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Parent Artery Reconstruction for Cerebral Aneurysms Using a Novel Flow Diverter With Surface Modification

Primary Purpose

Cerebral Aneurysm, Cerebral Aneurysm Unruptured

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Cerebral flow diverter
Sponsored by
Sinomed Neurovita Technology Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Aneurysm focused on measuring flow diverter, endovascular therapy

Eligibility Criteria

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

Inclusion Criteria: Age 18 years to 75 years, male or non-pregnant female. Unruptured wide-necked cerebral aneurysms confirmed by preoperative imaging (Wide-necked is defined as width ≥ 4 mm or a dome-to-neck ratio < 2). Parent vessel with a diameter range of 1.75-6.0 mm. Those who voluntarily participate in the study and sign informed consent form. Exclusion Criteria: Subject with target aneurysms are blood blister-like aneurysms, pseudoaneurysms, arteriovenous malformation, moyamoya disease-related aneurysm, or multiple aneurysms that cannot be treated with a single stent. Severe arteriosclerosis or tortuosity of intracranial artery, and the device is difficult to reach the target vessel. Subject with target aneurysm previously treated with craniotomy or other endovascular interventional therapy. Known sensitivity to antiplatelet medications, anticoagulant medications, radiographic contrast agents, anesthetic, nickel, platinum-tungsten alloy, platinum-iridium alloy, and poly-N-[Tris(hydroxymethyl)methyl] acrylamide (poly-NTMA). Severe respiratory system, liver and kidney diseases (such as creatinine ≥ 3.0 mg/dL (except dialysis)) or blood coagulation disorders before operation. Platelet count is less than 100×109/L, international normalized ratio (INR) is more than 1.5. Hospitalized surgical treatment within the previous 30 days or planned within the next 180 days after operation. Severe neurological deficit that renders the patient incapable of living independently (modified Rankin score ≥3). The survival expectation is less than 1 year. All subjects who are participating in other drug/medical device clinical trials and have not completed the programme requirements Inapplicable for this study at the investigators' viewpoints.

Sites / Locations

  • Xuanwu Hospital Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cerebral flow diverter

Arm Description

The cerebral flow diverter in the endovascular treatment of wide-necked cerebral aneurysms

Outcomes

Primary Outcome Measures

Success aneurysm occlusion at 1 year post procedure
The Raymond-Roy occlusion classification (RROC) is an angiographic classification scheme for grading the occlusion of flow diverter treated cerebral aneurysms (class I: complete obliteration, class II: residual neck, class III: residual aneurysm). Higher class represent a worse outcome. The percentage of Success aneurysm occlusion in which class 1 or 2 is achieved on the Raymond Scale at the 1 year follow-up angiographic assessments will be evaluated.

Secondary Outcome Measures

Immediate procedural success rate
Intraoperative cerebrovascular imaging is performed to determine whether the investigational device positions exactly and covers the aneurysm neck effectively.
Complete aneurysm occlusion rate at 180 days and 1 year post procedure
Complete occlusion was defined as complete obliteration of the aneurysm sac, including the neck (Raymond I).
Success aneurysm occlusion at 180 days post procedure
The Raymond-Roy occlusion classification (RROC) is an angiographic classification scheme for grading the occlusion of flow diverter treated cerebral aneurysms (class I: complete obliteration, class II: residual neck, class III: residual aneurysm). Higher class represent a worse outcome. The percentage of Success aneurysm occlusion in which class 1 or 2 is achieved on the Raymond Scale at the 180 days follow-up angiographic assessments will be evaluated.
Complete aneurysm occlusion without significant parent artery stenosis (≤50%) or retreatment at 180 days and 1 year post procedure
Proportion of subjects with complete occlusion of the target aneurysm, ≤50% stenosis of the parent artery at the target cerebral aneurysms at 1 year as assessed by angiography, and in whom an unplanned alternative treatment of the target cerebral aneurysms had not been performed within 1 year.
All-cause mortality at 30 days, 180 days and 1 year post procedure
Deaths due to any cause are calculated.
Any stroke at 30 days, 180 days and 1 year post procedure
Incidence of any stroke including ischemic and hemorrhagic stroke.
Major stroke in the territory supplied by the treated artery or neurological death at 180 days and 1 year post procedure
National Institute of Health Stroke Scale (NIHSS) was used to assess patients after stroke in an 11-item scale with potential scores ranging from 0 to 42. Higher values represent a worse outcome. A major stroke is defined as a new neurological event which is ipsilateral and in the vascular distribution territory of the stenting procedure and that results in an increase of ≥ 4 on the NIHSS as compared to baseline.
Target aneurysmal hemorrhage at 180 days and 1 year post procedure
Percentage (%) of participants who experienced a Target aneurysmal hemorrhage.
Ischemic cerebrovascular events caused by thromboembolism at 180 days and 1 year post procedure
Percentage (%) of participants who experienced ischemic cerebrovascular events caused by thromboembolism.
Incidence of operation or device-related adverse events/serious adverse events during hospitalization, 30 days, 180 days and 1 year post procedure
Percentage (%) of participants who experienced adverse events/serious adverse events.
Rate of Device defect
Device defects refer to the unreasonable risks that may endanger human health and life safety during the normal use of medical devices in the course of clinical trials, such as label errors, quality problems, failures, etc.

