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The Efficacy and Safety of Intracranial Self-expanding DES in Symptomatic Intracranial Atherosclerotic Disease

Primary Purpose

Intracranial Arterial Diseases, Stent Restenosis, Percutaneous Transluminal Angioplasty

Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Self-expanding intracranial drug stent system
Sponsored by
Sinomed Neurovita Technology Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracranial Arterial Diseases focused on measuring Self-expanding intracranial stent, Symptomatic Intracranial Atherosclerotic Disease, In-stent restenosis

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 30 to 75 years of age;
  2. Patients with symptomatic intracranial atherosclerotic stenosis who failed antiplatelet therapy or poor collateral circulation compensation or hypoperfusion in the territory of the culprit artery;
  3. Digital Subtraction Angiography(DSA) showed 70% to 99% stenosis in target intracranial artery
  4. The target lesion was in the internal carotid artery (intracranial segment), middle cerebral artery, vertebral artery (intracranial segment), basilar artery, and it was a single lesion that required surgical treatment;
  5. The target lesion reference diameter must be visually estimated to be ≥2.0 mm and <4.5mm in diameter, and lesion length of ≤34 mm;
  6. mRS < 3;
  7. The onset of the latest transient ischemic attack (TIA) was not limited or ischemic stroke occurred within 2 weeks prior to stenting procedure;
  8. Willingness to participate in this clinical trial and signing the consent form, and be able to complete the corresponding inspections, follow-ups, etc. according to the requirements of the clinical protocol during the clinical trial.

Exclusion Criteria:

  1. The target vessels was complete occlusion
  2. >70% stenosis observed at the intracranial large-vessel distal to the target vessel or >70% stenosis observed at the intracranial/extracranial large-vessel proximal to the target vessel;
  3. Preoperative magnetic resonance showed perforating infarction in the target lesion area;
  4. Preoperative CT showed that there was hemorrhage transformation after infarction in the target vessel area, or a history of primary cerebral hemorrhage, or a history of subarachnoid, subdural and epidural hemorrhage within 30 days before operation, or there was no treatment Chronic subdural hematoma ≥5mm;
  5. Hospitalized surgical treatment within 30 days before operation, or planned hospitalized surgical treatment within 6 months after surgery;
  6. CT showed Severe calcified lesions;
  7. Previously received endovascular treatment or surgical intervention at the target vessel (except for patients with simple balloon dilatation);
  8. Non-atherosclerosis lesions;
  9. Patients with potential sources of cardiac embolism (such as atrial fibrillation, left ventricular thrombosis, myocardial infarction within 6 weeks);
  10. Concomitant intracranial tumor, aneurysm or intracranial arteriovenous malformation;
  11. Known hypersensitivity to aspirin, heparin, clopidogrel, rapamycin (sirolimus), lactic acid polymer, poly-n-butyl methacrylate, nickel-titanium alloy, or contraindications to anesthetics and contrast agents;
  12. Hemoglobin <100g/L, platelet count <100*109/L, International normalized ratio (INR) >1.5 (irreversible) or uncorrectable hemorrhagic factors;
  13. Uncontrollable severe hypertension (systolic blood pressure>180mmHg or diastolic blood pressure>110mmHg);
  14. Known liver or renal insufficiency (ALT> 3x upper limit or AST > 3x upper limit, Serum creatinine>250μmol/L);
  15. Life expectancy < 1 year;
  16. Pregnant/lactating female patients;
  17. Patients with cognitive impairment or mental diseases (except for those with cognitive impairment due to arterial stenosis);
  18. Patients who were participated in other clinical trials within 3 months or participating in other clinical trials who had not yet reached the primary clinical endpoint;
  19. Inapplicable for intravascular stenting treatment as per investigators judgment.

Sites / Locations

  • Beijing Chao-Yang Hospital, Capital Medical University
  • The First Hospital of Jilin University
  • The First People's Hospital of Changzhou
  • The Second Affiliated Hospital of Guangzhou Medical University
  • The First Affiliated Hospital of Harbin Medical University
  • Hangzhou First people's Hospital, Zhejiang University School of Medicine
  • The First Affiliated Hospital of USTC Anhui provincial hospital
  • Qilu Hospital, Shandong University
  • The Affiliated Hospital of Qingdao University
  • Changhai Hospital
  • Shanghai Fourth People's Hospital
  • The First Hospital of Hebei Medical University
  • Yantai Yu Huang Ding hospital
  • The First Affiliated hospital of Zhengzhou hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Self-expanding intracranial drug stent system

Arm Description

All patients receive Percutaneous transluminal angioplasty and stenting with self-expanding intracranial drug stent system (Temporary abbreviations: SINOMED IS-DES)

Outcomes

Primary Outcome Measures

The incidence of In-stent restenosis within 6 months after operation
ISR is defined as stenosis greater than 50% within or immediately adjacent (within 5 mm) to the implanted stents and absolute luminal loss greater than 20% at 6 months follow-up imaging.

