A Study of Implantation of CRENEOUS ENTERPRISE 2 Intracranial Stent in Participants With Severe Symptomatic Intracranial Atherosclerotic Stenosis

NCT05316311 | Completed FDA Device

• 1 other identifier: CNV202003
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 14

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.

Conditions

Intracranial Atherosclerosis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants with In-Stent Restenosis

  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.

  At 12 months post-procedure

Secondary Outcomes (5)

• Number of Participants with Technical Success

  Immediately post-procedure (Day 0)

• Number of Participants with In-Stent Restenosis

  At 6 months post-procedure

• National Institutes of Health Stroke Scale (NIHSS) Scores

  At 6 months and 12 months post-procedure

• Modified Rankin Scale (mRS) Scores

  At 30 days, 6 months and 12 months post-procedure

• Number of Participants Free of Ischemic Stroke within the Territory of Stented Vessel

  From 30 days to 12 months post-procedure

Study Arms (1)

CERENOVUS ENTERPRISE 2 Intracranial Stent

EXPERIMENTAL

Participants with severe symptomatic intracranial artery stenosis will be treated with CERENOVUS ENTERPRISE 2 Intracranial Stent.

Device: CERENOVUS ENTERPRISE 2 Intracranial Stent

Interventions

CERENOVUS ENTERPRISE 2 Intracranial Stent DEVICE

CERENOVUS ENTERPRISE 2 Intracranial Stent will be used to treat severe symptomatic intracranial artery stenosis.

CERENOVUS ENTERPRISE 2 Intracranial Stent

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medos International SARL: lead

Study Sites (14)

Xuanwu Hospital, Capital Medical University

Beijing, China

Location

West China Hospital of Sichuan University

Chengdu, China

Location

Haikou People's Hospital

Haikou, China

Location

First Affiliated Hospital, Harbin Medical University

Harbin, China

Location

Central Hospital Affiliated to Shandong First Medical University (Jinan Central Hospital)

Jinan, China

Location

Qilu Hospital of Shandong University

Jinan, China

Location

Shandong Provincial Hospital

Jinan, China

Location

Nanjing Drum Tower Hospital

Nanjing, China

Location

Ningbo First Hospital

Ningbo, China

Location

Huashan Hospital Fudan University

Shanghai, China

Location

Wenzhou Central Hospital

Wenzhou, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

Location

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

Location

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  BACKGROUND

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  BACKGROUND

MeSH Terms

Conditions

Intracranial Arteriosclerosis

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Medos International SARL Clinical Trial

  Medos International SARL

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: April 7, 2022
• Study Start: May 24, 2022
• Primary Completion: December 24, 2025
• Study Completion: February 6, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

CN (14)