RecruitingPhase 4NCT06400940

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

Sponsor

Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

Enrollment

640 participants

Start Date

Aug 17, 2023

Study Type

INTERVENTIONAL

Conditions

Intracranial Aneurysm

Summary

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

Eligibility

Min Age: 18 Years

Inclusion Criteria3

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 Criteria9

Age less than 18 years.
Pregnancy.
The presence of a previously implanted stent in a cerebral artery.
Dissection of cerebral or peripheral vessels.
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.
The presence of contraindications for antiplatelet (antithrombotic) and/or anticoagulant therapy in accordance with the instructions for the medical use of drugs.

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Interventions

DRUGticagrelor (tablets, 180 mg) or prasugrel (tablets, 10 mg).

Antiplatelet (antithrombotic) monotherapy, including ticagrelor (tablets, 180 mg) or prasugrel (tablets, 10 mg).

DRUGcombination of clopidogrel (tablets, 75 mg) and acetylsalicylic acid (ASA, tablets, 100 mg) or a combination of ticagrelor (tablets, 180 mg) and ASA (tablets, 100 mg).

Double antiplatelet (antithrombotic) therapy (DAT), including a combination of clopidogrel (tablets, 75 mg) and acetylsalicylic acid (ASA, tablets, 100 mg) or a combination of ticagrelor (tablets, 180 mg) and ASA (tablets, 100 mg).