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

Primary Purpose

Intracranial Aneurysm

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Microport NeuroTech Tubridge Plus flow-diverter Stent
Sponsored by
MicroPort NeuroTech Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracranial Aneurysm

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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; Women who are pregnant or breastfeeding; Other conditions deemed inappropriate by the investigator to participate in the study.

Sites / Locations

  • West China Hospital of Sichuan University
  • Huashan Hospital of Fudan UniversityRecruiting
  • Shanghai Changhai Hospital
  • Clinical Research Ethics Committee of Shenzhen Second People's Hospital
  • Zhongnan Hospital, Wuhan University
  • The Second Affiliated Hospital of PLA Air Force Military Medical UniversityRecruiting
  • First Affiliated Hospital of Zhengzhou University
  • Zhujiang Hospital,Southern Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention group

Arm Description

Outcomes

Primary Outcome Measures

Complete occlusion(Raymond I) rate of aneurysm at 6 months after procedures
Complete occlusion(Raymond I) rate of aneurysm at 6 months after procedures

Secondary Outcome Measures

Complete occlusion(Raymond I) rate of aneurysm at 12 months after procedures
Complete occlusion(Raymond I) rate of aneurysm at 12 months after procedures
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
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
Retreatment rate of target aneurysm during follow-up
Retreatment rate of target aneurysm during follow-up
Success rate of stent implantation
Success rate of stent implantation
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;
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
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
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

Full Information

First Posted
May 11, 2023
Last Updated
June 1, 2023
Sponsor
MicroPort NeuroTech Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05898893
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 16, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MicroPort NeuroTech Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Aneurysm

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
99 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Microport NeuroTech Tubridge Plus flow-diverter Stent
Intervention Description
Intracranial stent for wide-necked aneurysms
Primary Outcome Measure Information:
Title
Complete occlusion(Raymond I) rate of aneurysm at 6 months after procedures
Description
Complete occlusion(Raymond I) rate of aneurysm at 6 months after procedures
Time Frame
6months±30 days
Secondary Outcome Measure Information:
Title
Complete occlusion(Raymond I) rate of aneurysm at 12 months after procedures
Description
Complete occlusion(Raymond I) rate of aneurysm at 12 months after procedures
Time Frame
12months±60 days
Title
Successful treatment(Raymond I or II)rate of aneurysm at 6 months after procedures
Description
uccessful treatment(Raymond I or II)rate of aneurysm at 6 months after procedures
Time Frame
6months±30 days
Title
Successful treatment(Raymond I or II)rate of aneurysm at 12 months after procedures
Description
Successful treatment(Raymond I or II)rate of aneurysm at 12 months after procedures
Time Frame
12months±60 days
Title
Retreatment rate of target aneurysm during follow-up
Description
Retreatment rate of target aneurysm during follow-up
Time Frame
12months±60 days
Title
Success rate of stent implantation
Description
Success rate of stent implantation
Time Frame
Immediate evaluation after intervention
Title
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;
Description
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;
Time Frame
12months±60 days
Title
The proportion of subjects with in-stent stenosis (stenosis ≥50% and <100%) within 6 months after procedures
Description
The proportion of subjects with in-stent stenosis (stenosis ≥50% and <100%) within 6 months after procedures
Time Frame
6months±30 days
Title
Proportion of subjects with complete in-stent occlusion within 6 months after procedures
Description
Proportion of subjects with complete in-stent occlusion within 6 months after procedures
Time Frame
6months±30 days
Title
Device-related adverse events, serious adverse events within 1 month, 6 months, and 1 year after procedures
Description
Device-related adverse events, serious adverse events within 1 month, 6 months, and 1 year after procedures
Time Frame
12months±60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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; Women who are pregnant or breastfeeding; Other conditions deemed inappropriate by the investigator to participate in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huina Lu
Phone
15901703529
Email
HuiNa.Lu@microport.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianmin Liu
Organizational Affiliation
Changhai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
West China Hospital of Sichuan University
City
Chendu
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaodong Xie
Facility Name
Huashan Hospital of Fudan University
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuxiang Gu
Facility Name
Shanghai Changhai Hospital
City
Shanghai
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianming Liu
Facility Name
Clinical Research Ethics Committee of Shenzhen Second People's Hospital
City
Shenzhen
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianming Wu
Facility Name
Zhongnan Hospital, Wuhan University
City
Wuhan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jingcao Chen
Facility Name
The Second Affiliated Hospital of PLA Air Force Military Medical University
City
Xi'an
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhenwei Zhao
Facility Name
First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheng Guan
Facility Name
Zhujiang Hospital,Southern Medical University
City
Zhujiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chuanzhi Duan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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