Overview
The purpose of this study is to assess safety and effectiveness of the p64/p48 MW HPC Flow Modulation Device.
Description
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
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.