An observational study in Intracranial Stenosis and Intracranial Atherosclerotic Disease, sponsored by Insel Gruppe AG, University Hospital Bern. Recruiting at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-18.
Sponsored by Insel Gruppe AG, University Hospital Bern · Observational
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.
Insel Gruppe AG, University Hospital Bern is the lead sponsor of 724 studies on the registry; 177 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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).
Time frame: at 3 months after endovascular treatment
Rate of technical success
Succesful versus failed recanalization; presence or absence of the residual stenosis
Time frame: on the day of procedure
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).
Time frame: through study completion, an average of 1 year
Death during the initial hospital stay
Time frame: 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
Time frame: from day 1 up to 3 months
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)
Time frame: from the day of treatment through study completion, an average of 6 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).
Time frame: from the endovascular treatment through study completion, an average of 6 months
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Insel Gruppe AG, University Hospital Bern