Back to resultsA Registry Study of Intracranial Atherosclerotic Stenosis Treatment by Intracranial Drug-eluting Stenting in China
Primary Purpose
Intracranial Arteriosclerosis, Stenosis Artery, Drug-Eluting Stents
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Drug-Eluting Stents
Sponsored by
About this trial
This is an interventional treatment trial for Intracranial Arteriosclerosis focused on measuring endovascular therapy, intracranial drug-eluting stent, symptomatic intracranial artery stenosis (sICAS)
Eligibility Criteria
Inclusion Criteria: Males or females between 18 and 80 years of age; Symptomatic intracranial arteriosclerosis stenosis with reference diameter 2.25-4.00mm; intracranial artery stenosis ( ≥70%) conformed by digital subtraction angiography (DSA); Those who voluntarily participate in the study and sign informed consent form. Exclusion Criteria: Those who have surgery within previous 30 days or plan to perform major surgery in the next 90 days (surgery grade 3 and above); Subjects of acute hemorrhagic stroke within 3 months; The baseline mRS of disabling stroke is more than 3; The target vessel is severely calcified and closely related to stenosis; Non-atherosclerotic diseases (e.g. arterial dissection, Moya Moya disease, vascular inflammatory lesions caused by infection, autoimmune diseases, post-irradiation, postpartum status; developmental or genetic abnormalities such as fibromuscular dysplasia, sickle cell anemia, suspected vasospasm); It is suspected that the ischemic event is due to embolism or arterial embolism from the extracranial segment (including ipsilateral chest or neck vascular occlusive disease) or potential cardiogenic embolism (e.g. atrial fibrillation, mitral stenosis, patent foramen ovale, left ventricular thrombus, myocardial infarction within 6 weeks, etc.); Target artery's supplying artery stenosis > 50%. For example, patient with middle cerebral artery (MCA) severe stenosis (target artery) and the ipsilateral internal carotid artery (ICA) stenosis > 50% should be excluded; patient with basilar artery (BA) severe stenosis (target artery) and the dominant vertical artery (VA) stenosis > 50% should be excluded; There are intracranial tumors, or intracranial arteriovenous malformations; Those who are allergic to heparin, aspirin, clopidogrel, contrast agents, anesthetics, and stent components; Pregnant and lactating women Those who are unable to complete follow-up because of mental illness, cognitive or emotional disorders; Inapplicable for this study at the investigators' viewpoints.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Percutaneous transluminal angioplasty and stenting
Arm Description
All patients will be implanted with Drug-Eluting Stents (NOVA DES).
Outcomes
Primary Outcome Measures
stroke or death within 30 days or any ischemic stroke or revascularization from the original culprit intracranial artery beyond 30 days through 12 months after operation.
The primary outcome was a composite of ischemic/hemorrhagic stroke and all-cause death within 30 days, or any ischemic stroke and revascularization from the original culprit intracranial artery beyond 30 days through 12 months after enrollment.
Secondary Outcome Measures
Rate of any stroke (hemorrhagic/ischemic stroke) in the target blood supply area or all-cause death at 30 days after operation
The rate of Hemorrhagic stroke as well as symptomatic ischemic stroke and any death in the target blood supply area
Rate of any stroke (hemorrhagic/ischemic stroke) in the non-target blood supply area or all-cause death at 30 days after operation
The rate of Hemorrhagic stroke as well as symptomatic ischemic stroke and any death in the non-target blood supply area
Rate of transient ischemic attack at 30 days, 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after operation
Transient ischemic attack (TIA) is a temporary blockage of blood flow to the brain with symptoms last from only a few minutes up to 24 hours
Rate of any stroke (hemorrhagic/ischemic stroke) in the target blood supply area at 3, 6 months, 1, 2, 3, 4 years and 5 years after operation
The rate of Hemorrhagic stroke as well as symptomatic ischemic stroke in the target blood supply area
Rate of any stroke (hemorrhagic/ischemic stroke) in the non-target blood supply area at 3, 6 months, 1, 2, 3, 4 years and 5 years after operation
The rate of Hemorrhagic stroke as well as symptomatic ischemic stroke in the non-target blood supply area
Rate of death (vascular/ non-vascular death) at 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after operation
The cause of death was classified as vascular or nonvascular and based on information obtained from the family, medical records, and death certificates. Vascular death included death due to stroke, myocardial infarction (MI), heart failure, pulmonary embolus, cardiac arrhythmia, or other vascular cause.