Secondary Outcome Measures

Stent success
Stent success is defined as ISS is successfully implanted into the vascular site of the target lesion with balloon pretreatment and the delivery system was successfully withdrawn.
Procedure success
Procedure success is defined as a reduction in the degree of stenosis to ≤ 30% after the application of any interventional treatment method.
Percent of Participants With National Institutes of Health Stroke Scale (NIHSS) Score = 0 or 1 at 6 months follow-up
The National Institutes of Health Stroke Scale (NIHSS) is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. The range of scores is from 0 (normal) to 42 (profound effect of stroke on patient).
Rate of good functional outcomes measured by Modified Rankin Score (mRS)
Modified rankin score measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The range is 0-6 (0 is highest function with no symptoms and 6 is death). This outcome measured percentage of subjects with a "good" functional outcome with a score ranging from 0-2.
Rate of all revascularization and target lesion revascularization
The proportion of patients who had revascularization in target lesion or not
Symptomatic ISR within 6 months
Symptomatic ISR is defined as ISR associated with ischemic event in the territory
Any stroke or death within 30 days after operation, and the incidence of recurrent ischemic stroke in the target vascular area within 31 days to 6 months, 1 year, 2 years after operation.
As a composite endpoint include any stroke or death within 30 days, and the incidence of recurrent ischemic stroke in the target vascular area within 31 days to 6 months, 1 year, 2 years after operation.
Any stroke or death within 30 days after operation
Any stroke, death means death from any cause, including stroke or cerebrovascular disease
Stroke (including hemorrhage or ischemic stroke) or death within 30 days associated with the target vessel
The proportion of patients who had any stroke or died within 30 days after operation in association with stenting implantion
The incidence of recurrent ischemic stroke in the target vascular area within 31 days to 6 months, 1 year, 2 years after operation.
There is clear imaging evidence to confirm that the target vessel area is occluded again, which leads to ischemic stroke.
The incidence of recurrent ischemic stroke outside the target vascular area within 31 days to 6 months, 1 year, 2 years after operation.
There is clear imaging evidence to confirm that outside the target vessel area is occluded again, which leads to ischemic stroke.
Any parenchymal hemorrhage, subarachnoid hemorrhage or intraventricular hemorrhage
There is clear imaging evidence to confirm that the incidence of any parenchymal hemorrhage, subarachnoid hemorrhage or intraventricular hemorrhage
All cause death
The proportion of patients who died from all causes is evaluated from 31 days to 6 months, 1 year, 2 years after operation
Adverse events or severe adverse event
The proportion of Adverse events or severe adverse event
Incidence of device defects
The proportion of device defects in the process of testing, such as label errors, quality problems, malfunctions, etc.

Full Information

First Posted
January 4, 2022
Last Updated
October 13, 2023
Sponsor
Sinomed Neurovita Technology Inc.
Collaborators
Changhai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05217459
Brief Title
The Efficacy and Safety of Intracranial Self-expanding DES in Symptomatic Intracranial Atherosclerotic Disease
Official Title
A Prospective, Multicenter, Objective Performance Criteria Study to Evaluate the Efficacy and Safety of an Intracranial Self-expanding Drug Eluting Stent System for Symptomatic Intracranial Atherosclerotic Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 4, 2022 (Actual)
Primary Completion Date
August 17, 2023 (Actual)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

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

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
The primary objective of this trial is to evaluate the safety and efficacy of SINOMED IS- DES in patients with symptomatic intracranial atherosclerotic stenosis.
Detailed Description
This study is a prospective, multicenter, objective performance criteria clinical trial to evaluate the safety and efficacy of intracranial self-expanding drug stent system in the treatment of symptomatic intracranial atherosclerotic stenosis. A total of 128 patients are planned to be included. The primary endpoint is the incidence of In-stent restenosis at 6 months after operation (ISR is defined as stenosis greater than 50% within or immediately adjacent (within 5 mm) to the implanted stents and absolute luminal loss greater than 20% at 6 months follow-up imaging.). All patients will have clinical follow-up during intraoperative, 30 days, 6 months, 1 year, and 2 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Arterial Diseases, Stent Restenosis, Percutaneous Transluminal Angioplasty
Keywords
Self-expanding intracranial stent, Symptomatic Intracranial Atherosclerotic Disease, In-stent restenosis

