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

Overview

Prospective, post-registration, interventional, randomized, in parallel groups, multicenter Eurasian clinical study of DERIVO®/DERIVO® mini Aneurysm Embolization Device, Europe-Asia

Description

Prospective, post-registration, interventional, randomized, in parallel groups, multicenter Eurasian clinical study of DERIVO®/DERIVO® mini Aneurysm Embolization Device, Europe-Asia

Eligibility

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.