Intracranial Atherosclerosis
Conditions
Brief summary
The purpose of this study is to evaluate the safety and effectiveness of CERENOVUS ENTERPRISE 2 intracranial stent implantation in treatment of participants with severe symptomatic intracranial atherosclerotic stenosis.
Interventions
DEVICECERENOVUS ENTERPRISE 2 Intracranial Stent
CERENOVUS ENTERPRISE 2 Intracranial Stent will be used to treat severe symptomatic intracranial artery stenosis.
Sponsors
Medos International SARL
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Pre-procedure inclusion criteria * Participants aged 22-80 years old * All participants are required to meet at least one additional criteria (a-f) provided below to qualify for the study; (a) insulin dependent diabetes for at least 15 years; (b) at least 2 of the following atherosclerotic risk factors: hypertension (blood pressure \[BP\] greater than or equal to \[\>=\] 140/90 or on antihypertensive therapy); dyslipidemia (low density lipoprotein \[LDL\] 130 milligrams per deciliter \[mg/dl\] or high density lipoprotein \[HDL\] less than \[\<\] 40 mg/dl or fasting triglycerides \>= 150 mg/dl or on lipid lowering therapy); smoking; abnormal glucose metabolism (fasting blood glucose \>= 6.2 millimole per liter (mmol/L) or 2 hours postprandial blood glucose \>= 7.8mmol/L); family history of any of the following: myocardial infarction, coronary artery bypass, coronary angioplasty or stenting, stroke, carotid endarterectomy or stenting, peripheral vascular surgery in parent or sibling who was \<55 years of age for men or \<65 for women at the time of the event ; (c) history of any of the following: myocardial infarction, coronary artery bypass, coronary angioplasty or stenting, carotid endarterectomy or stenting, or peripheral vascular surgery for atherosclerotic disease ; (d) any stenosis of an extracranial carotid or vertebral artery, another intracranial artery, subclavian artery, coronary artery, iliac or femoral artery, other lower or upper extremity artery, mesenteric artery, or renal artery that was documented by non-invasive vascular imaging or catheter angiography and is considered atherosclerotic ; (e) Aortic arch atheroma or atherosclerotic aortic aneurysm documented by non-invasive vascular imaging or catheter angiography ; (f) High resolution magnetic resonance imaging (MRI) imaging confirmed the presence of atherosclerotic plaques in the target arterial stenosis * Participants with symptomatic intracranial atherosclerotic stenosis who is receiving medical treatment (that is, receiving at least one antithrombotic medication and vascular risk factor management) but still had recurrent (2 or more) ischemic strokes during the medical treatment period within past year * Vascular diameter proximal to the stenosis must be measured at 2.0-4.0 millimeters (mm) * Modified Rankin Scale (mRS) \<= 2 * Stenosis of 70%-99% on non-invasive vascular imaging or digital subtraction angiography (DSA), with normal distal vessel * Participant is willing and able to return for all follow-up visits required by the protocol * Participants understand the purpose and requirements of the study and have signed an informed consent form Intra procedure * Stenosis of 70 percent (%) -99% on digital subtraction angiography (DSA), with normal distal vessel
Exclusion criteria
* Participant underwent an acute ischemic stroke within 2 weeks * Participants in whom one stent can't cover the lesion length or the use of multiple stents is required * Greater than (\>) 50% stenosis proximal or distal to the target intracranial lesion * Intracranial arterial stenosis related to non-atherosclerotic factors, such as: 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 developmental or genetic abnormalities * Participants with symptoms of cerebral ischemia caused by cardiac embolism * Severe vascular tortuosity, highly calcified or anatomy that would preclude the safe introduction of a guiding catheter, guiding sheath or stent placement * Myocardial infarction within previous 30 days * Permanent atrial fibrillation, persistent atrial fibrillation, any episode of paroxysmal atrial fibrillation within the past six months, or history of paroxysmal atrial fibrillation requiring chronic anticoagulation * Intolerance or allergic reaction to any of antithrombotic therapy or medicine used during the procedure * History of life-threatening allergy to contrast medium. If not life threatening and can be effectively pre-treated, participant can be enrolled at investigators' discretion * Surgery within previous 30 days or planned in the next 90 days after enrollment * Intracranial hemorrhage within 3 months * Concomitant intracranial tumor, aneurysm or arteriovenous malformation * Haemoglobin \<10 grams per deciliter (g/dL), blood platelet count \<80000 per milliliters (/ml), international normalization ratio \>1.5, or other uncorrectable coagulopathies. * Life expectancy of \<3 years due to the concomitant illness. * Pregnant or lactating women * Participants judged unsuitable for stenting and angioplasty by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants with In-Stent Restenosis | At 12 months post-procedure | In-stent restenosis greater than (\>) 50 percent (%) at 12 months post-procedure as assessed by an independent Imaging Core Lab will be reported. The percent stenosis of an intracranial artery is calculated according to the warfarin-aspirin symptomatic intracranial disease (WASID) criteria: percent stenosis= (\[1-{Dstenosis/Dnormal}\]) \* 100, where Dstenosis = the diameter of the artery at the site of the most severe stenosis and Dnormal = the diameter of the proximal normal artery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Technical Success | Immediately post-procedure (Day 0) | Technical success immediately post-procedure is defined as complete stent coverage and residual stenosis less than or equal to (\<=) 50% as assessed by an independent Imaging Core Lab. |
| Number of Participants with In-Stent Restenosis | At 6 months post-procedure | In-stent restenosis (\>50%) at 6 months post-procedure as assessed by an independent Imaging Core Lab will be reported. The percent stenosis of an intracranial artery is calculated according to the warfarin-aspirin symptomatic intracranial disease (WASID) criteria: percent stenosis=(\[1-{Dstenosis/Dnormal}\]) \* 100, where Dstenosis = the diameter of the artery at the site of the most severe stenosis and Dnormal = the diameter of the proximal normal artery. |
| National Institutes of Health Stroke Scale (NIHSS) Scores | At 6 months and 12 months post-procedure | NIHSS scores at 6 months and 12 months post-procedure will be reported. NIHSS score is a tool used to objectively quantify the impairment caused by a stroke and to evaluate stroke severity. It ranges from 0 to 42, with 42 being the highest and 0 being the lowest. The higher the NIHSS score, the worse the neurological function. |
| Modified Rankin Scale (mRS) Scores | At 30 days, 6 months and 12 months post-procedure | mRS scores at 30 days, 6 months and 12 months post-procedure will be reported. mRS score is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke. It ranges from 0 to 5. The higher the mRS score, the worse the prognosis. |
| Number of Participants Free of Ischemic Stroke within the Territory of Stented Vessel | From 30 days to 12 months post-procedure | Ischemic stroke within the territory of stented vessel from 30 days to 12 months post-procedure as assessed by the independent clinical events committee will be reported. |
Countries
China
Contacts
STUDY_DIRECTORMedos International SARL Clinical Trial
Medos International SARL
Outcome results
None listed