Intracranial aneurysms
Conditions
Interventions
550 units. If the ARU value is >
This is a prospective, consecutive, non-randomized clinical study including 100 patients divided in two groups of 50 patients with intracranial aneurysms treated with the Derivo-2heal flow-modulating
75 years, body weight <
60 kg, or prior ischemic or hemorrhagic stroke (>
3 months). Note (loading doses): At least 2 hours before the procedure, the following loading doses may be given: acetylsalicylic acid (ASA) 300 mg (3 tablets) and prasugrel 20 mg (2 tablets). Group 2
550 units, the patient will receive an additional 500 mg ASA loading dose, and the test will be repeated after 2 hours. For prasugrel, the PRU test will be used, with a target range of 60–180 units. P
180 will receive a 20 mg prasugrel loading dose, and the test will be repeated after 2 hours. Patients with PRU <
60 will have the prasugrel dose reduced to 5 mg/day. Follow-up antiplatelet therapy. Aspirin 100 mg once daily continuously. Prasugrel 10 mg once daily for 6 months, followed by aspirin 100 mg/day the
Sponsors
Fundação de Apoio ao Ensino, Pesquisa e Assistência do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Fundação de Apoio ao Ensino, Pesquisa e Assistência do 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 aged 18 to 80 years inclusive; Patients of any gender; Patients with an unruptured aneurysm; Saccular or fusiform aneurysm located in the right internal carotid artery; Patients who agree to and sign the informed consent form; Patient correctly using antiplatelet therapy
Exclusion criteria
Exclusion criteria: Any ischemic or hemorrhagic stroke within the past 90 days; Ruptured aneurysm within the past 90 days; Previous modified Rankin Scale (mRS) > 2; Major surgery requiring general anesthesia within the past 90 days; Known coagulation disorder; Use of anticoagulants (warfarin, dabigatran, etc.); Platelet count < 100,000 cells/mm³ or known platelet dysfunction; Contraindication to the study medications (heparin, aspirin, prasugrel); Presence of a previously placed neurostent adjacent to the aneurysm to be treated; Presence of a previously placed surgical clip adjacent to the aneurysm to be treated, causing any degree of carotid artery stenosis; Known severe allergy to iodinated contrast agents (defined by prior occurrence of bronchospasm, laryngospasm, or circulatory shock); Chronic kidney disease (defined by serum creatinine > 2.5 mg/dL); Pregnancy, breastfeeding, or a positive pregnancy test; Any other medical condition resulting in a life expectancy of = 12 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of the flow-modulating neurostent in the treatment of cerebral aneurysms by measuring the rate of complete aneurysm occlusion at 1, 6, and 12 months after treatment. ;To assess the safety of treating cerebral aneurysms with the Derivo-2 flow diverter (Accandis) by measuring the incidence of any serious neurological complications, such as ischemic or hemorrhagic stroke leading to permanent neurological deficit (defined as an increase of at least 1 point on the modified Rankin Scale) or death, during hospitalization and at 1, 6, and 12-month follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Procedure time;Rate of correct placement of the flow diverter at the exact planned location ;Complete apposition of the flow diverter to the walls of the internal carotid artery ;Incidence of flow diverter twisting ;Use of a microballoon to achieve proper deployment and positioning of the flow diverter ;Incidence of in-stent thrombus during treatment ;Immediate aneurysm occlusion ;Contrast stagnation within the aneurysm immediately after the procedure ;Incidence of occlusion of arterial branches covered by the flow diverter;In-stent stenosis rate;Evaluate stent mesh deformity (F2B2): whether any deformity occurred, including shortening, proximal fish mouth, distal fish mouth, hump-like mesh dilation, proximal mesh collapse, mid-segment collapse, and distal mesh collapse.;Evaluate complications such as hemorrhages (inguinal, retroperitoneal, peripheral from other locations), clinical complications such as hospital-acquired infections, neurological complications such as ischemic or hemorrhagic stroke (parenchymal, intraventricular, or subarachnoid hemorrhage), and the need for surgical or neurosurgical procedures for the management of complications. | — |
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