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Self-expanding intracranial drug stent system
Arm Type
Experimental
Arm Description
All patients receive Percutaneous transluminal angioplasty and stenting with self-expanding intracranial drug stent system (Temporary abbreviations: SINOMED IS-DES)
Intervention Type
Device
Intervention Name(s)
Self-expanding intracranial drug stent system
Intervention Description
All patients receive Percutaneous transluminal angioplasty and stenting with self-expanding intracranial drug stent system (Temporary abbreviations: SINOMED IS-DES)
Primary Outcome Measure Information:
Title
The incidence of In-stent restenosis within 6 months after operation
Description
ISR is defined as stenosis greater than 50% within or immediately adjacent (within 5 mm) to the implanted stents and absolute luminal loss greater than 20% at 6 months follow-up imaging.
Time Frame
6 months after operation
Secondary Outcome Measure Information:
Title
Stent success
Description
Stent success is defined as ISS is successfully implanted into the vascular site of the target lesion with balloon pretreatment and the delivery system was successfully withdrawn.
Time Frame
Immediately after operative
Title
Procedure success
Description
Procedure success is defined as a reduction in the degree of stenosis to ≤ 30% after the application of any interventional treatment method.
Time Frame
Immediately after operative
Title
Percent of Participants With National Institutes of Health Stroke Scale (NIHSS) Score = 0 or 1 at 6 months follow-up
Description
The National Institutes of Health Stroke Scale (NIHSS) is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. The range of scores is from 0 (normal) to 42 (profound effect of stroke on patient).
Time Frame
6 months after operation
Title
Rate of good functional outcomes measured by Modified Rankin Score (mRS)
Description
Modified rankin score measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The range is 0-6 (0 is highest function with no symptoms and 6 is death). This outcome measured percentage of subjects with a "good" functional outcome with a score ranging from 0-2.
Time Frame
30days, 6 months, 1 year ,2 years after operation
Title
Rate of all revascularization and target lesion revascularization
Description
The proportion of patients who had revascularization in target lesion or not
Time Frame
30days, 31days to 6 months, 1 year, 2 years after operation
Title
Symptomatic ISR within 6 months
Description
Symptomatic ISR is defined as ISR associated with ischemic event in the territory
Time Frame
within 6 months
Title
Any stroke or death within 30 days after operation, and the incidence of recurrent ischemic stroke in the target vascular area within 31 days to 6 months, 1 year, 2 years after operation.
Description
As a composite endpoint include any stroke or death within 30 days, and the incidence of recurrent ischemic stroke in the target vascular area within 31 days to 6 months, 1 year, 2 years after operation.
Time Frame
30days, 31days to 6 months, 1 year, 2 years after operation
Title
Any stroke or death within 30 days after operation
Description
Any stroke, death means death from any cause, including stroke or cerebrovascular disease
Time Frame
Within 30days after operation
Title
Stroke (including hemorrhage or ischemic stroke) or death within 30 days associated with the target vessel
Description
The proportion of patients who had any stroke or died within 30 days after operation in association with stenting implantion
Time Frame
Within 30days after operation
Title
The incidence of recurrent ischemic stroke in the target vascular area within 31 days to 6 months, 1 year, 2 years after operation.
Description
There is clear imaging evidence to confirm that the target vessel area is occluded again, which leads to ischemic stroke.
Time Frame
31days to 6 months, 1 year, 2 years after operation
Title
The incidence of recurrent ischemic stroke outside the target vascular area within 31 days to 6 months, 1 year, 2 years after operation.
Description
There is clear imaging evidence to confirm that outside the target vessel area is occluded again, which leads to ischemic stroke.
Time Frame
31days to 6 months, 1 year, 2 years after operation
Title
Any parenchymal hemorrhage, subarachnoid hemorrhage or intraventricular hemorrhage
Description
There is clear imaging evidence to confirm that the incidence of any parenchymal hemorrhage, subarachnoid hemorrhage or intraventricular hemorrhage
Time Frame
31days to 6 months, 1 year, 2 years after operation
Title
All cause death
Description
The proportion of patients who died from all causes is evaluated from 31 days to 6 months, 1 year, 2 years after operation
Time Frame
31days to 6 months, 1 year, 2 years after operation
Title
Adverse events or severe adverse event
Description
The proportion of Adverse events or severe adverse event
Time Frame
31days to 6 months, 1 year, 2 years after operation
Title
Incidence of device defects
Description