Full Information

First Posted
March 6, 2023
Last Updated
April 6, 2023
Sponsor
Sinomed Neurovita Technology Inc.
Collaborators
Xuanwu Hospital, Beijing
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1. Study Identification

Unique Protocol Identification Number
NCT05774782
Brief Title
Parent Artery Reconstruction for Cerebral Aneurysms Using a Novel Flow Diverter With Surface Modification
Official Title
A Prospective, Multi-center, Single Arm Clinical Study to Evaluate the Safety and Effectiveness of the Flow Diverter Stent System in the Treatment of Cerebral Aneurysms
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 27, 2023 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sinomed Neurovita Technology Inc.
Collaborators
Xuanwu Hospital, Beijing

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective of this trial is to evaluate the safety and efficacy of the cerebral flow diverter in the endovascular treatment of wide-necked cerebral aneurysms
Detailed Description
The investigation is a prospective, multi-center, single arm clinical study. The trial is anticipated to last from March 2023 to January 2025 with 143 subjects recruited in around 10 China centers. The population for this study is subjects with wide-necked intracranial aneurysms who are suitable candidates for flow diverter implantation. Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be enrolled after offering informed consent form. The study consists of six visits including preoperative screening, operation date, 7days or at discharge, 30 days, 180 days, and 1 year. The primary endpoint is success aneurysm occlusion at 1 year post procedure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Aneurysm, Cerebral Aneurysm Unruptured
Keywords
flow diverter, endovascular therapy

