Symptomatic Non-acute Intracranial Artery Occlusion, Ischemic Stroke
Conditions
Keywords
Endovascular Recanalization, Symptomatic Non-acute intracranial artery occlusion
Brief summary
A multicenter, randomized, open-label, endpoint-blinded trial to compare the effects of endovascular recanalization plus aggressive medical management with aggressive medical management alone on stroke recurrence and mortality in patients with symptomatic non-acute intracranial artery occlusion.
Detailed description
This is a multicenter, randomized, open-label, endpoint-blinded trial comparing endovascular recanalization (ER) plus aggressive medical management (AMM) with aggressive medical management alone in patients with symptomatic non-acute intracranial artery occlusion. Randomization will be performed using a central interactive web response system (IWRS) with a 1:1 minimization method, stratified by age (\<65 years vs ≥65 years), time from the last ischemic event to randomization (14-30 days vs 30-90 days), and occlusion site (anterior circulation vs posterior circulation). The primary endpoint is a composite of any stroke or death within 30 days after randomization or ischemic stroke in the same region as the qualifying artery between 30 days and 1 year after randomization.
Interventions
PROCEDUREEndovascular Recanalization Strategy
Balloon angioplasty and/or stenting;Combined with aggressive medical management.
100 mg aspirin per day throughout the follow-up period and 75 mg clopidogrel per day (or ticagrelor or cilostazol) for the initial 90 days after randomization;Cerebrovascular risk factor management.
Sponsors
Feng Gao
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Clinical inclusion criteria: 1. Age ranging between 18 and 80 years. 2. Ischemic events (TIA or ischemic stroke) related to the occluded artery, occurring despite aggressive medical management, with the last event occurring within between 14 and 90 days prior to enrollment. 3. The modified Rankin Scale (mRS) score 0-2 at the time of enrollment. 4. At least one risk factor for atherosclerosis. 5. All enrolled patients refused bypass surgery. 6. Signatured informed consent form. Imaging inclusion criteria: 1. Occlusion of intracranial ICA, M1 segment of MCA, intracranial VA (with contralateral VA hypoplasia or occlusion), or BA, as confirmed by CT angiography (CTA) or digital subtraction angiography (DSA), and the length of the cclusion segment was≤15mm. 2. A decrease of \>30% in cerebral blood flow in the territory distal to the target region, as assessed by CT perfusion (CTP); or inadequate collateral compensation indicated by digital subtraction angiography (DSA), defined as an ASITN/SIR collateral grade of 0-2; or evidence of hemodynamic ischemic lesions on CT or MRI. 3. Alberta Stroke Program Early CT Score (ASPECTS) ≥ 6 for anterior circulation occlusion, or posterior circulation ASPECTS (pc-ASPECTS) ≥ 6 and pons-midbrain index (PMI) \< 3 for posterior circulation occlusion, as demonstrated by CT or MRI. 4. Technical feasibility of endovascular recanalization (ER) in the qualifying artery evaluated by two experienced interventional neuroradiologists.
Exclusion criteria
1. Severe stenosis (70%-99%) or occlusion of other arteries, or tandem stenosis (70%-99%) that is proximal to the qualifying artery. 2. Intracranial hemorrhagic diseases such as definite Intracranial tumors, any intracranial vascular malformations, hemorrhagic transformation of infarction, spontaneous intracranial hemorrhage (cerebral parenchymal, subarachnoid, subdural, or epidural) within 30 days. 3. Non atherosclerotic intracranial artery disease: arterial dissection, moyamoya disease or moyamoya syndrome demonstrated by imaging examination, or a definite medical history of autoimmune vasculitis. 4. Evidence of cardioembolic embolism such as atrial fibrillation, prosthetic valve(s), infective endocarditis, mitral stenosis, atrial myxoma, intracardiac clot or vegetation, left ventricular aneurysms, etc. 5. Known unstable angina or myocardial infarction within the last 6 months. 6. Intolerance or allergic reaction to any treatment-related medication, including aspirin, clopidogrel, heparin, and local or general anesthetics. 7. History of life-threatening allergy to contrast dye. 8. Severe liver impairment (AST or ALT \> 3 times normal, cirrhosis), serum creatinine \> 3.0 mg/dl. 9. Past history of EC-IC bypass surgery or EVT. 10. Major surgery (including open femoral, aortic, or carotid surgery) within previous 30 days or planned in the next 90 days after enrollment. 11. Late-stage malignant tumors, cachexia, or other serious diseases and an expected life expectancy of less than 1 year. 12. Pregnant, perinatal stage or lactating women. 13. Any other condition (in the opinion of the site investigator) that inappropriate to participate this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Any stroke or death within 30 days after randomization, or ischemic stroke in the same region as the qualifying artery between 30 days and 1 year after randomization | Within 1 year after randomization | Any stroke or death within 30 days after randomization, or ischemic stroke in the same region as the qualifying artery between 30 days and 1 year after randomization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All cause mortality within 1 year after randomization | Within 1 year after randomization | All cause mortality within 1 year after randomization. |
| Ischemic stroke outside the territory of the qualifying artery within 1 year after randomization | Within 1 year after randomization | Ischemic stroke outside the territory of the qualifying artery within 1 year after randomization. |
| Disabling stroke within 1 year after randomization, defined as any of the following | Within 1 year after randomization | Disabling stroke within 1 year after randomization, defined as any of the following: ① modified Rankin Scale (mRS) score ≥3; ② an increase of ≥1 in the mRS score from baseline after stroke; ③ National Institutes of Health Stroke Scale (NIHSS) total score ≥7; ④ an increase of ≥4 in the NIHSS score from baseline after stroke. |
| TIA in the same region as the qualifying artery within 1 year after randomization | Within 1 year after randomization | TIA in the same region as the qualifying artery within 1 year after randomization. |
| Unplanned revascularization (extracranial intracranial bypass surgery or ER) of the qualifying artery within 1 year after randomization | Within 1 year after randomization | Unplanned revascularization (extracranialintracranial bypass surgery or ER) of the qualifying artery within 1 year after randomization. |
| Composite vascular events within 1 year after randomization, including any stroke, unplanned revascularization and myocardial infarction | Within 1 year after randomization | Composite vascular events within 1 year after randomization, including any stroke, unplanned revascularization and myocardial infarction. |
| A quality-of-life measure (EuroQol five dimensions [EQ-5D] scale questionnaire) at 1 year after randomization | Within 1 year after randomization | A quality-of-life measure (EuroQol five dimensions \[EQ-5D\] scale questionnaire) at 1 year after randomization. |
| mRS score at 1 year after randomization | Within 1 year after randomization | mRS score at 1 year after randomization. |
| Re occlusion rate at 1 year after randomization | Within 1 year after randomization | Re occlusion rate at 1 year after randomization. |
| Periprocedural outcomes, including the rate of successful recanalization, and periprocedural complications | At the end of the operation or intraoperative | Periprocedural outcomes, including the rate of successful recanalization, and periprocedural complications: in-stent thrombosis; distal embolism; symptomatic intracranial hemorrhage; parenchymal hematoma type 2 (as defined by the Heidelberg classification); arterial dissection; and vessel perforation. |
Countries
China
Contacts
CONTACTFeng Gao, MD
PRINCIPAL_INVESTIGATORFeng Gao, MD
Beijing Tiantan Hospital
Outcome results
None listed