NCT05829746
Recruiting
Not Applicable
PROSPECTIVE, MULTI-CENTER, OPEN-LABEL, SINGLE-ARM REGISTRATION TRIAL OF THE TUBRIDGE FOR THE TREATMENT OF WIDE-NECKED SMALL AND MEDIUM-SIZED INTRACRANIAL ANEURYSMS：PARAT MINI
MicroPort NeuroTech Co., Ltd.1 site in 1 country65 target enrollmentStarted: November 3, 2022Last updated:
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- MicroPort NeuroTech Co., Ltd.
- Enrollment
- 65
- Locations
- 1
- Primary Endpoint
- Complete occlusion rate of aneurysms
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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;
Outcomes
Primary Outcomes
Complete occlusion rate of aneurysms
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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