Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06189950
Other study ID # Mermaid-2023-01-CIP-00
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 30, 2023
Est. completion date October 30, 2026

Study information

Verified date January 2024
Source MicroPort NeuroTech Co., Ltd.
Contact Huina Lu
Phone 15901703529
Email HuiNa.Lu@microport.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This trial was designed as a prospective, multicentre, open, non-inferiority, randomised controlled clinical trial, with the control devices being MicroVention's LVIS Intraluminal Support Device and LVIS Jr. Intraluminal Support Device. Approximately 200 subjects with intracranial aneurysms would be enrolled for stent-assisted coiling embolisation according to the inclusion and exclusion criteria specified in this trial protocol. Subjects were evaluated by mRS preoperatively, at the time of device implantation, at the time of discharge from the hospital, at 1 month (±7 days) postoperatively, at 6 months (±30 days) postoperatively, and at 12 months (±60 days) postoperatively; subjects would underwent DSA imaging at surgery and at 6 months (±30 days) postoperatively, and MRA or DSA imaging at 12 months (±60 days) postoperatively. Unplanned follow-up of the subjects would performed when necessary, and data would be recorded to evaluate the safety and efficacy of intracranial artery stent for stent-assisted coiling embolisation for the treatment of intracranial aneurysms.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date October 30, 2026
Est. primary completion date October 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 widenecked saccular aneurysms by DSA/CTA/MRA; The target aneurysm should be suitable for stentassisted 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: - Aneurysms unsuitable for stent-assisted coiling (i.e. aneurysm necks = 4 mm and or body-to-neck ratio = 2); The distal diameter of the aneurysm-carrying artery is outside the range of application of the investigational device; mRS score =3; Subjects with recurrent aneurysms treated by stent-assisted coiling; Multiple aneurysms and all aneurysms requiring intervention; Subjects with ruptured aneurysms <30 days ; Significant stenosis (=50%) or occlusion of parent artery; Subjects unsuitable for anaesthesia or endovascular surgical treatment, e.g. major diseases of the heart, lungs, liver, spleen and kidneys, brain tumours, severe active infections, disseminated intravascular coagulation, and a history of severe mental illness; Subjects undergoing major surgical procedures (e.g. tumour resection, surgery of vital organs, etc.) within 30 days prior to signing the informed consent form, or scheduled to undergo such procedures within 60 days after signing the informed consent form; Subjects with morphologies or pathologies that may interfere with device use, including, but not limited to: carotid artery coarctation, vasculitis, aortic coarctation, limited vascular access (e.g., severe intracranial vascular tortuosity, severe intracranial vasospasm unresponsive to medication, other anatomical or clinical pathologies that would prevent access to the device); Contraindications to stenting, including but not limited to: contraindication to DSA, allergy or intolerance to contrast media, allergy or intolerance to antiplatelet and anticoagulant medications required for treatment, allergy to nickel-titanium and platinum-tungsten and platinum-iridium alloys; Pregnant or breastfeeding women; Life expectancy less than 12 months; Subject participation in other drug or device studies that do not meet endpoints

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Intracranial stent for wide-necked aneurysms
Intracranial stent for wide-necked aneurysms

Locations

Country Name City State
China First Affiliated Hospital of Zhengzhou University Zhengzhou Henan

Sponsors (1)

Lead Sponsor Collaborator
MicroPort NeuroTech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of aneurysms with adequate occlusion 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
6 months
Secondary Rate of stent technical success Technical successwas 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. immediately after the procedure
Secondary Rate of aneurysms with complete occlusion 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
6 months
Secondary Rate of in-stent stenosis (=50%) 6 months
Secondary Rate of aneurysms with adequate occlusion 1 year
Secondary Rate of aneurysms with complete occlusion 1 year
Secondary Rate of aneurysms with retreatment Percentage of subjects who had aneurysm recurrence and underwent a secondary suergry during follow-up 1 year
See also
  Status Clinical Trial Phase
Recruiting NCT04870047 - Coating to Optimize Aneurysm Treatment In The New Flow Diverter Generation N/A
Recruiting NCT05968053 - Detection of Microplastics and Nanoplastics in Neurosurgery Patients (DT-MiNi)
Not yet recruiting NCT05665309 - Interest of Pre-operative Use of 3D Printing for Endovascular Treatment of Unruptured Intracranial Aneurysms With Intrasaccular Flow Disruptor N/A
Completed NCT02783339 - Neuroform Atlas Stent for Intracranial Aneurysm Treatment
Withdrawn NCT01194388 - Axium Coil in Completing Endovascular Aneurysm Surgery Study
Completed NCT00071565 - Familial Intracranial Aneurysm Study II N/A
Recruiting NCT05409989 - MicroVention, Inc. Flow Re-Direction Endoluminal Device X (FRED™ X™) Post-Approval Study N/A
Completed NCT03680742 - Contour Neurovascular System - European Pre-Market Unruptured Aneurysm N/A
Completed NCT04872842 - Establishment of Online Registration Platform for Unruptured Intracranial Aneurysms Based on 100 Regional Medical Centers in China and Population Follow-up Study
Terminated NCT02532517 - Study to Evaluate the Safety and Effectiveness of the CODMAN ENTERPRISE® Vascular Reconstruction Device N/A
Completed NCT03663257 - Study to Evaluate Cerebral AneurysmFlow Results in Occlusion
Recruiting NCT05608122 - Establishment of Online Registration Platform for Unruptured Intracranial Aneurysms Based on Regional Medical Centers in China and Population Follow-up Study (Phase Ⅱ)
Recruiting NCT03661463 - Unruptured Intracranial Aneurysm Aspirin Trial (UIAAT). Phase 2
Completed NCT02609867 - A Feasibility Study to Evaluate the Safety and Effectiveness of Implantation of Flowise Cerebral Flow Diverter (Flowise) N/A
Active, not recruiting NCT02292017 - Prospective Packing Density With Target Coils I N/A
Active, not recruiting NCT01872741 - Minipterional Versus Pterional Craniotomy N/A
Completed NCT00993057 - Efficiency of Two Glucose Sampling Protocols for Maintenance of Euglycemia Early Phase 1
Completed NCT00777907 - Complete Occlusion of Coilable Aneurysms Phase 3
Completed NCT00777088 - Pipeline for Uncoilable or Failed Aneurysms N/A
Not yet recruiting NCT05060185 - The Flow Diverter for Treating Patients With Intracranial Aneurysms N/A