Implantation of CERENOVUS ENTERPRISE 2 Intracranial Stent in Patients With Severe Symptomatic Intracranial Atherosclerotic Stenosis: A Multicenter, Prospective and Single-Arm Study in China
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.
⁃ 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