PROSPECTIVE, MULTI-CENTER, OPEN-LABEL, SINGLE-ARM REGISTRATION TRIAL OF THE TUBRIDGE FOR THE TREATMENT OF WIDE-NECKED SMALL AND MEDIUM-SIZED INTRACRANIAL ANEURYSMS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-03

Study Completion Date

2024-12-31

Brief Summary

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A trial to evaluate the safety and efficacy of the Tubridge flow-diverter stent for the treatment of intracranial wide-necked, small to medium-sized aneurysms.

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Detailed Description

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Conditions

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Brain Diseases Aneurysm Intracranial Aneurysm Cardiovascular Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention group

Microport NeuroTech Tubridge flow-diverter Stent

Group Type EXPERIMENTAL

Tubridge

Intervention Type DEVICE

Intracranial stent for wide-necked aneurysms

Interventions

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Tubridge

Intracranial stent for wide-necked aneurysms

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* (1) Age 18-75 years;
* (2) Subjects with small to medium-sized aneurysms (aneurysm maximum diameter \<10 mm) of the internal carotid artery or vertebral artery diagnosed by CTA, MRA or DSA angiography(including saccular aneurysms and recurrent saccular aneurysms) ;
* (3) Aneurysm neck ≥ 4 mm or aneurysm body to neck ratio \< 2;
* (4) Parent artery diameter of 2.0 mm to 6.5 mm;
* (5) Subjects suitable for treatment with the Tubridge stent alone or in combination with coil;
* (6) The subject is willing to be followed up in accordance the protocol;
* (7) The subject or the subject's guardian understands the purpose of the trial, voluntarily to participate and sign the informed consent form.

Exclusion Criteria

* (1) Aneurysm associated with AVM, MMD;
* (2) Ruptured aneurysms within 30 days;
* (3) Multiple aneurysms;
* (4) Subjects with severe stenosis (≥50% stenosis) or occlusion of the parent artery;
* (5) Aneurysms that have recurred after treatment with stents or stent-assisted coiling embolization
* (6) Subjects with morphology or lesions that may interfere with the use of device , including but not limited to: carotid artery entrapment, vasculitis, aortic entrapment, restricted vascular access (e.g., severe intracranial vascular tortuosity, severe intracranial vasospasm that does not respond to pharmacologic therapy, other anatomic or clinical lesions that prevent device access)
* (7) Subjects who are unsuitable for anesthesia or endovascular surgery, such as major diseases of the heart, lungs, liver, spleen, or kidneys, malignant tumors of the brain, severe active infections, disseminated intravascular coagulation, and a history of severe psychiatric disorders;
* (8) Subjects who have undergone major surgical procedures (e.g., implantation of internal fixation devices for fractures of the extremities, tumor resection, surgery on vital organs, etc.) within 30 days prior to signing the informed consent form or planned within 60 days after signing the informed consent form;
* (9) mRS score ≥ 3;
* (10) Subjects with a life expectancy of less than 12 months;
* (11) Subjects who have participated in other drug or medical device clinical trials prior to enrollment and have not met the study endpoint time frame;
* (12) Subjects who, in the judgment of the investigator, have poor adherence and are unable to complete the study as required;
* (13) Subjects with a suspected history of allergy to materials such as nickel-titanium, platinum, or platinum-iridium alloys;
* (14) Subjects who are unable to receive antiplatelet aggregation or anticoagulation therapy;
* (15) Subjects who have had or are likely to have a reaction to contrast agents so severe that they are unable to complete pre-treatment medication;
* (16) Women who are pregnant or breastfeeding;
* (17) Other conditions deemed by the investigator to be inappropriate for study participation.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No