Evaluation of a new device for treating brain aneurysms
Official title: Prospective, Post-registration, Interventional, Randomized, in Parallel Groups, Multicenter Eurasian Clinical Study of DERIVO®/DERIVO® Mini Aneurysm Embolization Device, Europe-Asia
Run by Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health · NCT06400940 · Data updated 2026-11-12
This study is testing a new device to treat brain aneurysms in patients who can't use other treatments or have had their aneurysms come back.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 640 (estimated) |
| Sponsor | Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health Academic / other |
| Locations | 1 site (Saint Petersburg) |
| Status | Recruiting |
| Started | August 17, 2023 |
| Main results expected | August 17, 2026 |
| Study ends | August 2028 |
| Registry record updated | May 6, 2024 |
| Trial ID | NCT06400940 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with specific types of intracranial aneurysms that cannot be treated by standard methods.
✕Probably not a fit
Patients under 18, pregnant women, or those with certain vascular conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial is a multicenter, randomized study that evaluates the effectiveness of the DERIVO®/DERIVO® mini Aneurysm Embolization Device for treating intracranial aneurysms. Participants will be assigned to receive either ticagrelor or prasugrel, or a combination of clopidogrel and acetylsalicylic acid, to assess the safety and efficacy of the device. The study aims to include patients whose aneurysms are not amenable to other treatment methods or have recurred after previous interventions. The trial is conducted across multiple centers in Europe and Asia.
Why it matters
Potential benefit: If successful, this study could provide a new, effective treatment option for patients with challenging intracranial aneurysms.
How similar studies have gone: Other studies have shown promise with similar embolization devices, indicating potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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V.A. Almazov Fnmrc
Saint Petersburg, Russia Recruiting
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Flow Diverter Stent for Intracranial Aneurysm in China
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This study tests whether the Silk Vista Baby flow diverter can safely and effectively treat a single unruptured intracranial aneurysm in adults 22–80 years old.
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Pipeline Vantage post-approval safety and outcomes for intracranial aneurysm treatment
This project will test whether the Pipeline Vantage embolization device with Shield Technology is safe and effective for adults treated for intracranial aneurysms.
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Improving brain intervention planning using vascular mapping
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.