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

NCT05898893 | Unknown

• 1 other identifier: TB2-2021-01-0A
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 8

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.

Conditions

Intracranial Aneurysm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

  6months±30 days

• 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

  12months±60 days

• Success rate of stent implantation

  Immediate evaluation after intervention

Study Arms (1)

Intervention group

EXPERIMENTAL

Device: Microport NeuroTech Tubridge Plus flow-diverter Stent

Interventions

Microport NeuroTech Tubridge Plus flow-diverter Stent DEVICE

Intracranial stent for wide-necked aneurysms

Intervention group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years old (as of the date of signing the informed consent form);
• 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);
• The neck of aneurysm 4mm or the body-to-neck ratio of aneurysm \< 2;
• The diameter of the parent vessel is 2.0mm-6.5mm;
• Subjects who are suitable for treatment with Tubridge Plus flow-diverted dense mesh stent alone or in combination with coils;
• Subjects are willing to follow up and evaluate according to the requirements of the clinical trial protocol;
• The subjects or their guardians can understand the purpose of the trial, participate voluntarily and sign the informed consent.

You may not qualify if:

• Aneurysm related to AVM and MMD;
• Ruptured aneurysm within 30 days;
• Multiple aneurysms;
• Subjects with significant stenosis (stenosis rate \>= 50%) or occlusion of parent artery
• Recurrent aneurysms after stent or stent-assisted coil embolization;
• 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);
• 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;
• 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;
• Modified Rankin score \>= 4 points ;
• The life expectancy of the subjects is less than 12 months;
• Subjects who have participated in clinical trials of other drugs or medical devices before enrollment and did not reach the end point.
• The researchers judged that the subjects had poor compliance and could not complete the study as required;
• Subjects with suspected history of allergy to nickel-titanium, platinum, platinum-iridium alloys and other materials;
• Subjects who cannot receive antiplatelet aggregation or anticoagulation therapy;
• Subjects have or may have had a serious reaction to the contrast agent and could not complete the pre-treatment medication;

Sponsors & Collaborators

• MicroPort NeuroTech Co., Ltd.: lead

Study Sites (8)

West China Hospital of Sichuan University

Chendu, China

NOT YET RECRUITING

Huashan Hospital of Fudan University

Shanghai, China

RECRUITING

Shanghai Changhai Hospital

Shanghai, China

NOT YET RECRUITING

Clinical Research Ethics Committee of Shenzhen Second People's Hospital

Shenzhen, China

NOT YET RECRUITING

Zhongnan Hospital, Wuhan University

Wuhan, China

NOT YET RECRUITING

The Second Affiliated Hospital of PLA Air Force Military Medical University

Xi'an, China

RECRUITING

First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

NOT YET RECRUITING

Zhujiang Hospital,Southern Medical University

Zhujiang, China

RECRUITING

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jianmin Liu

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huina Lu

CONTACT

15901703529; HuiNa.Lu@microport.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: June 12, 2023
• Study Start: May 16, 2023
• Primary Completion: March 1, 2024
• Study Completion: December 1, 2024
• Last Updated: June 12, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8)