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NCT Number: NCT07072026

Endovascular Recanalization for Symptomatic Chronic Intradural Occlusions

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Alfried Krupp Krankenhaus, Essen, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Clinical outcome assesed by modified Rankin Scale

    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).

  2. Rate of technical success

    Time frame: on the day of procedure

    Succesful versus failed recanalization; presence or absence of the residual stenosis

Secondary outcomes

  1. Clinical outcome at the last available follow-up assesssed by modified Rankin Score

    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).

  2. Death during the initial hospital stay

    Time frame: from day 1 until discharge from hospital, on average of 7 days

  3. Death at 3 months

    Time frame: from day 1 up to 3 months

    occurence of death from day 1 up to 3 months

Other outcomes

  1. New Ischemic stroke on the follow-up imaging

    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)

  2. Rate of periprocedural and postprocedutral complications

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Jan Gralla, Prof. Dr. med.

CONTACT

[email protected]

+41316322654

Petra Cimflova, MD, PhD

CONTACT

[email protected]

+41316640831

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

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

Acronym: Re-CHILL

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 18, 2025
Registry last updated
Jul 18, 2025

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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