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

MicroPort

Status: Unknown

Conditions: Aneurysm; Cardiovascular Diseases; Intracranial Aneurysm; Brain Diseases

Treatments: Device: Intracranial stent for wide-necked aneurysms

Study type: Interventional

Funder types: Industry

Identifiers

NCT05275296

Mermaid-2021-01-A

Details and patient eligibility

About

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

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

experimental group

Experimental group

Description:

Microport NeuroTech Intracranial Visualized Stent

Treatment:

Device: Intracranial stent for wide-necked aneurysms

control group

Active Comparator group

Description:

LVIS™ and LVIS™ Jr

Treatment:

Device: Intracranial stent for wide-necked aneurysms