Status unknownNCT05275296PROMISEUpdated Mar 11, 2022

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

An interventional study of Intracranial stent for wide-necked aneurysms in Brain Diseases, Aneurysm and Intracranial Aneurysm, sponsored by MicroPort NeuroTech Co., Ltd.. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-03-11.

Sponsored by MicroPort NeuroTech Co., Ltd. · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2022), so the status shown — last known as Recruiting — may be out of date.

Phase: Not applicable
Study type: Interventional
Enrollment: 200
Allocation: Randomized
Ages: 18 Years to 80 Years
Sex: All

Study summary

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

Conditions studied

Brain Diseases
Aneurysm
Intracranial Aneurysm
Cardiovascular Diseases

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In context

Intracranial Aneurysm

427 studies on the registry are indexed under Intracranial Aneurysm; 115 are open to participants now.

This study's planned enrollment of 200 is above the median of 110 across 207 interventional studies indexed under Intracranial Aneurysm.

Browse Intracranial Aneurysm studies →

Lead sponsor

MicroPort NeuroTech Co., Ltd. is the lead sponsor of 13 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 200 participants (estimated)

Study arms

Experimental
experimental group
Microport NeuroTech Intracranial Visualized Stent
Device: Intracranial stent for wide-necked aneurysms
Active comparator
control group
LVIS™ and LVIS™ Jr
Device: Intracranial stent for wide-necked aneurysms

Interventions

DeviceIntracranial stent for wide-necked aneurysms
Intracranial stent for wide-necked aneurysms

What researchers measure

Primary outcomes

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: Time Frame: 360±60 days

Secondary outcomes

Complete 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. Complete occlusion rate includes Class I
Time frame: Time Frame: 360±30 days
Retreatment rate
Percentage of subjects who had aneurysm recurrence and underwent a secondary suergry during follow-up
Time frame: Time Frame: 360±30 days
Successful stent placement
Successful stent placement was defined as the stent was successfully released at the appropriate position, and covered the aneurysm's neck completely while the parent artery remained unobstructed postoperatively.
Time frame: Intraoperation
Incidence od in-stent stenosis (≥50%)
Time frame: Time Frame: 360±30 days
Incidence of device-relared stroke or death
Time frame: perioperative
Incidence of ipsilateral stroke of neurological death
Time frame: Time Frame: 360±30 days
Incidence of device-related severe adverse event
Time frame: Time Frame: 360±30 days
Incidence of aneurysm rupture
Time frame: Time Frame: 360±30 days

Study locations

1 of 1 sites recruiting

First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
- Sheng Guan · Contact · gsradio@126.com
Recruiting

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 11, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05275296
Lead sponsor: MicroPort NeuroTech Co., Ltd.
Responsible party: Sponsor
First posted: Mar 11, 2022
Start date: Jan 24, 2022
Primary completion: Dec 31, 2023 (estimated)
Completion: Dec 31, 2023 (estimated)
Last update: Mar 11, 2022

Study contacts

Huina Lu

Contact

HuiNa.Lu@microport.com

15901703529

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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MicroPort NeuroTech Co., Ltd.

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