Intracranial Aneurysm treatment with a Neurostent trial

Not Applicable

Recruiting

• Conditions: nruptured intracranial aneurysm; C10.228.140.300.510.600

• Registration Number: RBR-3q9zb73
• Lead Sponsor: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-05-15
• Last Update Posted: 29 May 2023
• Study Completion: 2025-12-12

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

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

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 < 100,000 cells/mm3 or known platelet dysfunction; Contraindication to the use of study drugs; Presence of a previous neurostent next to the aneurysm to be treated; Presence of a previous surgical clip next to the aneurysm to be treated causing any stenosis of the carotid artery; Known severe allergy to iodinated contrast media defined by previous occurrence of bronchospasm, laryngospasm, circulatory shock; Chronic kidney disease defined by serum creatinine > 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

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>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 Outcome Measures

Name	Time	Method
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)