NCT06400940 Prospective, Post-registration, Interventional, Randomized, in Parallel Groups, Multicenter Eurasian Clinical Study of DERIVO®/DERIVO® Mini Aneurysm Embolization Device, Europe-Asia
| NCT ID | NCT06400940 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health |
| Condition | Intracranial Aneurysm |
| Study Type | INTERVENTIONAL |
| Enrollment | 640 participants |
| Start Date | 2023-08-17 |
| Primary Completion | 2026-08-17 |
Trial Parameters
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Brief Summary
Prospective, post-registration, interventional, randomized, in parallel groups, multicenter Eurasian clinical study of DERIVO®/DERIVO® mini Aneurysm Embolization Device, Europe-Asia
Eligibility Criteria
Inclusion Criteria: * localization and structure of the aneurysm allows the use of a DERIVO®/DERIVO® mini flow-diverting stent for treatment; * the aneurysm cannot be cured by other methods of endovascular therapy, or there is a higher risk of complications when using other methods of endovascular therapy or microsurgery; * clipping or embolization with spirals (if performed earlier) led to a recurrence of the aneurysm. Exclusion Criteria: 1. Age less than 18 years. 2. Pregnancy. 3. The presence of a previously implanted stent in a cerebral artery. 4. Dissection of cerebral or peripheral vessels. 5. The presence of contraindications to the use of the DERIVO®/DERIVO® mini medical device, specified in the instructions for use: * non-compliance of the aneurysm and/or the carrier vessel with the indications for the use of the device; * non-physiological structure of cerebral vessels; * vascular disorders that are a contraindication to endovascular interventions. 6. The presence of contrain