Rate of symptomatic in-stent restenosis (ISR) and Revascularization at 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after operation
symptomatic ISR is defined as ISR associated with an ischemic event in the territory. Revascularization is the restoration or improvement of blood supply, and included surgical operation, endovascular procedures, etc.
Rate of modified Rankin Scale (mRS) at 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after operation
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death.
EuroQol-5D (EQ-5D) score at 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after operation
A health state defined by the descriptive EQ-5D system can be described by a five-digit number, each digit indicating the score of the corresponding dimension. For the description component a subject self-rates their health in terms of five dimensions; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using either a three-level or a five-level scale.
Rate of in-stent restenosis at 1, 2, 3, 4 years and 5 years after operation (Optional)
Patients with ≥50% stenosis of the vessel
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.
Rate of bleeding events at 1 years after operation
Bleeding was defined according to Bleeding Academic Research Consortium
Full Information
NCT ID
NCT05692882
First Posted
January 9, 2023
Last Updated
March 19, 2023
Sponsor
Sinomed Neurovita Technology Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05692882
Brief Title
A Registry Study of Intracranial Atherosclerotic Stenosis Treatment by Intracranial Drug-eluting Stenting in China
Official Title
To Evaluate the Safety and Efficacy of the NOVA Intracranial Drug-eluting Stent System in "Real World" Patients With Intracranial Atherosclerotic Stenosis: A Prospective, Multicenter, Post-marketing Registry Clinical Study (NOVA II)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 1, 2023 (Anticipated)
Primary Completion Date
December 30, 2025 (Anticipated)
Study Completion Date
December 30, 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sinomed Neurovita Technology Inc.
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 long-term safety and efficacy of the NOVA intracranial drug-eluting stent system in "real world" patients with intracranial atherosclerotic stenosis.
Detailed Description
The investigation is a prospective, multi-center, single arm clinical study. The trial is anticipated to last from December 2022 to December 2030 with 1000 subjects recruited in around 50 Chinese centers. The population for this study is subjects with intracranial atherosclerotic stenosis who are suitable candidates for stent angioplasty. Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be enrolled after they signed the informed consent form. The study consists of ten visits including preoperative screening, operation date, 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years. The primary outcome was a composite of stroke or death within 30 days or any ischemic stroke or revascularization from the original culprit intracranial artery beyond 30 days through 12 months after operation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Arteriosclerosis, Stenosis Artery, Drug-Eluting Stents, Intracranial Artery Stenosis
Keywords
endovascular therapy, intracranial drug-eluting stent, symptomatic intracranial artery stenosis (sICAS)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Percutaneous transluminal angioplasty and stenting
Arm Type
Experimental
Arm Description
All patients will be implanted with Drug-Eluting Stents (NOVA DES).
Intervention Type
Device
Intervention Name(s)
Drug-Eluting Stents
Intervention Description
The NOVA stent is a sirolimus-eluting stent system designed for intracranial artery stenosis with a rapid exchangeable balloon
Primary Outcome Measure Information:
Title
stroke or death within 30 days or any ischemic stroke or revascularization from the original culprit intracranial artery beyond 30 days through 12 months after operation.
Description
The primary outcome was a composite of ischemic/hemorrhagic stroke and all-cause death within 30 days, or any ischemic stroke and revascularization from the original culprit intracranial artery beyond 30 days through 12 months after enrollment.
Time Frame
1 year after operation
Secondary Outcome Measure Information:
Title
Rate of any stroke (hemorrhagic/ischemic stroke) in the target blood supply area or all-cause death at 30 days after operation
Description
The rate of Hemorrhagic stroke as well as symptomatic ischemic stroke and any death in the target blood supply area
Time Frame
30 days after operation
Title
Rate of any stroke (hemorrhagic/ischemic stroke) in the non-target blood supply area or all-cause death at 30 days after operation
Description
The rate of Hemorrhagic stroke as well as symptomatic ischemic stroke and any death in the non-target blood supply area
Time Frame
30 days after operation
Title
Rate of transient ischemic attack at 30 days, 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after operation
Description
Transient ischemic attack (TIA) is a temporary blockage of blood flow to the brain with symptoms last from only a few minutes up to 24 hours
Time Frame
30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after operation
Title
Rate of any stroke (hemorrhagic/ischemic stroke) in the target blood supply area at 3, 6 months, 1, 2, 3, 4 years and 5 years after operation
Description
The rate of Hemorrhagic stroke as well as symptomatic ischemic stroke in the target blood supply area
Time Frame
3, 6 months, 1, 2, 3, 4 years and 5 years after operation
Title
Rate of any stroke (hemorrhagic/ischemic stroke) in the non-target blood supply area at 3, 6 months, 1, 2, 3, 4 years and 5 years after operation
Description
The rate of Hemorrhagic stroke as well as symptomatic ischemic stroke in the non-target blood supply area
Time Frame
3, 6 months, 1, 2, 3, 4 years and 5 years after operation
Title
Rate of death (vascular/ non-vascular death) at 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after operation
Description
The cause of death was classified as vascular or nonvascular and based on information obtained from the family, medical records, and death certificates. Vascular death included death due to stroke, myocardial infarction (MI), heart failure, pulmonary embolus, cardiac arrhythmia, or other vascular cause.
