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

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

Status and phase: Enrolling; Phase 4

Conditions: Intracranial Aneurysm

Treatments: Drug: ticagrelor (tablets, 180 mg) or prasugrel (tablets, 10 mg).; Drug: 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).

Study type: Interventional

Funder types: Other

Identifiers

NCT06400940

D-ASIA

Details and patient eligibility

About

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

Full description

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

Enrollment: 640 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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640 participants in 2 patient groups

Antiplatelet (antithrombotic) monotherapy

Experimental group

Description:

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

Treatment:

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

Double antiplatelet (antithrombotic) therapy

Active Comparator group

Description:

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).

Treatment:

Drug: 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).