Evaluation of a new device for treating brain aneurysms

Prospective, Post-registration, Interventional, Randomized, in Parallel Groups, Multicenter Eurasian Clinical Study of DERIVO®/DERIVO® Mini Aneurysm Embolization Device, Europe-Asia

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: PHASE4
• Study type: Interventional
• Enrollment: 640 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health (other)
• Locations: 1 site (Saint Petersburg)
• Trial ID: NCT06400940 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults with specific types of intracranial aneurysms that cannot be treated by standard methods.

Not a fit: Patients under 18, pregnant women, or those with certain vascular conditions may not benefit from this study.

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 performed: Other studies have shown promise with similar embolization devices, indicating potential for success in this approach.

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.

Where this trial is running

Saint Petersburg

• V.A. Almazov Fnmrc — Saint Petersburg, Russia (RECRUITING)

Conditions: Intracranial Aneurysm