Prevalence and Etiologies of Intracranial Stenosis in Patients With Antiphospholipid Syndrome
NCT05583305
Antiphospholipid Syndrome, Autoimmune Diseases
Hong Kong
View Trial DetailsNCT Number: NCT07072026
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Alfried Krupp Krankenhaus, Essen, Germany
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: at 3 months after endovascular treatment
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: on the day of procedure
Succesful versus failed recanalization; presence or absence of the residual stenosis
Time frame: through study completion, an average of 1 year
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: from day 1 until discharge from hospital, on average of 7 days
Time frame: from day 1 up to 3 months
occurence of death from day 1 up to 3 months
Time frame: from the day of treatment through study completion, an average of 6 months
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 endovascular treatment through study completion, an average of 6 months
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).
Contact information is provided by the study sponsor or research team.
Jan Gralla, Prof. Dr. med.
CONTACT
Petra Cimflova, MD, PhD
CONTACT
Insel Gruppe AG, University Hospital Bern
Other
Feasibility of Endovascular Recanalization for Symptomatic Chronic Intradural Large Vessel Occlusions - Re-CHILL Study
Acronym: Re-CHILL
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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