Prospective, Post-registration, Interventional, Randomized, in Parallel Groups, Multicenter Eurasian Clinical Study of DERIVO®/DERIVO® Mini Aneurysm Embolization Device, Europe-Asia
- Conditions
- Intracranial Aneurysm
- Interventions
- Registration Number
- NCT06400940
- Lead Sponsor
- Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
- Brief Summary
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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 640
- 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.
-
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Antiplatelet (antithrombotic) monotherapy ticagrelor (tablets, 180 mg) or prasugrel (tablets, 10 mg). Antiplatelet (antithrombotic) monotherapy, including ticagrelor (tablets, 180 mg) or prasugrel (tablets, 10 mg). Double antiplatelet (antithrombotic) therapy 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
Name Time Method Composite primary endpoint: 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 Outcome Measures
Name Time Method Secondary endpoints: 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.
Trial Locations
- Locations (1)
V.A. Almazov Fnmrc
🇷🇺Saint-petersburg, Russian Federation