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 Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention group Microport NeuroTech Tubridge flow-diverter Stent |
Device: Tubridge
Intracranial stent for wide-necked aneurysms
|
Outcome Measures
Primary Outcome Measures
- Complete occlusion rate of aneurysms [180±30 days]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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(1) Age 18-75 years;
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(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) ;
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(3) Aneurysm neck ≥ 4 mm or aneurysm body to neck ratio < 2;
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(4) Parent artery diameter of 2.0 mm to 6.5 mm;
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(5) Subjects suitable for treatment with the Tubridge stent alone or in combination with coil;
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(6) The subject is willing to be followed up in accordance the protocol;
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(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:
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(1) Aneurysm associated with AVM, MMD;
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(2) Ruptured aneurysms within 30 days;
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(3) Multiple aneurysms;
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(4) Subjects with severe stenosis (≥50% stenosis) or occlusion of the parent artery;
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(5) Aneurysms that have recurred after treatment with stents or stent-assisted coiling embolization
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(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)
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(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;
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(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;
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(9) mRS score ≥ 3;
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(10) Subjects with a life expectancy of less than 12 months;
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(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;
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(12) Subjects who, in the judgment of the investigator, have poor adherence and are unable to complete the study as required;
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(13) Subjects with a suspected history of allergy to materials such as nickel-titanium, platinum, or platinum-iridium alloys;
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(14) Subjects who are unable to receive antiplatelet aggregation or anticoagulation therapy;
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(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;
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(16) Women who are pregnant or breastfeeding;
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(17) Other conditions deemed by the investigator to be inappropriate for study participation.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shanghai Changhai Hospital | Shanghai | China |
Sponsors and Collaborators
- MicroPort NeuroTech Co., Ltd.
Investigators
- Principal Investigator: Jianmin Liu, Changhai Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Tubridge-2022-02-0A