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Recruiting NCT07072026

Endovascular Recanalization for Symptomatic Chronic Intradural Occlusions

Observational Intracranial Stenosis Intracranial Atherosclerotic Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Intracranial Stenosis, Intracranial Atherosclerotic Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany, Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Feasibility of Endovascular Recanalization for Symptomatic Chronic Intradural Large Vessel Occlusions - Re-CHILL Study

Overview

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.

Primary outcome measures

  • Clinical outcome assesed by modified Rankin Scale [Time frame: at 3 months after endovascular treatment]
  • Rate of technical success [Time frame: on the day of procedure]
Secondary outcome measures (3)
  • Clinical outcome at the last available follow-up assesssed by modified Rankin Score [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 [Time frame: from day 1 up to 3 months]

Eligibility criteria

Inclusion criteria

  • all consecutive patients who undergone endovascular recanalization for chronic intradural large vessel occlusions between January 1st, 2020, and December 31st, 2024 involving the following locations: internal carotid artery (ICA), middle cerebral artery (MCA), vertebral artery (VA), and basilar artery (BA)

Exclusion criteria

  • presence of documented written or verbal refusal

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 1 center
  • Alfried Krupp Krankenhaus — Essen
Switzerland · 1 center
  • Inselspital Bern, University Hospital Bern — Bern

Identifiers

NCT: NCT07072026 · 2025-00410

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