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

Phase

Condition

Aneurysm

Treatment

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

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).

Clinical Study ID

NCT06400940

D-ASIA

Ages > 18
All Genders

Study 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

Inclusion Criteria:

localization and structure of the aneurysm allows the use of a DERIVO®/DERIVO® miniflow-diverting stent for treatment;
the aneurysm cannot be cured by other methods of endovascular therapy, or there is ahigher risk of complications when using other methods of endovascular therapy ormicrosurgery;
clipping or embolization with spirals (if performed earlier) led to a recurrence ofthe aneurysm.

Exclusion

Exclusion Criteria:

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 medicaldevice, specified in the instructions for use:

non-compliance of the aneurysm and/or the carrier vessel with the indications forthe 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/oranticoagulant therapy in accordance with the instructions for the medical use ofdrugs.

Study Design

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

August 17, 2023

August 31, 2028

Study Description