To Evaluate the Safety and Effectiveness of Flow Modulation Device for Intracranial Aneurysms

Shanghai Wallaby Medical Technologies

Status: Enrolling

Conditions: Intracranial Aneurysm

Treatments: Device: p64/p48 MW HPC Flow Modulation Device

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06158750

TP-1312

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Test group

Experimental group

Description:

Patients can be included in the study if they meet all of the inclusion and none of the exclusion criteria and have provided written informed consent, intent to use Flow modulation device to treat intracranial aneurysm.

Treatment:

Device: p64/p48 MW HPC Flow Modulation Device