Registration Trial of the Intracranial Visualized Stent for the Wide-necked Intracranial Aneurysms

NCT ID: NCT05275296

Last Updated: 2022-03-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-24
• Study Completion Date: 2023-12-31

Brief Summary

A registration trial of the Intracranial Visualized stent in the treatment of wide-necked intracranial aneurysms

Conditions

Brain Diseases; Aneurysm; Intracranial Aneurysm; Cardiovascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

experimental group

Microport NeuroTech Intracranial Visualized Stent

Group Type: EXPERIMENTAL

Intracranial stent for wide-necked aneurysms

Intervention Type: DEVICE

Intracranial stent for wide-necked aneurysms

control group

LVIS™ and LVIS™ Jr

Group Type: ACTIVE_COMPARATOR

Intracranial stent for wide-necked aneurysms

Intervention Type: DEVICE

Intracranial stent for wide-necked aneurysms

Interventions

Intracranial stent for wide-necked aneurysms

Intracranial stent for wide-necked aneurysms

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• At the time of signing the informed consent form(ICF), the applicant shall be male or non-pregnant female, aged 18 to 80 years;
• Target aneurysms was diagnosed as intracranial wide-necked saccular aneurysms(neck ≥4mm, or body-neck ratio <2) by DSA/CTA/MRA；
• The diameter of the parent vessel should be 2.0 to 4.5mm;
• The target aneurysm should be suitable for stent-assisted coiling surgery and could be treated through one operation;
• Subject or its legal representative should be able to understand the purpose of this study, also agree to comply with protocol and sign the informed consent form voluntarily.

Exclusion Criteria

• Subject whose mRS score was greater or equal to 3 during the clinical evaluation before enrollment;
• Subject with recurrent aneurysm which was already embolized through stent-assisted coiling surgery;
• Subject with multiple aneurysms that cannot be treated by single stent;
• Subject with aneurysm ruptured within 30 days;
• Subject who is not suitable for anesthesia or endovascular surgery;
• Subject with significant stenosis of the parent arterty(>50%)
• Subject who underwent major sugical procedure (such as internal fixation for limb fractures, tumor resection, surgery for vital organs, etc.) within 30 days before signing the ICF or would underwent major sugical procedure 60 days after signing the ICF;
• Subject who is currently participating in a clinical trial of another drug or device which has not met the primary endpoint, or who are expexted to participate in a clinical trial of another durg or device;
• Subject with conditions or pathological changes which may interfere with the use of instrument, including but not limited to: carotid artery dissection, vasculitis, aortic dissection, etc;
• Subject who is contraindicated with stent-assisted coiling:

Subject with allergy to required anti-platelet and/or heparin medications required for treatment; Subject with allergy to radiographic contrast; Subject with allergy to Nitinol, platinum-tungsten, platinum-iridium alloy.

• Women who is pregnant or now breastfeeding;
• Subject with a life expectancy less than 12 months.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MicroPort NeuroTech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Huina Lu

Role: CONTACT

HuiNa.Lu@microport.com

15901703529

Facility Contacts

Sheng Guan

Role: primary

gsradio@126.com

Other Identifiers

Mermaid-2021-01-A

Identifier Type: -

Identifier Source: org_study_id