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Registration Trial of the Intracranial Visualized Stent for the Wide-necked Intracranial Aneurysms (PROMISE)

Primary Purpose

Brain Diseases, Aneurysm, Intracranial Aneurysm

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Intracranial stent for wide-necked aneurysms
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 - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • At the time of signing the informed consent form(ICF), the applicant shall be male or non-pregnant female, aged 18 to 80 years;
  • Target aneurysms was diagnosed as intracranial wide-necked saccular aneurysms(neck ≥4mm, or body-neck ratio <2) by DSA/CTA/MRA；
  • The diameter of the parent vessel should be 2.0 to 4.5mm;
  • The target aneurysm should be suitable for stent-assisted coiling surgery and could be treated through one operation;
  • Subject or its legal representative should be able to understand the purpose of this study, also agree to comply with protocol and sign the informed consent form voluntarily.

Exclusion Criteria:

  • Subject whose mRS score was greater or equal to 3 during the clinical evaluation before enrollment;
  • Subject with recurrent aneurysm which was already embolized through stent-assisted coiling surgery;
  • Subject with multiple aneurysms that cannot be treated by single stent;
  • Subject with aneurysm ruptured within 30 days;
  • Subject who is not suitable for anesthesia or endovascular surgery;
  • Subject with significant stenosis of the parent arterty(>50%)
  • Subject who underwent major sugical procedure (such as internal fixation for limb fractures, tumor resection, surgery for vital organs, etc.) within 30 days before signing the ICF or would underwent major sugical procedure 60 days after signing the ICF;
  • Subject who is currently participating in a clinical trial of another drug or device which has not met the primary endpoint, or who are expexted to participate in a clinical trial of another durg or device;
  • Subject with conditions or pathological changes which may interfere with the use of instrument, including but not limited to: carotid artery dissection, vasculitis, aortic dissection, etc;
  • Subject who is contraindicated with stent-assisted coiling:

Subject with allergy to required anti-platelet and/or heparin medications required for treatment; Subject with allergy to radiographic contrast; Subject with allergy to Nitinol, platinum-tungsten, platinum-iridium alloy.

  • Women who is pregnant or now breastfeeding;
  • Subject with a life expectancy less than 12 months.

Sites / Locations

  • First Affiliated Hospital of Zhengzhou UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

experimental group

control group

Arm Description

Microport NeuroTech Intracranial Visualized Stent

LVIS™ and LVIS™ Jr

Outcomes

Primary Outcome Measures

Adequate 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. Adequate occlusion rate includes Class I and Class II.

Secondary 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. Complete occlusion rate includes Class I
Retreatment rate
Percentage of subjects who had aneurysm recurrence and underwent a secondary suergry during follow-up
Successful stent placement
Successful stent placement was defined as the stent was successfully released at the appropriate position, and covered the aneurysm's neck completely while the parent artery remained unobstructed postoperatively.
Incidence od in-stent stenosis (≥50%)
Incidence of device-relared stroke or death
Incidence of ipsilateral stroke of neurological death
Incidence of device-related severe adverse event
Incidence of aneurysm rupture

Full Information

First Posted
March 2, 2022
Last Updated
March 2, 2022
Sponsor
MicroPort NeuroTech Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05275296
Brief Title
Registration Trial of the Intracranial Visualized Stent for the Wide-necked Intracranial Aneurysms
Acronym
PROMISE
Official Title
Prospective, Multi-center, Open-label, Non-inferiority, Randomized, Cotrolled Registration Trial of the Intracranial Visualized Stent for the Wide-necked Intracranial Aneurysms
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 24, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (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 registration trial of the Intracranial Visualized stent in the treatment of wide-necked intracranial 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
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Experimental
Arm Description
Microport NeuroTech Intracranial Visualized Stent
Arm Title
control group
Arm Type
Active Comparator
Arm Description
LVIS™ and LVIS™ Jr
Intervention Type
Device
Intervention Name(s)
Intracranial stent for wide-necked aneurysms
Intervention Description
Intracranial stent for wide-necked aneurysms
Primary Outcome Measure Information:
Title
Adequate 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. Adequate occlusion rate includes Class I and Class II.
Time Frame
Time Frame: 360±60 days
Secondary 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. Complete occlusion rate includes Class I
Time Frame
Time Frame: 360±30 days
Title
Retreatment rate
Description
Percentage of subjects who had aneurysm recurrence and underwent a secondary suergry during follow-up
Time Frame
Time Frame: 360±30 days
Title
Successful stent placement
Description
Successful stent placement was defined as the stent was successfully released at the appropriate position, and covered the aneurysm's neck completely while the parent artery remained unobstructed postoperatively.
Time Frame
Intraoperation
Title
Incidence od in-stent stenosis (≥50%)
Time Frame
Time Frame: 360±30 days
Title
Incidence of device-relared stroke or death
Time Frame
perioperative
Title
Incidence of ipsilateral stroke of neurological death
Time Frame
Time Frame: 360±30 days
Title
Incidence of device-related severe adverse event
Time Frame
Time Frame: 360±30 days
Title
Incidence of aneurysm rupture
Time Frame
Time Frame: 360±30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At the time of signing the informed consent form(ICF), the applicant shall be male or non-pregnant female, aged 18 to 80 years; Target aneurysms was diagnosed as intracranial wide-necked saccular aneurysms(neck ≥4mm, or body-neck ratio <2) by DSA/CTA/MRA； The diameter of the parent vessel should be 2.0 to 4.5mm; The target aneurysm should be suitable for stent-assisted coiling surgery and could be treated through one operation; Subject or its legal representative should be able to understand the purpose of this study, also agree to comply with protocol and sign the informed consent form voluntarily. Exclusion Criteria: Subject whose mRS score was greater or equal to 3 during the clinical evaluation before enrollment; Subject with recurrent aneurysm which was already embolized through stent-assisted coiling surgery; Subject with multiple aneurysms that cannot be treated by single stent; Subject with aneurysm ruptured within 30 days; Subject who is not suitable for anesthesia or endovascular surgery; Subject with significant stenosis of the parent arterty(>50%) Subject who underwent major sugical procedure (such as internal fixation for limb fractures, tumor resection, surgery for vital organs, etc.) within 30 days before signing the ICF or would underwent major sugical procedure 60 days after signing the ICF; Subject who is currently participating in a clinical trial of another drug or device which has not met the primary endpoint, or who are expexted to participate in a clinical trial of another durg or device; Subject with conditions or pathological changes which may interfere with the use of instrument, including but not limited to: carotid artery dissection, vasculitis, aortic dissection, etc; Subject who is contraindicated with stent-assisted coiling: Subject with allergy to required anti-platelet and/or heparin medications required for treatment; Subject with allergy to radiographic contrast; Subject with allergy to Nitinol, platinum-tungsten, platinum-iridium alloy. Women who is pregnant or now breastfeeding; Subject with a life expectancy less than 12 months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huina Lu
Phone
15901703529
Email
HuiNa.Lu@microport.com
Facility Information:
Facility Name
First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheng Guan
Email
gsradio@126.com

12. IPD Sharing Statement

Learn more about this trial

Registration Trial of the Intracranial Visualized Stent for the Wide-necked Intracranial Aneurysms

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