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

May 2, 2024 updated by: Andrey Evgenievich Petrov, Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Prospective, post-registration, interventional, randomized, in parallel groups, multicenter Eurasian clinical study of DERIVO®/DERIVO® mini Aneurysm Embolization Device, Europe-Asia

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

640

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Antiplatelet (antithrombotic) monotherapy
Antiplatelet (antithrombotic) monotherapy, including ticagrelor (tablets, 180 mg) or prasugrel (tablets, 10 mg).
Drug: ticagrelor (tablets, 180 mg) or prasugrel (tablets, 10 mg).
Antiplatelet (antithrombotic) monotherapy, including ticagrelor (tablets, 180 mg) or prasugrel (tablets, 10 mg).
Active Comparator: Double antiplatelet (antithrombotic) therapy
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).
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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

Outcome Measure
Measure Description
Time Frame
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;
For all randomized participants up to 2 weeks
Secondary endpoints:
Time Frame: For all randomized participants up to 2 weeks
● the average amount of time required to install a flow-diverting stent;
For all randomized participants up to 2 weeks
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.
baseline/discharge

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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;
For all participants from date of randomization and on visit 3 (3-6 months) and visit 4 study completion (12-18 months).
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;
For all participants from date of randomization and on visit 3 (3-6 months) and visit 4 study completion (12-18 months).
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.
For all participants from date of randomization and on visit 3 (3-6 months) and visit 4 study completion (12-18 months).
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;
through study completion, an average of 1,5 year
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;
through study completion, an average of 1,5 year
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;
through study completion, an average of 1,5 year
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;
through study completion, an average of 1,5 year
Clinical safety parameters:
Time Frame: through study completion, an average of 1,5 year
● frequency of deaths;
through study completion, an average of 1,5 year
Clinical safety parameters:
Time Frame: through study completion, an average of 1,5 year
the frequency of other Adverse Events and Serious Adverse Events
through study completion, an average of 1,5 year
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.
through study completion, an average of 1,5 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 17, 2023

Primary Completion (Estimated)

August 17, 2026

Study Completion (Estimated)

August 1, 2028

Study Registration Dates

First Submitted

April 24, 2024

First Submitted That Met QC Criteria

May 2, 2024

First Posted (Actual)

May 6, 2024

Study Record Updates

Last Update Posted (Actual)

May 6, 2024

Last Update Submitted That Met QC Criteria

May 2, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D-ASIA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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