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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antiplatelet (antithrombotic) monotherapy | Experimental | Antiplatelet (antithrombotic) monotherapy, including 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ticagrelor (tablets, 180 mg) or prasugrel (tablets, 10 mg). | Drug | Antiplatelet (antithrombotic) monotherapy, including ticagrelor (tablets, 180 mg) or prasugrel (tablets, 10 mg). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary endpoints: | ● 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: |
| 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: |
|
Inclusion Criteria:
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:
The presence of contraindications for antiplatelet (antithrombotic) and/or anticoagulant therapy in accordance with the instructions for the medical use of drugs.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| V.A. Almazov Fnmrc | Recruiting | Saint Petersburg | 197341 | Russia |
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Prospective, post-registration, interventional, randomized, in parallel groups,
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| 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). |
|
● the average amount of time required to install a flow-diverting stent; |
| For all randomized participants up to 2 weeks |
| Secondary endpoints: | ● 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 |
| 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: | ● 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: | ● 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: | ● 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: | ● 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: | ● the frequency of bleeding and other AE caused by concomitant antithrombotic therapy; | through study completion, an average of 1,5 year |
| Clinical safety parameters: | ● 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: | ● frequency of deaths; | through study completion, an average of 1,5 year |
| Clinical safety parameters: | 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) | ● 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 |
| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077486 | Ticagrelor |
| D013607 | Tablets |
| D000068799 | Prasugrel Hydrochloride |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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