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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 640 participants in total. It began in 2023-08-17 with a primary completion date of 2026-08-17.
⚠ 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
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 contraindications for antiplatelet (antithrombotic) and/or anticoagulant therapy in accordance with the instructions for the medical use of drugs.
Frequently Asked Questions
Who can join the NCT06400940 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Intracranial Aneurysm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06400940 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06400940 currently recruiting?
Yes, NCT06400940 is actively recruiting participants. Visit ClinicalTrials.gov or contact Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health to inquire about joining.
Where is the NCT06400940 trial being conducted?
This trial is being conducted at Saint Petersburg, Russia.
Who is sponsoring the NCT06400940 clinical trial?
NCT06400940 is sponsored by Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health. The trial plans to enroll 640 participants.