Clinical trial NCT06158750: To Evaluate the Safety and Effectiveness of Flow Modulation Device for Intracranial Aneurysms
Official title: A Prospective, Multicenter, Single Arm Clinical Trial to Evaluate the Safety and Effectiveness of Flow Modulation Device for Intracranial Aneurysms
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intracranial Aneurysm
Lead sponsor: Shanghai Wallaby Medical Technologies Co.,Inc.
Sponsor class: INDUSTRY
Collaborators: name: Phenox GmbH
name: Beijing Wallaby Medical Technologies Co.,Inc.
First posted: 2023-12-06
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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 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.

Primary outcomes:
measure: Rate of complete occlusion
timeFrame: 12 months
Secondary outcomes:
measure: Technical success rate
timeFrame: Within 24 hours after surgery
measure: Rate of successful occlusion
timeFrame: 6 months, 12 months
measure: Rate of complete occlusion
timeFrame: 6 months
measure: Rate of good clinical prognosis
timeFrame: 3 months, 6 months, 12 months
measure: Rate of in-stent-stenosis
timeFrame: to 6 months, to 12 months
measure: Device performance evaluation
timeFrame: Within 24 hours after surgery
measure: Death, stroke, and thrombotic events
timeFrame: to 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Hongqi Zhang
role: PRINCIPAL_INVESTIGATOR
References: