A Study of Implantation of CRENEOUS ENTERPRISE 2 Intracranial Stent in Participants With Severe Symptomatic Intracranial Atherosclerotic Stenosis
NCT ID: NCT05316311
Last Updated: 2025-11-10
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
194 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-05-24
Study Completion Date
2026-04-11
Brief Summary
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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.
Detailed Description
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Conditions
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Intracranial Atherosclerosis
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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CERENOVUS ENTERPRISE 2 Intracranial Stent
Participants with severe symptomatic intracranial artery stenosis will be treated with CERENOVUS ENTERPRISE 2 Intracranial Stent.
Group Type
EXPERIMENTAL
CERENOVUS ENTERPRISE 2 Intracranial Stent
Intervention Type
DEVICE
CERENOVUS ENTERPRISE 2 Intracranial Stent will be used to treat severe symptomatic intracranial artery stenosis.
Interventions
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CERENOVUS ENTERPRISE 2 Intracranial Stent
CERENOVUS ENTERPRISE 2 Intracranial Stent will be used to treat severe symptomatic intracranial artery stenosis.
Intervention Type
DEVICE
Eligibility Criteria
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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
* 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
* 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
Minimum Eligible Age
22 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Medos International SARL
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Medos International SARL Clinical Trial
Role: STUDY_DIRECTOR
Medos International SARL
Locations
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Xuanwu Hospital, Capital Medical University
Beijing, , China
Site Status
RECRUITING
West China Hospital of Sichuan University
Chengdu, , China
Site Status
RECRUITING
Haikou People's Hospital
Haikou, , China
Site Status
RECRUITING
First Affiliated Hospital, Harbin Medical University
Harbin, , China
Site Status
RECRUITING
Central Hospital Affiliated to Shandong First Medical University (Jinan Central Hospital)
Jinan, , China
Site Status
RECRUITING
Qilu Hospital of Shandong University
Jinan, , China
Site Status
RECRUITING
Shandong Provincial Hospital
Jinan, , China
Site Status
RECRUITING
Nanjing Drum Tower Hospital
Nanjing, , China
Site Status
RECRUITING
Ningbo First Hospital
Ningbo, , China
Site Status
RECRUITING
Huashan Hospital Fudan University
Shanghai, , China
Site Status
RECRUITING
Wenzhou Central Hospital
Wenzhou, , China
Site Status
RECRUITING
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, , China
Site Status
RECRUITING
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, , China
Site Status
RECRUITING
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, , China
Site Status
RECRUITING
Countries
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China
Central Contacts
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References
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Hurford R, Wolters FJ, Li L, Lau KK, Kuker W, Rothwell PM. Prognosis of Asymptomatic Intracranial Stenosis in Patients With Transient Ischemic Attack and Minor Stroke. JAMA Neurol. 2020 Aug 1;77(8):947-954. doi: 10.1001/jamaneurol.2020.1326.
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BACKGROUND
Zhang Q, Dong K, Song H. Comparison of stent versus medical therapy for symptomatic patients with intracranial atherosclerotic stenosis: A meta-analysis. J Neurol Sci. 2017 Jan 15;372:272-278. doi: 10.1016/j.jns.2016.11.064. Epub 2016 Nov 25.
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BACKGROUND
Krasteva MP, Lau KK, Mordasini P, Tsang ACO, Heldner MR. Intracranial Atherosclerotic Stenoses: Pathophysiology, Epidemiology, Risk Factors and Current Therapy Options. Adv Ther. 2020 May;37(5):1829-1865. doi: 10.1007/s12325-020-01291-4. Epub 2020 Apr 8.
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BACKGROUND
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Other Identifiers
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CNV202003
Identifier Type: OTHER
Identifier Source: secondary_id
CNV202003
Identifier Type: -
Identifier Source: org_study_id