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

RecruitingPhase 4Ages 18 Years - anyAllFederal State Budgetary Institution, V. A. Almazo…
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • 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).
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Where

1 site
V.A. Almazov Fnmrc
Saint Petersburg, Russia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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