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Recruiting NCT06400940

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

Phase IV Interventional Intracranial Aneurysm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 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)..
Who it may be relevant to
Registry conditions: Intracranial Aneurysm. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Russia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Detailed description

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

Interventions

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

Primary outcome measures

  • Composite primary endpoint: [Time frame: For all participants from date of randomization and on visit 3 (3-6 months) and visit 4 study completion (12-18 months).]
Secondary outcome measures (3)
  • Secondary endpoints: [Time frame: For all randomized participants up to 2 weeks]
  • Secondary endpoints: [Time frame: For all randomized participants up to 2 weeks]
  • Secondary endpoints: [Time frame: baseline/discharge]

Eligibility criteria

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

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Russia · 1 center
  • V.A. Almazov Fnmrc — Saint Petersburg

Identifiers

NCT: NCT06400940 · D-ASIA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