to evaluate the safety and effectiveness of flow modulation device for intracranial aneurysms

Conditions: Intracranial Aneurysm

Summary: the purpose of this study is to assess safety and effectiveness of the p64/p48 mw hpc flow modulation device.

title: a prospective, multicenter, single arm clinical trial to evaluate the safety and effectiveness of flow modulation device for intracranial aneurysms. device: p64/p48 mw hpc flow modulation device. study design: prospective, multicenter, single arm clinical study. purpose: to assess safety and effectiveness of p64/p48 mw hpc flow modulation device . study duration: 32 months. sample size: 120 patients. number of sites: ≤10. follow-up time: 12 months.

Eligibility criteria:
inclusion criteria: * aged from 18 to 80 years, male or female; * patients diagnosed as intracranial aneurysms by brain cta/mra/dsa; * patients with unruptured saccular aneurysms or fusiform aneurysm who are clinically determined to use flow modulation device for endovascular treatment; * the diameter of the target aneurysm parent vessel was 1.75-5mm; * patients target aneurysm is planned to be embolized using flow modulation devices only; * the mrs score of the patients was 0-2 * patients understand the purpose of the study, accept the follow-up period, and agree to comply with all requirements, agree to participate in the clinical trial and voluntarily sign the informed consent. exclusion criteria: * patients who have contraindications to antiplatelet and/or anticoagulant therapy or do not start antiplatelet therapy in time before treatment; * patients with anatomical structure is not suitable for endovascular treatment due to severe vascular tortuosity or stenosis shown by angiography; * patients with acute ruptured aneurysm or with a history of intracranial hemorrhage or subarachnoid hemorrhage within 30 days before surgery; * patients with target aneurysm treated with endovascular interventional therapy before enrollment; * known to be allergic to nitinol platinum alloy and angiographic agents; * conditions that in the opinion of the investigators would prevent patients from completing the study, such as the expected survival period of active tumor less than 1-year, high-risk group of cerebral thrombosis, heart failure and atrial fibrillation; * the target aneurysms were blood vesicular aneurysms, pseudoaneurysms, or aneurysms associated with arteriovenous malformation, moyamoya disease, or multiple aneurysms that could not be treated by a single flow modulation device; * serious infection is not controlled and is not suitable for operation; * patients who underwent major surgery or interventional therapy (such as brain, cardiac, chest, abdominal or peripheral vascular) within 30 days before surgery; * obvious abnormal coagulation function or bleeding tendency; * combined with severe renal insufficiency, creatinine greater than or equal to 200umol/l; patients with severe liver diseases (such as acute and chronic hepatitis, cirrhosis), or alt more than 3 times the upper normal limit; * pregnancy, lactation, or women of childbearing age who plan to be pregnant during the study period; * participation in any other clinical trial within 30 days prior to signing informed consent; * other conditions considered by the investigator to be inappropriate for enrollment.