Evaluating a device for treating brain aneurysms

A Prospective, Multicenter, Single Arm Clinical Trial to Evaluate the Safety and Effectiveness of Flow Modulation Device for Intracranial Aneurysms

This study is testing a new device to see if it can safely treat brain aneurysms in patients with unruptured ones.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Shanghai Wallaby Medical Technologies Co.,Inc. (Industry-sponsored)
• Locations: 1 site (Beijing)
• Trial ID: NCT06158750 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and effectiveness of the p64/p48 MW HPC Flow Modulation Device in patients with intracranial aneurysms. It is a prospective, multicenter, single-arm study involving up to 120 patients across 10 sites, with a follow-up period of 12 months. Participants will be treated with the flow modulation device, specifically targeting unruptured saccular or fusiform aneurysms. The study will monitor outcomes related to the device's performance and patient safety over a duration of 32 months.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with diagnosed unruptured saccular or fusiform intracranial aneurysms suitable for endovascular treatment.

Not a fit: Patients with contraindications to antiplatelet therapy or unsuitable anatomical structures for endovascular treatment will not benefit from this study.

Why it matters

Potential benefit: If successful, this device could provide a new, effective treatment option for patients with intracranial aneurysms.

How similar studies have performed: While this approach is novel, similar studies have shown promise in the use of flow modulation devices for treating aneurysms.

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.

Where this trial is running

Beijing

• Xuanwu Hospital, Capital Medical University — Beijing, China (Recruiting)

Study contacts

• Principal investigator: Hongqi Zhang — Xuanwu Hospital, Beijing
• Study coordinator: Wenwen Jia

Conditions Intracranial Aneurysm