke or hypoperfusion within the affected vascular territory detected on baseline imaging.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Petra Cimflova, MD, PhD | Contact | +41316640831 | petra.cimflova@insel.ch | |
| Jan Gralla, Prof. Dr. med. | Contact | +41316322654 | jan.gralla@insel.ch |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alfried Krupp Krankenhaus | Recruiting | Essen | 45131 | Germany |
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| Death during the initial hospital stay | from day 1 until discharge from hospital, on average of 7 days |
| Death at 3 months | occurence of death from day 1 up to 3 months | from day 1 up to 3 months |
| Rate of periprocedural and postprocedutral complications | Any periprocedura complications including vessel perforation, acute in-stent thrombosis, distal thromboembolisation, complication in the access site (hematoma in situ, retroperitoneal hematoma, pseudoaneurysma, etc.). Detection of asymptomatic or symptomatic in-stent thrombosis or in-stent stenosis on follow-up angiography scan (computer tomographie angiography, magnetic resonance angiography, or digital subtraction angiography). | from the endovascular treatment through study completion, an average of 6 months |
| Inselspital Bern, University Hospital Bern | Recruiting | Bern | 3010 | Switzerland |
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