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NCT Number: NCT06400940

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

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

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Key information

Conditions

Intracranial Aneurysm Aneurysm Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Intracranial Arterial Diseases Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

Antiplatelet (antithrombotic) monotherapy, including 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).

Drug

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 outcomes

  1. 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).

    The proportion of favorable clinical outcomes corresponding to 0-2 points on the modified Rankin Scale (mRS) for assessing clinical status in the medium-term (3-6 months) and long-term (12-18 months) postoperative period.

Secondary outcomes

  1. Secondary endpoints:

    Time frame: For all randomized participants up to 2 weeks

    ● the proportion of technically successful stent implantations in the optimal position relative to the total number of treatment attempts using flow-diverting stents;

  2. Secondary endpoints:

    Time frame: For all randomized participants up to 2 weeks

    ● the average amount of time required to install a flow-diverting stent;

  3. Secondary endpoints:

    Time frame: baseline/discharge

    ● the change in the clinical status on the modified Rankin Scale (mRS) scale (0(no symptoms)-6 (death)) at the time of discharge compared with the value of the indicator at the screening.

Other outcomes

  1. The technical success of stent implantation will be evaluated based on Digital subtraction angiography (DSA) on the fit of the flow-diverting stent to the wall of the carrier vessel according to the following criteria:

    Time frame: For all participants from date of randomization and on visit 3 (3-6 months) and visit 4 study completion (12-18 months).

    • proper fit of the device for deflecting the flow to the walls in the carrier vessel;
    • the gap between the flow deflection device and the vessel wall is < 25% of the vessel diameter;
    • the gap between the flow deflection device and the vessel wall is > 25% of the vessel diameter.
    • proper fit of the device for deflecting the flow to the walls in the carrier vessel;
    • the gap between the flow deflection device and the vessel wall is < 25% of the vessel diameter;
    • the gap between the flow deflection device and the vessel wall is > 25% of the vessel diameter.
    • proper fit of the device for deflecting the flow to the walls in the carrier vessel;

  2. The technical success of stent implantation will be evaluated based on Digital subtraction angiography (DSA) on the fit of the flow-diverting stent to the wall of the carrier vessel according to the following criteria:

    Time frame: For all participants from date of randomization and on visit 3 (3-6 months) and visit 4 study completion (12-18 months).

    ● the gap between the flow deflection device and the vessel wall is < 25% of the vessel diameter;

  3. The technical success of stent implantation will be evaluated based on Digital subtraction angiography (DSA) on the fit of the flow-diverting stent to the wall of the carrier vessel according to the following criteria:

    Time frame: For all participants from date of randomization and on visit 3 (3-6 months) and visit 4 study completion (12-18 months).

    ● the gap between the flow deflection device and the vessel wall is > 25% of the vessel diameter.

  4. Clinical safety parameters:

    Time frame: through study completion, an average of 1,5 year

    ● the frequency of sensitivity to Double antiplatelet (antithrombotic) therapy or antiplatelet (antithrombotic) monotherapy according to the data of analyzer VerifyNow platelet testing and LTA platelet testing in patients of Mongoloid or Caucasoid races;

  5. Clinical safety parameters:

    Time frame: through study completion, an average of 1,5 year

    ● the frequency of neurological disorders immediately after implantation of a flow- diverting stent;

  6. Clinical safety parameters:

    Time frame: through study completion, an average of 1,5 year

    ● the frequency of bleeding and other AE caused by concomitant antithrombotic therapy;

  7. Clinical safety parameters:

    Time frame: through study completion, an average of 1,5 year

    ● the frequency of acute cerebral circulation disorders in the medium-term (3-6 months) and long-term (12-18 months) postoperative period;

  8. Clinical safety parameters:

    Time frame: through study completion, an average of 1,5 year

    ● frequency of deaths;

  9. Clinical safety parameters:

    Time frame: through study completion, an average of 1,5 year

    the frequency of other Adverse Events and Serious Adverse Events

  10. Angiographic safety parameters based on Digital subtraction angiography (DSA)

    Time frame: through study completion, an average of 1,5 year

    ● the frequency of complications associated with the intervention - stent opening, stent apposition to the vessel wall, thrombosis, thromboembolism, blockage of vascular branches affected by aneurysm.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2028
First posted
May 6, 2024
Registry last updated
May 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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