Endovascular Recanalization for Symptomatic Chronic Intradural Occlusions

NCT ID: NCT07072026

Last Updated: 2025-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-15

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Intracranial Stenosis Intracranial Atherosclerotic Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Alfried Krupp Krankenhaus

Essen, , Germany

Site Status RECRUITING

Inselspital Bern, University Hospital Bern

Bern, , Switzerland

Site Status RECRUITING

Countries

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Germany Switzerland

Central Contacts

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Petra Cimflova, MD, PhD

Role: CONTACT

+41316640831

Jan Gralla, Prof. Dr. med.

Role: CONTACT

+41316322654

Facility Contacts

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Fatima Quaiser

Role: primary

Petra Cimflova, MD, PhD

Role: primary

+41316640831

Other Identifiers

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2025-00410

Identifier Type: -

Identifier Source: org_study_id

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