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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
Details
| Lead sponsor | Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health |
|---|---|
| Phase | Phase 4 |
| Status | RECRUITING |
| Enrolment | 640 |
| Start date | 2023-08-17 |
| Completion | 2028-08 |
Conditions
- Intracranial Aneurysm
Interventions
- ticagrelor (tablets, 180 mg) or prasugrel (tablets, 10 mg).
- 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 outcomes
- 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.
Countries
Russia