Time Frame
30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after operation
Title
Rate of symptomatic in-stent restenosis (ISR) and Revascularization at 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after operation
Description
symptomatic ISR is defined as ISR associated with an ischemic event in the territory. Revascularization is the restoration or improvement of blood supply, and included surgical operation, endovascular procedures, etc.
Time Frame
30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after operation
Title
Rate of modified Rankin Scale (mRS) at 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after operation
Description
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death.
Time Frame
30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after operation
Title
EuroQol-5D (EQ-5D) score at 30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after operation
Description
A health state defined by the descriptive EQ-5D system can be described by a five-digit number, each digit indicating the score of the corresponding dimension. For the description component a subject self-rates their health in terms of five dimensions; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using either a three-level or a five-level scale.
Time Frame
30 days, 3, 6 months, 1, 2, 3, 4 years and 5 years after operation
Title
Rate of in-stent restenosis at 1, 2, 3, 4 years and 5 years after operation (Optional)
Description
Patients with ≥50% stenosis of the vessel
Time Frame
1, 2, 3, 4 years and 5 years after operation
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 5 years of whole trial
Title
Rate of bleeding events at 1 years after operation
Description
Bleeding was defined according to Bleeding Academic Research Consortium
Time Frame
1 year after operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males or females between 18 and 80 years of age;
Symptomatic intracranial arteriosclerosis stenosis with reference diameter 2.25-4.00mm;
intracranial artery stenosis ( ≥70%) conformed by digital subtraction angiography (DSA);
Those who voluntarily participate in the study and sign informed consent form.
Exclusion Criteria:
Those who have surgery within previous 30 days or plan to perform major surgery in the next 90 days (surgery grade 3 and above);
Subjects of acute hemorrhagic stroke within 3 months;
The baseline mRS of disabling stroke is more than 3;
The target vessel is severely calcified and closely related to stenosis;
Non-atherosclerotic diseases (e.g. arterial dissection, Moya Moya disease, vascular inflammatory lesions caused by infection, autoimmune diseases, post-irradiation, postpartum status; developmental or genetic abnormalities such as fibromuscular dysplasia, sickle cell anemia, suspected vasospasm);
It is suspected that the ischemic event is due to embolism or arterial embolism from the extracranial segment (including ipsilateral chest or neck vascular occlusive disease) or potential cardiogenic embolism (e.g. atrial fibrillation, mitral stenosis, patent foramen ovale, left ventricular thrombus, myocardial infarction within 6 weeks, etc.);
Target artery's supplying artery stenosis > 50%. For example, patient with middle cerebral artery (MCA) severe stenosis (target artery) and the ipsilateral internal carotid artery (ICA) stenosis > 50% should be excluded; patient with basilar artery (BA) severe stenosis (target artery) and the dominant vertical artery (VA) stenosis > 50% should be excluded;
There are intracranial tumors, or intracranial arteriovenous malformations;
Those who are allergic to heparin, aspirin, clopidogrel, contrast agents, anesthetics, and stent components;
Pregnant and lactating women
Those who are unable to complete follow-up because of mental illness, cognitive or emotional disorders;
Inapplicable for this study at the investigators' viewpoints.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhongrong Miao, MD
Phone
+8613601243293
Email
zhongrongm@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Baixue Jia, MD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhongrong Miao, MD
Organizational Affiliation
Beijing Tiantan Hosptial
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
A Registry Study of Intracranial Atherosclerotic Stenosis Treatment by Intracranial Drug-eluting Stenting in China
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