NCT07072026 Endovascular Recanalization for Symptomatic Chronic Intradural Occlusions
| NCT ID | NCT07072026 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Insel Gruppe AG, University Hospital Bern |
| Condition | Intracranial Stenosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-05-15 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2025-05-15 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07072026 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Intracranial Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07072026 currently recruiting?
Yes, NCT07072026 is actively recruiting participants. Contact the research team at petra.cimflova@insel.ch for enrollment information.
Where is the NCT07072026 trial being conducted?
This trial is being conducted at Essen, Germany, Bern, Switzerland.
Who is sponsoring the NCT07072026 clinical trial?
NCT07072026 is sponsored by Insel Gruppe AG, University Hospital Bern. The trial plans to enroll 80 participants.