Actively Recruiting

Age: 18Years +
All Genders
NCT07072026

Endovascular Recanalization for Symptomatic Chronic Intradural Occlusions

Led by Insel Gruppe AG, University Hospital Bern · Updated on 2025-07-18

80

Participants Needed

2

Research Sites

32 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Endovascular Recanalization for Symptomatic Chronic Intradural Occlusions

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients who underwent endovascular recanalization for chronic intradural large vessel occlusions between January 1, 2020, and December 31, 2024
  • Occlusions located in the internal carotid artery (ICA), middle cerebral artery (MCA), vertebral artery (VA), or basilar artery (BA)
Not Eligible

You will not qualify if you...

  • Patients who have given documented written or verbal refusal to participate

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Alfried Krupp Krankenhaus

Essen, Germany, 45131

Actively Recruiting

2

Inselspital Bern, University Hospital Bern

Bern, Switzerland, 3010

Actively Recruiting

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Research Team

P

Petra Cimflova, MD, PhD

CONTACT

J

Jan Gralla, Prof. Dr. med.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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