Unruptured intracranial aneurysm
Conditions
Interventions
The study will be conducted following the CONSORT protocol for randomized clinical trials. One hundred and twenty patients with cerebral aneurysms requiring flow diversion treatment will be randomized
the centers will not be blinded to randomization, but the final data evaluator will be blinded and independent. For randomization, patients must meet all of the following inclusion and exclusion crite
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D27.505.954.502.780
Sponsors
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Eligibility
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Patients between 18 and 80 years old inclusive; Patients with an unruptured aneurysm of one of the following locations: internal carotid artery, middle cerebral artery, anterior cerebral artery, vertebral artery, basilar artery, posterior cerebral artery; Saccular aneurysm measuring = 3 mm in greatest diameter; Neck aneurysm measuring = 3 mm, or dome-neck ratio = 2; modified Rankin Scale (mRS) prior = 3; Patient agrees and signs the informed consent form
Exclusion criteria
Exclusion criteria: Any ischemic or hemorrhagic stroke within the last 90 days; Ruptured aneurysm in the last 90 days; Had major surgery that required general anesthesia in the last 90 days; Known clotting disorder; Use of anticoagulants; Platelet count 2.5 mg/dL; Pregnancy, lactation, positive pregnancy test; Modified Rankin scale previous from 4 or 5; Any other medical condition that results in a life expectancy = 12 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety of treating cerebral aneurysms with a p64-p48 HPC diverter (phenox, Bochum, Germany) by measuring the incidence of any serious neurological complication such as ischemic stroke or hemorrhagic stroke that lead to permanent neurological deficit or death after treatment and in the 1, 6 and 12 month follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the effectiveness of the treatment of intracranial aneurysms with a flow-diverter, measuring the rate of complete occlusion of the aneurysms after 6 and 12 months of treatment, using two regimens of antiplatelet aggregation: aspirin and prasugrel (double therapy) or prasugrel (monotherapy) | — |
Countries
Brazil
Contacts
Public ContactDaniel Abud
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Outcome results
None listed