Clinical trial NCT05898893: PARAT PLUS (The Tubridge Plus For The Treatment Of Wide-Necked Intracranial Aneurysms)
Official title: Prospective, Multi-Center, Open-Label, Single-Arm Registration Trial Of The Tubridge Plus For The Treatment Of Wide-Necked Intracranial Aneurysms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intracranial Aneurysm
Lead sponsor: MicroPort NeuroTech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-06-12
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A trial to evaluate the safety and efficacy of the Tubridge Plus flow-diverter stent for the treatment of intracranial wide-necked aneurysms.


Eligibility criteria: Inclusion Criteria:

1. Age 18-75 years old (as of the date of signing the informed consent form);
2. CTA, MRA or DSA angiography diagnosed as a large intracranial carotid artery or vertebral artery aneurysm (largest diameter of the aneurysm \>= 10mm) or medium to small aneurysms (maximum diameter \<10mm) (including saccular aneurysms and recurrent saccular aneurysms);
3. The neck of aneurysm 4mm or the body-to-neck ratio of aneurysm \< 2;
4. The diameter of the parent vessel is 2.0mm-6.5mm;
5. Subjects who are suitable for treatment with Tubridge Plus flow-diverted dense mesh stent alone or in combination with coils;
6. Subjects are willing to follow up and evaluate according to the requirements of the clinical trial protocol;
7. The subjects or their guardians can understand the purpose of the trial, participate voluntarily and sign the informed consent.

Exclusion Criteria:

1. Aneurysm related to AVM and MMD;
2. Ruptured aneurysm within 30 days;
3. Multiple aneurysms;
4. Subjects with significant stenosis (stenosis rate \>= 50%) or occlusion of parent artery
5. Recurrent aneurysms after stent or stent-assisted coil embolization;
6. Subjects with morphologies or lesions that may interfere with device use, including but 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 device access due to other anatomical or clinical lesions);
7. Subjects who are not suitable for anesthesia or endovascular treatment, such as severe diseases of the heart, lung, liver, spleen, and kidney, brain tumors, severe active infection, disseminated intravascular coagulation, and a history of severe mental illness;
8. Subjects who underwent or plan undergo to major surgical operations (such as implantation 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;
9. Modified Rankin score \>= 4 points ;
10. The life expectancy of the subjects is less than 12 months;
11. Subjects who have participated in clinical trials of other drugs or medical devices before enrollment and did not reach the end point.
12. The researchers judged that the subjects had poor compliance and could not complete the study as required;
13. Subjects with suspected history of allergy to nickel-titanium, platinum, platinum-iridium alloys and other materials;
14. Subjects who cannot receive antiplatelet aggregation or anticoagulation therapy;
15. Subjects have or may have had a serious reaction to the contrast agent and could not complete the pre-treatment medication;
16. Women who are pregnant or breastfeeding;
17. Other conditions deemed inappropriate by the investigator to participate in the study.

Primary outcomes:
measure: Complete occlusion（Raymond I） rate of aneurysm at 6 months after procedures
timeFrame: 6months±30 days
Secondary outcomes:
measure: Complete occlusion（Raymond I） rate of aneurysm at 12 months after procedures
timeFrame: 12months±60 days
measure: Successful treatment（Raymond I or II）rate of aneurysm at 6 months after procedures
timeFrame: 6months±30 days
measure: Successful treatment（Raymond I or II）rate of aneurysm at 12 months after procedures
timeFrame: 12months±60 days
measure: Retreatment rate of target aneurysm during follow-up
timeFrame: 12months±60 days
measure: Success rate of stent implantation
timeFrame: Immediate evaluation after intervention
measure: The proportion of subjects with ipsilateral stroke or neurogenic death to their target aneurysm at 1 month postoperatively, 6 months postoperatively, and 1 year postoperatively;
timeFrame: 12months±60 days
measure: The proportion of subjects with in-stent stenosis (stenosis ≥50% and <100%) within 6 months after procedures
timeFrame: 6months±30 days
measure: Proportion of subjects with complete in-stent occlusion within 6 months after procedures
timeFrame: 6months±30 days
measure: Device-related adverse events, serious adverse events within 1 month, 6 months, and 1 year after procedures
timeFrame: 12months±60 days
Other outcomes:
Locations:
city: Chendu
country: China
facility: West China Hospital of Sichuan University
city: Shanghai
country: China
facility: Huashan Hospital of Fudan University
city: Shanghai
country: China
facility: Shanghai Changhai Hospital
city: Shenzhen
country: China
facility: Clinical Research Ethics Committee of Shenzhen Second People's Hospital
city: Wuhan
country: China
facility: Zhongnan Hospital, Wuhan University
city: Xi'an
country: China
facility: The Second Affiliated Hospital of PLA Air Force Military Medical University
city: Zhengzhou
country: China
facility: First Affiliated Hospital of Zhengzhou University
city: Zhujiang
country: China
facility: Zhujiang Hospital,Southern Medical University
Study officials:
affiliation: Changhai Hospital
name: Jianmin Liu
role: PRINCIPAL_INVESTIGATOR
References: