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PROSPECTIVE, MULTI-CENTER, OPEN-LABEL, SINGLE-ARM REGISTRATION TRIAL OF THE TUBRIDGE FOR THE TREATMENT OF WIDE-NECKED SMALL AND MEDIUM-SIZED INTRACRANIAL ANEURYSMS

Primary Purpose

Brain Diseases, Aneurysm, Intracranial Aneurysm

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

About this trial

This is an interventional treatment trial for Brain Diseases

Eligibility Criteria

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

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; (11) Subjects who have participated in other drug or medical device clinical trials prior to enrollment and have not met the study endpoint time frame; (12) Subjects who, in the judgment of the investigator, have poor adherence and are unable to complete the study as required; (13) Subjects with a suspected history of allergy to materials such as nickel-titanium, platinum, or platinum-iridium alloys; (14) Subjects who are unable to receive antiplatelet aggregation or anticoagulation therapy; (15) Subjects who have had or are likely to have a reaction to contrast agents so severe that they are unable to complete pre-treatment medication; (16) Women who are pregnant or breastfeeding; (17) Other conditions deemed by the investigator to be inappropriate for study participation.

Sites / Locations

  • Shanghai Changhai HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention group

Arm Description

Microport NeuroTech Tubridge flow-diverter Stent

Outcomes

Primary Outcome Measures

Complete occlusion rate of aneurysms
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 Outcome Measures

Full Information

First Posted
April 13, 2023
Last Updated
April 13, 2023
Sponsor
MicroPort NeuroTech Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05829746
Brief Title
PROSPECTIVE, MULTI-CENTER, OPEN-LABEL, SINGLE-ARM REGISTRATION TRIAL OF THE TUBRIDGE FOR THE TREATMENT OF WIDE-NECKED SMALL AND MEDIUM-SIZED INTRACRANIAL ANEURYSMS
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 3, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 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 flow-diverter stent for the treatment of intracranial wide-necked, small to medium-sized aneurysms.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Microport NeuroTech Tubridge flow-diverter Stent
Intervention Type
Device
Intervention Name(s)
Tubridge
Intervention Description
Intracranial stent for wide-necked aneurysms
Primary Outcome Measure Information:
Title
Complete occlusion rate of aneurysms
Description
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.
Time Frame
180±30 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: (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; (11) Subjects who have participated in other drug or medical device clinical trials prior to enrollment and have not met the study endpoint time frame; (12) Subjects who, in the judgment of the investigator, have poor adherence and are unable to complete the study as required; (13) Subjects with a suspected history of allergy to materials such as nickel-titanium, platinum, or platinum-iridium alloys; (14) Subjects who are unable to receive antiplatelet aggregation or anticoagulation therapy; (15) Subjects who have had or are likely to have a reaction to contrast agents so severe that they are unable to complete pre-treatment medication; (16) Women who are pregnant or breastfeeding; (17) Other conditions deemed by the investigator to be inappropriate for study participation.
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
Shanghai Changhai Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianmin Liu, Ph.D
Email
liu118@vip.163.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

PROSPECTIVE, MULTI-CENTER, OPEN-LABEL, SINGLE-ARM REGISTRATION TRIAL OF THE TUBRIDGE FOR THE TREATMENT OF WIDE-NECKED SMALL AND MEDIUM-SIZED INTRACRANIAL ANEURYSMS

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