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

NCT06158750 | Recruiting

• 1 other identifier: TP-1312
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Intracranial Aneurysm

Outcome Measures

Primary Outcomes (1)

• Rate of complete occlusion

  Raymond grade was evaluated by the independent imaging evaluation Committee 12 months after surgery according to the subjects' imaging results, and the rate of complete aneurysm occlusion was calculated. Aneurysm complete occlusion is defined as Raymond Grade I.

  12 months

Secondary Outcomes (7)

• Technical success rate

  Within 24 hours after surgery

• Rate of successful occlusion

  6 months, 12 months

• Rate of complete occlusion

  6 months

• Rate of good clinical prognosis

  3 months, 6 months, 12 months

• Rate of in-stent-stenosis

  to 6 months, to 12 months

Study Arms (1)

Test group

EXPERIMENTAL

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.

Device: p64/p48 MW HPC Flow Modulation Device

Interventions

p64/p48 MW HPC Flow Modulation Device DEVICE

Endovascular intervention with p64/p48 MW HPC Flow Modulation Device was performed in patients diagnosed with intracranial aneurysms

Test group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Wallaby Medical Technologies Co.,Inc.: lead
• Phenox GmbH: collaborator
• Beijing Wallaby Medical Technologies Co.,Inc.: collaborator

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, China

RECRUITING

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Hongqi Zhang

  Xuanwu Hospital, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenwen Jia

CONTACT

+86 18818201005; Wendy.Jia@wallabyphenox.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: December 6, 2023
• Study Start: November 17, 2023
• Primary Completion: February 28, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 27, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)