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Cerebral flow diverter
Arm Type
Experimental
Arm Description
The cerebral flow diverter in the endovascular treatment of wide-necked cerebral aneurysms
Intervention Type
Device
Intervention Name(s)
Cerebral flow diverter
Intervention Description
The surface-modified flow diverter is an intracranial implant designed to be placed in a parent artery so as to divert blood flow away from an aneurysm.
Primary Outcome Measure Information:
Title
Success aneurysm occlusion at 1 year post procedure
Description
The Raymond-Roy occlusion classification (RROC) is an angiographic classification scheme for grading the occlusion of flow diverter treated cerebral aneurysms (class I: complete obliteration, class II: residual neck, class III: residual aneurysm). Higher class represent a worse outcome. The percentage of Success aneurysm occlusion in which class 1 or 2 is achieved on the Raymond Scale at the 1 year follow-up angiographic assessments will be evaluated.
Time Frame
1 year post procedure
Secondary Outcome Measure Information:
Title
Immediate procedural success rate
Description
Intraoperative cerebrovascular imaging is performed to determine whether the investigational device positions exactly and covers the aneurysm neck effectively.
Time Frame
Intra-procedure
Title
Complete aneurysm occlusion rate at 180 days and 1 year post procedure
Description
Complete occlusion was defined as complete obliteration of the aneurysm sac, including the neck (Raymond I).
Time Frame
180 days, 1 year post procedure
Title
Success aneurysm occlusion at 180 days post procedure
Description
The Raymond-Roy occlusion classification (RROC) is an angiographic classification scheme for grading the occlusion of flow diverter treated cerebral aneurysms (class I: complete obliteration, class II: residual neck, class III: residual aneurysm). Higher class represent a worse outcome. The percentage of Success aneurysm occlusion in which class 1 or 2 is achieved on the Raymond Scale at the 180 days follow-up angiographic assessments will be evaluated.
Time Frame
180 days post procedure
Title
Complete aneurysm occlusion without significant parent artery stenosis (≤50%) or retreatment at 180 days and 1 year post procedure
Description
Proportion of subjects with complete occlusion of the target aneurysm, ≤50% stenosis of the parent artery at the target cerebral aneurysms at 1 year as assessed by angiography, and in whom an unplanned alternative treatment of the target cerebral aneurysms had not been performed within 1 year.
Time Frame
180 days, 1 year post procedure
Title
All-cause mortality at 30 days, 180 days and 1 year post procedure
Description
Deaths due to any cause are calculated.
Time Frame
30 days, 180 days and 1 year post procedure
Title
Any stroke at 30 days, 180 days and 1 year post procedure
Description
Incidence of any stroke including ischemic and hemorrhagic stroke.
Time Frame
30 days, 180 days and 1 year post procedure
Title
Major stroke in the territory supplied by the treated artery or neurological death at 180 days and 1 year post procedure
Description
National Institute of Health Stroke Scale (NIHSS) was used to assess patients after stroke in an 11-item scale with potential scores ranging from 0 to 42. Higher values represent a worse outcome. A major stroke is defined as a new neurological event which is ipsilateral and in the vascular distribution territory of the stenting procedure and that results in an increase of ≥ 4 on the NIHSS as compared to baseline.
Time Frame
180 days and 1 year post procedure
Title
Target aneurysmal hemorrhage at 180 days and 1 year post procedure
Description
Percentage (%) of participants who experienced a Target aneurysmal hemorrhage.
Time Frame
180 days and 1 year post procedure
Title
Ischemic cerebrovascular events caused by thromboembolism at 180 days and 1 year post procedure
Description
Percentage (%) of participants who experienced ischemic cerebrovascular events caused by thromboembolism.
Time Frame
180 days and 1 year post procedure
Title
Incidence of operation or device-related adverse events/serious adverse events during hospitalization, 30 days, 180 days and 1 year post procedure
Description
Percentage (%) of participants who experienced adverse events/serious adverse events.
Time Frame
hospitalization, 30 days, 180 days and 1 year post procedure
Title
Rate of Device defect
Description
Device defects refer to the unreasonable risks that may endanger human health and life safety during the normal use of medical devices in the course of clinical trials, such as label errors, quality problems, failures, etc.
Time Frame
within 1 year of whole trial

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 years to 75 years, male or non-pregnant female. Unruptured wide-necked cerebral aneurysms confirmed by preoperative imaging (Wide-necked is defined as width ≥ 4 mm or a dome-to-neck ratio < 2). Parent vessel with a diameter range of 1.75-6.0 mm. Those who voluntarily participate in the study and sign informed consent form. Exclusion Criteria: Subject with target aneurysms are blood blister-like aneurysms, pseudoaneurysms, arteriovenous malformation, moyamoya disease-related aneurysm, or multiple aneurysms that cannot be treated with a single stent. Severe arteriosclerosis or tortuosity of intracranial artery, and the device is difficult to reach the target vessel. Subject with target aneurysm previously treated with craniotomy or other endovascular interventional therapy. Known sensitivity to antiplatelet medications, anticoagulant medications, radiographic contrast agents, anesthetic, nickel, platinum-tungsten alloy, platinum-iridium alloy, and poly-N-[Tris(hydroxymethyl)methyl] acrylamide (poly-NTMA). Severe respiratory system, liver and kidney diseases (such as creatinine ≥ 3.0 mg/dL (except dialysis)) or blood coagulation disorders before operation. Platelet count is less than 100×109/L, international normalized ratio (INR) is more than 1.5. Hospitalized surgical treatment within the previous 30 days or planned within the next 180 days after operation. Severe neurological deficit that renders the patient incapable of living independently (modified Rankin score ≥3). The survival expectation is less than 1 year. All subjects who are participating in other drug/medical device clinical trials and have not completed the programme requirements Inapplicable for this study at the investigators' viewpoints.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
chuan He, Ph.D
Phone
13601110236
Email
streamhe@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongqi Zhang, Ph.D
Organizational Affiliation
Xuanwu Hospital, Beijing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xuanwu Hospital Capital Medical University
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xiaolan Lu
Phone
18015569301
Email
luxiaolan@sinomed.com
First Name & Middle Initial & Last Name & Degree
Hongqi Zhang, Ph.D
First Name & Middle Initial & Last Name & Degree
chuan He, Ph.D

12. IPD Sharing Statement

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Parent Artery Reconstruction for Cerebral Aneurysms Using a Novel Flow Diverter With Surface Modification

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