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

August 4, 2026 updated by: Medos International SARL

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

194

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Xuanwu Hospital, Capital Medical University
      • Chengdu, China
        • West China Hospital of Sichuan University
      • Haikou, China
        • Haikou People's Hospital
      • Harbin, China
        • First Affiliated Hospital, Harbin Medical University
      • Jinan, China
        • Shandong Provincial Hospital
      • Jinan, China
        • Qilu Hospital of Shandong University
      • Jinan, China
        • Central Hospital Affiliated to Shandong First Medical University (Jinan Central Hospital)
      • Nanjing, China
        • Nanjing Drum Tower Hospital
      • Ningbo, China
        • Ningbo First Hospital
      • Shanghai, China
        • Huashan Hospital Fudan University
      • Wenzhou, China
        • Wenzhou Central Hospital
      • Xi'an, China
        • The First Affiliated Hospital of Xi'an Jiaotong University
      • Xi'an, China
        • The Second Affiliated Hospital of Xi'an Jiaotong University
      • Zhengzhou, China
        • The First Affiliated Hospital of Zhengzhou University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CERENOVUS ENTERPRISE 2 Intracranial Stent
Participants with severe symptomatic intracranial artery stenosis will be treated with CERENOVUS ENTERPRISE 2 Intracranial Stent.
Device: CERENOVUS ENTERPRISE 2 Intracranial Stent
CERENOVUS ENTERPRISE 2 Intracranial Stent will be used to treat severe symptomatic intracranial artery stenosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants with In-Stent Restenosis
Time Frame: 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.
At 12 months post-procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Technical Success
Time Frame: 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.
Immediately post-procedure (Day 0)
Number of Participants with In-Stent Restenosis
Time Frame: 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.
At 6 months post-procedure
National Institutes of Health Stroke Scale (NIHSS) Scores
Time Frame: 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.
At 6 months and 12 months post-procedure
Modified Rankin Scale (mRS) Scores
Time Frame: 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.
At 30 days, 6 months and 12 months post-procedure
Number of Participants Free of Ischemic Stroke within the Territory of Stented Vessel
Time Frame: 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.
From 30 days to 12 months post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medos International SARL

Investigators

  • Study Director: Medos International SARL Clinical Trial, Medos International SARL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 24, 2022

Primary Completion (Actual)

December 24, 2025

Study Completion (Actual)

December 24, 2025

Study Registration Dates

First Submitted

March 30, 2022

First Submitted That Met QC Criteria

March 30, 2022

First Posted (Actual)

April 7, 2022

Study Record Updates

Last Update Posted (Actual)

August 7, 2026

Last Update Submitted That Met QC Criteria

August 4, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNV202003 (Other Identifier: Medos International SARL)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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