Angioplasty and Stenting for Patients With Symptomatic Intracranial Atherosclerosis
Primary Purpose
Intracranial Atherosclerosis
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Percutaneous transluminal angioplasty and stenting
Aspirin plus clopidogrel
Sponsored by
About this trial
This is an interventional treatment trial for Intracranial Atherosclerosis
Eligibility Criteria
Inclusion Criteria:
- Patients aged from 18 to 70 years.
- Complaints of a Symptomatic ICAS: a history of recurrent transient ischemic attacks or an ischemic stroke within 1 year owing to a 70%-99% stenosis in an internal carotid artery, middle cerebral artery, vertebral artery, or basilar artery.
- A length ≤ 15mm of a stenosis in the target vessel and a vessel size >2.5mm.
- Hypoperfusion in the territory of the target vessels, which is determined by CT or MRI in 14 days before stenting.
- CT or MRI scans show no massive cerebral infarction (beyond half of the territory of middle cerebral artery (MCA)), intracranial hemorrhage, epidural or sub-dural hemorrhage, and intracranial brain tumor.
- Patients who understand the purpose of the study and have provided informed consent.
Exclusion Criteria:
- Not able to receive general anesthesia.
- Not able to receive angiographic assessment.
- A stenosis >50% in an extracranial carotid or vertebral artery on the ipsilateral side.
- Infarctions due to the perforators occlusion (determined by MRI scan), which is defined as basal ganglia or brainstem/thalamus infarction related with middle cerebral artery or basilar artery stenosis.
- A high risk (leading to a stroke or death) to deliver the stent to the lesion.
- A previous stent or angioplasty in the target lesion.
- Progressive neurological signs within 24 hours before enrolment
- Any haemorrhagic infarct within 14 days before enrolment
- The presence of a cardiac source of embolus
- Thrombolytic therapy within 24 hours before enrollment
- Presence of intraluminal thrombus proximal to or at the target lesion
- Myocardial infarction within previous 30 days
- Non-atherosclerotic lesions: arterial dissection, moya-moya disease; vasculitic disease; herpes zoster, varicella zoster or other viral vasculopathy; neurosyphilis; any other intracranial infection; any intracranial stenosis associated with cerebrospinal fluid pleocytosis; radiation-induced vasculopathy; fibromuscular dysplasia; sickle cell disease; neurofibromatosis; benign angiopathy of central nervous system; postpartum angiopathy; suspected vasospastic process, and suspected recanalized embolus.
- Known contraindications for aspirin and clopidogrel treatment.
- An modified Rankin scale≥3.
- With a childbearing potential or a positive pregnancy test in 1 week before enrolment.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
stenting+medical treatment
Aspirin plus clopidogrel
Arm Description
Patients in PTAS+MT group will receive Percutaneous transluminal angioplasty and stenting and medical treatment (aspirin 100mg daily and clopidogrel 75mg daily)
Patients in aspirin plus clopidogrel group will receive aspirin 100mg daily and clopidogrel 75mg daily for 90 days.
Outcomes
Primary Outcome Measures
Proportion of patients with events of stroke or death
Secondary Outcome Measures
the incidence of recurrent ischaemic stroke in the stenting-involved vascular territory
neurological functional outcome by the Chinese version of National Institutes of Health Stroke Scale (C-NIHSS)
Proportion of patients with adverse events
Full Information
NCT ID
NCT02689037
First Posted
February 17, 2016
Last Updated
April 4, 2016
Sponsor
The 476th Hospital of People's Liberation Army
1. Study Identification
Unique Protocol Identification Number
NCT02689037
Brief Title
Angioplasty and Stenting for Patients With Symptomatic Intracranial Atherosclerosis
Official Title
Angioplasty and Stenting for Patients With Symptomatic Intracranial Atherosclerosis: Study Protocol of a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The 476th Hospital of People's Liberation Army
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Background: Effectiveness of Percutaneous transluminal angioplasty and stenting (PTAS) on prevention of events of stroke and death in patients with symptomatic intracranial atherosclerosis (ICAS) is controversial.
Aim: to determine whether PTAS plus medical treatment (MT) are superior to MT alone in preventing events of stroke and death in patients with symptomatic ICAS.