The proportion of device defects in the process of testing, such as label errors, quality problems, malfunctions, etc.
Time Frame
During operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 30 to 75 years of age; Patients with symptomatic intracranial atherosclerotic stenosis who failed antiplatelet therapy or poor collateral circulation compensation or hypoperfusion in the territory of the culprit artery; Digital Subtraction Angiography(DSA) showed 70% to 99% stenosis in target intracranial artery The target lesion was in the internal carotid artery (intracranial segment), middle cerebral artery, vertebral artery (intracranial segment), basilar artery, and it was a single lesion that required surgical treatment; The target lesion reference diameter must be visually estimated to be ≥2.0 mm and <4.5mm in diameter, and lesion length of ≤34 mm; mRS < 3; The onset of the latest transient ischemic attack (TIA) was not limited or ischemic stroke occurred within 2 weeks prior to stenting procedure; Willingness to participate in this clinical trial and signing the consent form, and be able to complete the corresponding inspections, follow-ups, etc. according to the requirements of the clinical protocol during the clinical trial. Exclusion Criteria: The target vessels was complete occlusion; >70% stenosis observed at the intracranial large-vessel distal to the target vessel or >70% stenosis observed at the intracranial/extracranial large-vessel proximal to the target vessel; Preoperative magnetic resonance only showed perforating infarction in the target lesion area; Preoperative CT or MRI showed that there was hemorrhage transformation after infarction in the target vessel area, or a history of primary cerebral hemorrhage, or a history of subarachnoid, subdural and epidural hemorrhage within 30 days before operation, or there was no treatment Chronic subdural hematoma ≥5mm; Hospitalized surgical treatment within 30 days before operation, or planned hospitalized surgical treatment within 6 months after surgery; CT showed Severe calcified lesions; Previously received endovascular treatment or surgical intervention at the target vessel (except for patients with simple balloon dilatation); Non-atherosclerosis lesions; Patients with potential sources of cardiac embolism (such as atrial fibrillation, left ventricular thrombosis, myocardial infarction within 6 weeks); Concomitant intracranial tumor, aneurysm or intracranial arteriovenous malformation; Known hypersensitivity to aspirin, heparin, clopidogrel, rapamycin (sirolimus), lactic acid polymer, poly-n-butyl methacrylate, nickel-titanium alloy, or contraindications to anesthetics and contrast agents; Hemoglobin <100g/L, platelet count <100*109/L, International normalized ratio (INR) >1.5 (irreversible) or uncorrectable hemorrhagic factors; Uncontrollable severe hypertension (systolic blood pressure>180mmHg or diastolic blood pressure>110mmHg); Known liver or renal insufficiency (ALT> 3x upper limit or AST > 3x upper limit, Serum creatinine>250μmol/L); Life expectancy < 1 year; Pregnant/lactating female patients; Patients with cognitive impairment or mental diseases (except for those with cognitive impairment due to arterial stenosis); Patients who were participated in other clinical trials within 3 months or participating in other clinical trials who had not yet reached the primary clinical endpoint; Inapplicable for intravascular stenting treatment as per investigators judgment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jianming Liu, M.D/Ph.D
Organizational Affiliation
Changhai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Chao-Yang Hospital, Capital Medical University
City
Beijing
Country
China
Facility Name
The First Hospital of Jilin University
City
Changchun
Country
China
Facility Name
The First People's Hospital of Changzhou
City
Changzhou
Country
China
Facility Name
The Second Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
Country
China
Facility Name
The First Affiliated Hospital of Harbin Medical University
City
Ha'erbin
Country
China
Facility Name
Hangzhou First people's Hospital, Zhejiang University School of Medicine
City
Hangzhou
Country
China
Facility Name
The First Affiliated Hospital of USTC Anhui provincial hospital
City
Hefei
Country
China
Facility Name
Qilu Hospital, Shandong University
City
Jinan
Country
China
Facility Name
The Affiliated Hospital of Qingdao University
City
Qingdao
Country
China
Facility Name
Changhai Hospital
City
Shanghai
Country
China
Facility Name
Shanghai Fourth People's Hospital
City
Shanghai
Country
China
Facility Name
The First Hospital of Hebei Medical University
City
Shijiazhuang
Country
China
Facility Name
Yantai Yu Huang Ding hospital
City
Yantai
Country
China
Facility Name
The First Affiliated hospital of Zhengzhou hospital
City
Zhengzhou
Country
China

12. IPD Sharing Statement

Learn more about this trial

The Efficacy and Safety of Intracranial Self-expanding DES in Symptomatic Intracranial Atherosclerotic Disease

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