Intracranial Aneurysm
Conditions
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
Interventions
DRUGticagrelor (tablets, 180 mg) or prasugrel (tablets, 10 mg).
Antiplatelet (antithrombotic) monotherapy, including ticagrelor (tablets, 180 mg) or prasugrel (tablets, 10 mg).
DRUGcombination 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).
Sponsors
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, post-registration, interventional, randomized, in parallel groups,
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Secondary endpoints: | 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; |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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). | * 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; |
| Clinical safety parameters: | 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; |
| Angiographic safety parameters based on Digital subtraction angiography (DSA) | 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. |
Countries
Russia
Outcome results
None listed