Last updated: June 1, 2023
Sponsor: MicroPort NeuroTech Co., Ltd.
Overall Status: Active - Recruiting
Phase
N/A
Condition
Aneurysm
Treatment
Microport NeuroTech Tubridge Plus flow-diverter Stent
Clinical Study ID
NCT05898893
TB2-2021-01-0A
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age 18-75 years old (as of the date of signing the informed consent form);
- CTA, MRA or DSA angiography diagnosed as a large intracranial carotid artery orvertebral artery aneurysm (largest diameter of the aneurysm >= 10mm) or medium tosmall aneurysms (maximum diameter <10mm) (including saccular aneurysms and recurrentsaccular aneurysms);
- The neck of aneurysm 4mm or the body-to-neck ratio of aneurysm < 2;
- The diameter of the parent vessel is 2.0mm-6.5mm;
- Subjects who are suitable for treatment with Tubridge Plus flow-diverted dense meshstent alone or in combination with coils;
- Subjects are willing to follow up and evaluate according to the requirements of theclinical trial protocol;
- The subjects or their guardians can understand the purpose of the trial, participatevoluntarily and sign the informed consent.
Exclusion
Exclusion Criteria:
- Aneurysm related to AVM and MMD;
- Ruptured aneurysm within 30 days;
- Multiple aneurysms;
- Subjects with significant stenosis (stenosis rate >= 50%) or occlusion of parentartery
- Recurrent aneurysms after stent or stent-assisted coil embolization;
- Subjects with morphologies or lesions that may interfere with device use, includingbut not limited to: carotid artery dissection, vasculitis, Aortic dissection,restriction of vascular access (such as severe intracranial vascular tortuosity,severe intracranial vasospasm and no response to drug therapy, obstruction of deviceaccess due to other anatomical or clinical lesions);
- Subjects who are not suitable for anesthesia or endovascular treatment, such as severediseases of the heart, lung, liver, spleen, and kidney, brain tumors, severe activeinfection, disseminated intravascular coagulation, and a history of severe mentalillness;
- Subjects who underwent or plan undergo to major surgical operations (such asimplantation of internal fixation devices for extremity fractures, tumor resection,major organ surgery, etc.) within 30 days before signing the informed consent form or 60 days after signing the informed consent form;
- Modified Rankin score >= 4 points ;
- The life expectancy of the subjects is less than 12 months;
- Subjects who have participated in clinical trials of other drugs or medical devicesbefore enrollment and did not reach the end point.
- The researchers judged that the subjects had poor compliance and could not completethe study as required;
- Subjects with suspected history of allergy to nickel-titanium, platinum,platinum-iridium alloys and other materials;
- Subjects who cannot receive antiplatelet aggregation or anticoagulation therapy;
- Subjects have or may have had a serious reaction to the contrast agent and could notcomplete the pre-treatment medication;
- Women who are pregnant or breastfeeding;
- Other conditions deemed inappropriate by the investigator to participate in the study.
Study Design
Total Participants: 99
Treatment Group(s): 1
Primary Treatment: Microport NeuroTech Tubridge Plus flow-diverter Stent
Phase:
Study Start date:
May 16, 2023
Estimated Completion Date:
December 31, 2024
Connect with a study center
West China Hospital of Sichuan University
Chendu,
ChinaSite Not Available
Huashan Hospital of Fudan University
Shanghai,
ChinaActive - Recruiting
Shanghai Changhai Hospital
Shanghai,
ChinaSite Not Available
Clinical Research Ethics Committee of Shenzhen Second People's Hospital
Shenzhen,
ChinaSite Not Available
Zhongnan Hospital, Wuhan University
Wuhan,
ChinaSite Not Available
The Second Affiliated Hospital of PLA Air Force Military Medical University
Xi'an,
ChinaActive - Recruiting
First Affiliated Hospital of Zhengzhou University
Zhengzhou,
ChinaSite Not Available
Zhujiang Hospital,Southern Medical University
Zhujiang,
ChinaActive - Recruiting
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