Methods: The investigators will carry out a randomized controlled trial in 3 hospitals in China. A total of 198 patients with ICAS will be randomized into 2 groups: PTAS+MT and MT group. All patients will receive aspirin (100 mg daily) and clopidogrel (75 mg daily) immediately after randomization, and patients in PTAS+MT group will receive surgery within 5 days after randomization. The patients will be followed up for 1 year after randomization and assessed for events of stroke and death at 30 days and 1 year after randomization, the incidence of recurrent ischaemic stroke in the stenting-involved vascular territory at 30 days and 1 year after randomization, incidence of in-stent restenosis at 1 year after randomization,etc.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Atherosclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
394 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
stenting+medical treatment
Arm Type
Experimental
Arm Description
Patients in PTAS+MT group will receive Percutaneous transluminal angioplasty and stenting and medical treatment (aspirin 100mg daily and clopidogrel 75mg daily)
Arm Title
Aspirin plus clopidogrel
Arm Type
Active Comparator
Arm Description
Patients in aspirin plus clopidogrel group will receive aspirin 100mg daily and clopidogrel 75mg daily for 90 days.
Intervention Type
Procedure
Intervention Name(s)
Percutaneous transluminal angioplasty and stenting
Other Intervention Name(s)
PTAS
Intervention Description
Surgeons will plant stents after vascular angioplasty in target ICAS vessels within 5 days after randomization.
Intervention Type
Drug
Intervention Name(s)
Aspirin plus clopidogrel
Other Intervention Name(s)
Aspirin+clopidogrel
Intervention Description
aspirin 100mg daily and clopidogrel 75mg daily for 90 days
Primary Outcome Measure Information:
Title
Proportion of patients with events of stroke or death
Time Frame
at 30 days after randomization
Secondary Outcome Measure Information:
Title
the incidence of recurrent ischaemic stroke in the stenting-involved vascular territory
Time Frame
30 days and 1 year after randomization
Title
neurological functional outcome by the Chinese version of National Institutes of Health Stroke Scale (C-NIHSS)
Time Frame
30 days and 1 year after randomization
Title
Proportion of patients with adverse events
Time Frame
30 days and 1 year after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged from 18 to 70 years.
Complaints of a Symptomatic ICAS: a history of recurrent transient ischemic attacks or an ischemic stroke within 1 year owing to a 70%-99% stenosis in an internal carotid artery, middle cerebral artery, vertebral artery, or basilar artery.
A length ≤ 15mm of a stenosis in the target vessel and a vessel size >2.5mm.
Hypoperfusion in the territory of the target vessels, which is determined by CT or MRI in 14 days before stenting.
CT or MRI scans show no massive cerebral infarction (beyond half of the territory of middle cerebral artery (MCA)), intracranial hemorrhage, epidural or sub-dural hemorrhage, and intracranial brain tumor.
Patients who understand the purpose of the study and have provided informed consent.
Exclusion Criteria:
Not able to receive general anesthesia.
Not able to receive angiographic assessment.
A stenosis >50% in an extracranial carotid or vertebral artery on the ipsilateral side.
Infarctions due to the perforators occlusion (determined by MRI scan), which is defined as basal ganglia or brainstem/thalamus infarction related with middle cerebral artery or basilar artery stenosis.
A high risk (leading to a stroke or death) to deliver the stent to the lesion.
A previous stent or angioplasty in the target lesion.
Progressive neurological signs within 24 hours before enrolment
Any haemorrhagic infarct within 14 days before enrolment
The presence of a cardiac source of embolus
Thrombolytic therapy within 24 hours before enrollment
Presence of intraluminal thrombus proximal to or at the target lesion
Myocardial infarction within previous 30 days
Non-atherosclerotic lesions: arterial dissection, moya-moya disease; vasculitic disease; herpes zoster, varicella zoster or other viral vasculopathy; neurosyphilis; any other intracranial infection; any intracranial stenosis associated with cerebrospinal fluid pleocytosis; radiation-induced vasculopathy; fibromuscular dysplasia; sickle cell disease; neurofibromatosis; benign angiopathy of central nervous system; postpartum angiopathy; suspected vasospastic process, and suspected recanalized embolus.
Known contraindications for aspirin and clopidogrel treatment.
An modified Rankin scale≥3.
With a childbearing potential or a positive pregnancy test in 1 week before enrolment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiao-Ping Cui, MD
Phone
0591-22859529
Email
xiaopingcuidr@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hang Lin, MD
Organizational Affiliation
Fuzhou General Hospital of Nanjing Command, People's Liberation Army and Clinical Medical College of Fujian Medical University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27852711
Citation
Cui XP, Lin M, Mu JS, Ye JX, He WQ, Fu ML, Li H, Fang JY, Shen FF, Lin H. Angioplasty and stenting for patients with symptomatic intracranial atherosclerosis: study protocol of a randomised controlled trial. BMJ Open. 2016 Nov 15;6(11):e012175. doi: 10.1136/bmjopen-2016-012175.
Results Reference
derived
Learn more about this trial
Angioplasty and Stenting for Patients With Symptomatic Intracranial Atherosclerosis
We'll reach out to this number within 24 hrs