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

NCT06400940 | Recruiting Phase 4

• 1 other identifier: D-ASIA
• Study Type: interventional
• Target: 640
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Intracranial Aneurysm

Outcome Measures

Primary Outcomes (1)

• Composite primary endpoint:

  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 Outcomes (3)

• Secondary endpoints:

  For all randomized participants up to 2 weeks

• Secondary endpoints:

  For all randomized participants up to 2 weeks

• Secondary endpoints:

  baseline/discharge

Other Outcomes (10)

• 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:

  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:

  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:

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

Study Arms (2)

Antiplatelet (antithrombotic) monotherapy

EXPERIMENTAL

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

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

Double antiplatelet (antithrombotic) therapy

ACTIVE COMPARATOR

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).

Interventions

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

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

Antiplatelet (antithrombotic) monotherapy

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).

Double antiplatelet (antithrombotic) therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

V.A. Almazov Fnmrc

Saint Petersburg, 197341, Russia

RECRUITING

MeSH Terms

Conditions

Intracranial Aneurysm

Interventions

Ticagrelor; Tablets; Prasugrel Hydrochloride; Aspirin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Dosage Forms; Pharmaceutical Preparations; Thiophenes; Sulfur Compounds; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Principal Investigator, Head of Neurosurgical Department

Model Details: Prospective, post-registration, interventional, randomized, in parallel groups,

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: May 6, 2024
• Study Start: August 17, 2023
• Primary Completion (Estimated): August 17, 2026
• Study Completion (Estimated): August 1, 2028
• Last Updated: May 6, 2024

Record last verified: 2024-05

Locations

RU (1)