Clinical trial NCT05275296: Registration Trial of the Intracranial Visualized Stent for the Wide-necked Intracranial Aneurysms
Official title: Prospective, Multi-center, Open-label, Non-inferiority, Randomized, Cotrolled Registration Trial of the Intracranial Visualized Stent for the Wide-necked Intracranial Aneurysms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Brain Diseases
Aneurysm
Intracranial Aneurysm
Cardiovascular Diseases
Lead sponsor: MicroPort NeuroTech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-03-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Adequate occlusion rate of aneurysms
timeFrame: Time Frame: 360±60 days
Secondary outcomes:
measure: Complete occlusion rate of aneurysms
timeFrame: Time Frame: 360±30 days
measure: Retreatment rate
timeFrame: Time Frame: 360±30 days
measure: Successful stent placement
timeFrame: Intraoperation
measure: Incidence od in-stent stenosis (≥50%)
timeFrame: Time Frame: 360±30 days
measure: Incidence of device-relared stroke or death
timeFrame: perioperative
measure: Incidence of ipsilateral stroke of neurological death
timeFrame: Time Frame: 360±30 days
measure: Incidence of device-related severe adverse event
timeFrame: Time Frame: 360±30 days
measure: Incidence of aneurysm rupture
timeFrame: Time Frame: 360±30 days
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: First Affiliated Hospital of Zhengzhou University
state: Henan
Study officials:
References: