PARAT PLUS (The Tubridge Plus For The Treatment Of Wide-Necked Intracranial Aneurysms)

Prospective, Multi-Center, Open-Label, Single-Arm Registration Trial Of The Tubridge Plus For The Treatment Of Wide-Necked Intracranial Aneurysms

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

Study Overview

• Status: Recruiting
• Conditions: Intracranial Aneurysm
• Intervention / Treatment: Device: Microport NeuroTech Tubridge Plus flow-diverter Stent

• Study Type: Interventional
• Enrollment (Estimated): 99
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Huina Lu; Phone Number: 15901703529; Email: HuiNa.Lu@microport.com

Study Locations

• China
  • Chendu, China
    • Not yet recruiting
    • West China Hospital of Sichuan University
    • Contact: Xiaodong Xie
  • Shanghai, China
    • Recruiting
    • Huashan Hospital of Fudan University
    • Contact: Yuxiang Gu
  • Shanghai, China
    • Not yet recruiting
    • Shanghai Changhai Hospital
    • Contact: Jianming Liu
  • Shenzhen, China
    • Not yet recruiting
    • Clinical Research Ethics Committee of Shenzhen Second People's Hospital
    • Contact: Jianming Wu
  • Wuhan, China
    • Not yet recruiting
    • Zhongnan Hospital, Wuhan University
    • Contact: Jingcao Chen
  • Xi'an, China
    • Recruiting
    • The Second Affiliated Hospital of PLA Air Force Military Medical University
    • Contact: Zhenwei Zhao
  • Zhengzhou, China
    • Not yet recruiting
    • First Affiliated Hospital of Zhengzhou University
    • Contact: Sheng Guan
  • Zhujiang, China
    • Recruiting
    • Zhujiang Hospital,Southern Medical University
    • Contact: Chuanzhi Duan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group	Device: Microport NeuroTech Tubridge Plus flow-diverter Stent; Intracranial stent for wide-necked aneurysms

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete occlusion（Raymond I） rate of aneurysm at 6 months after procedures	Complete occlusion（Raymond I） rate of aneurysm at 6 months after procedures	6months±30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete occlusion（Raymond I） rate of aneurysm at 12 months after procedures	Complete occlusion（Raymond I） rate of aneurysm at 12 months after procedures	12months±60 days
Successful treatment（Raymond I or II）rate of aneurysm at 6 months after procedures	uccessful treatment（Raymond I or II）rate of aneurysm at 6 months after procedures	6months±30 days
Successful treatment（Raymond I or II）rate of aneurysm at 12 months after procedures	Successful treatment（Raymond I or II）rate of aneurysm at 12 months after procedures	12months±60 days
Retreatment rate of target aneurysm during follow-up	Retreatment rate of target aneurysm during follow-up	12months±60 days
Success rate of stent implantation	Success rate of stent implantation	Immediate evaluation after intervention
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;	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;	12months±60 days
The proportion of subjects with in-stent stenosis (stenosis ≥50% and <100%) within 6 months after procedures	The proportion of subjects with in-stent stenosis (stenosis ≥50% and <100%) within 6 months after procedures	6months±30 days
Proportion of subjects with complete in-stent occlusion within 6 months after procedures	Proportion of subjects with complete in-stent occlusion within 6 months after procedures	6months±30 days
Device-related adverse events, serious adverse events within 1 month, 6 months, and 1 year after procedures	Device-related adverse events, serious adverse events within 1 month, 6 months, and 1 year after procedures	12months±60 days

Collaborators and Investigators

• Sponsor: MicroPort NeuroTech Co., Ltd.
• Investigators: Principal Investigator: Jianmin Liu, Changhai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2023
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: May 11, 2023
• First Submitted That Met QC Criteria: June 1, 2023
• First Posted (Actual): June 12, 2023

Study Record Updates

• Last Update Posted (Actual): June 12, 2023
• Last Update Submitted That Met QC Criteria: June 1, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: TB2-2021-01-0A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No