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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
640
Antiplatelet (antithrombotic) monotherapy, including ticagrelor (tablets, 180 mg) or prasugrel (tablets, 10 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).
V.A. Almazov Fnmrc
Saint Petersburg, Russia
RECRUITINGComposite 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.
Time frame: For all participants from date of randomization and on visit 3 (3-6 months) and visit 4 study completion (12-18 months).
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;
Time frame: For all randomized participants up to 2 weeks
Secondary endpoints:
● the average amount of time required to install a flow-diverting stent;
Time frame: 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.
Time frame: baseline/discharge
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