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

NCT05275296 | Unknown

• 1 other identifier: Mermaid-2021-01-A
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Adequate occlusion rate of aneurysms

  The Raymond-Roy intracranial aneurysm occlusion classification was used to assess the rate of aneurysm occlusion postoperatively or at the time of primary endpoint assessment (12 months). Occlusion rates were reported as Class I: complete occlusion; Class II: residual neck; Class III: residual aneurysm. Adequate occlusion rate includes Class I and Class II.

  Time Frame: 360±60 days

Secondary Outcomes (8)

• Complete occlusion rate of aneurysms

  Time Frame: 360±30 days

• Retreatment rate

  Time Frame: 360±30 days

• Successful stent placement

  Intraoperation

• Incidence od in-stent stenosis (≥50%)

  Time Frame: 360±30 days

• Incidence of device-relared stroke or death

  perioperative

Study Arms (2)

experimental group

EXPERIMENTAL

Microport NeuroTech Intracranial Visualized Stent

Device: Intracranial stent for wide-necked aneurysms

control group

ACTIVE COMPARATOR

LVIS™ and LVIS™ Jr

Device: Intracranial stent for wide-necked aneurysms

Interventions

Intracranial stent for wide-necked aneurysms DEVICE

Intracranial stent for wide-necked aneurysms

control group; experimental 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:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MicroPort NeuroTech Co., Ltd.: lead

Study Sites (1)

First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

RECRUITING

MeSH Terms

Conditions

Brain Diseases; Aneurysm; Intracranial Aneurysm; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Intracranial Arterial Diseases; Cerebrovascular Disorders

Central Study Contacts

Huina Lu

CONTACT

15901703529; HuiNa.Lu@microport.com

Study Design

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

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: March 11, 2022
• Study Start: January 24, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 11, 2022

Record last verified: 2022-02

Locations

CN (1)