Clinical Trial

Endovascular Recanalization for Symptomatic Chronic Intradural Occlusions

Study acronym: Re-CHILL
Recruiting
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Record status
This record was last updated July 18, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
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.
Trial Details
NCT Number NCT07072026
Lead Sponsor Insel Gruppe AG, University Hospital Bern
Conditions Intracranial Stenosis, Intracranial Atherosclerotic Disease
Enrollment 80 participants
Start Date 2025-05-15
Primary Completion 2025-12-31 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-07-18