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Intracranial AtherosclerosisNCT05316311

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

A study testing CERENOVUS ENTERPRISE 2 Intracranial Stent in people with Intracranial Atherosclerosis, run by Medos International SARL at 14 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 22 to 80 years
Conditions the study is for
Intracranial Atherosclerosis
What is being tested?
CERENOVUS ENTERPRISE 2 Intracranial Stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
194 participants
Where
14 sitesChina
Study dates
24 May 2022to 24 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

China14 sites

  • Xuanwu Hospital, Capital Medical University

    Beijing

  • West China Hospital of Sichuan University

    Chengdu

  • Haikou People's Hospital

    Haikou

  • First Affiliated Hospital, Harbin Medical University

    Harbin

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

    Jinan

  • Qilu Hospital of Shandong University

    Jinan

  • Shandong Provincial Hospital

    Jinan

  • Nanjing Drum Tower Hospital

    Nanjing

  • Ningbo First Hospital

    Ningbo

  • Huashan Hospital Fudan University

    Shanghai

  • Wenzhou Central Hospital

    Wenzhou

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou

Other trials in China

About this study

Official title: 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.

Being tested
CERENOVUS ENTERPRISE 2 Intracranial Stent
Medical subject headings
Intracranial Arteriosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CERENOVUS ENTERPRISE 2 Intracranial StentDevice

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

Study groups in NCT05316311
Study groupRoleWhat they receive
CERENOVUS ENTERPRISE 2 Intracranial StentExperimentalParticipants with severe symptomatic intracranial artery stenosis will be treated with CERENOVUS ENTERPRISE 2 Intracranial Stent.
Receives: Device: CERENOVUS ENTERPRISE 2 Intracranial Stent

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At 12 months post-procedure

Secondary outcomes (5)

  1. Number of Participants with Technical Success

    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.

    Measured: Immediately post-procedure (Day 0)

  2. Number of Participants with In-Stent Restenosis

    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.

    Measured: At 6 months post-procedure

  3. National Institutes of Health Stroke Scale (NIHSS) Scores

    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.

    Measured: At 6 months and 12 months post-procedure

  4. Modified Rankin Scale (mRS) Scores

    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.

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

  5. Number of Participants Free of Ischemic Stroke within the Territory of Stented Vessel

    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.

    Measured: From 30 days to 12 months post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2022
  2. Study start24 May 2022
  3. Primary completion24 Dec 2025
  4. Study completion24 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
194 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05316311
Sponsor's protocol ID
CNV202003
Other IDs
CNV202003
Status last verified
Aug 2026
First submitted
30 Mar 2022
Last updated
7 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: 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

Publications

  • Redon J, Olsen MH, Cooper RS, Zurriaga O, Martinez-Beneito MA, Laurent S, Cifkova R, Coca A, Mancia G. Stroke mortality and trends from 1990 to 2006 in 39 countries from Europe and Central Asia: implications for control of high blood pressure. Eur Heart J. 2011 Jun;32(11):1424-31. doi: 10.1093/eurheartj/ehr045. Epub 2011 Apr 12.

    PubMed 21487117

  • Wong KS, Li H, Lam WW, Chan YL, Kay R. Progression of middle cerebral artery occlusive disease and its relationship with further vascular events after stroke. Stroke. 2002 Feb;33(2):532-6. doi: 10.1161/hs0202.102602.

    PubMed 11823665

  • Kasner SE, Chimowitz MI, Lynn MJ, Howlett-Smith H, Stern BJ, Hertzberg VS, Frankel MR, Levine SR, Chaturvedi S, Benesch CG, Sila CA, Jovin TG, Romano JG, Cloft HJ; Warfarin Aspirin Symptomatic Intracranial Disease Trial Investigators. Predictors of ischemic stroke in the territory of a symptomatic intracranial arterial stenosis. Circulation. 2006 Jan 31;113(4):555-63. doi: 10.1161/CIRCULATIONAHA.105.578229. Epub 2006 Jan 23.

    PubMed 16432056

  • Famakin BM, Chimowitz MI, Lynn MJ, Stern BJ, George MG; WASID Trial Investigators. Causes and severity of ischemic stroke in patients with symptomatic intracranial arterial stenosis. Stroke. 2009 Jun;40(6):1999-2003. doi: 10.1161/STROKEAHA.108.546150. Epub 2009 Apr 30.

    PubMed 19407228

  • Fiorella D. Endovascular treatment of intracranial stenosis. World Neurosurg. 2011 Dec;76(6 Suppl):S66-70. doi: 10.1016/j.wneu.2011.07.024.

    PubMed 22182273

  • Bose A, Hartmann M, Henkes H, Liu HM, Teng MM, Szikora I, Berlis A, Reul J, Yu SC, Forsting M, Lui M, Lim W, Sit SP. A novel, self-expanding, nitinol stent in medically refractory intracranial atherosclerotic stenoses: the Wingspan study. Stroke. 2007 May;38(5):1531-7. doi: 10.1161/STROKEAHA.106.477711. Epub 2007 Mar 29.

    PubMed 17395864

  • Zaidat OO, Klucznik R, Alexander MJ, Chaloupka J, Lutsep H, Barnwell S, Mawad M, Lane B, Lynn MJ, Chimowitz M; NIH Multi-center Wingspan Intracranial Stent Registry Study Group. The NIH registry on use of the Wingspan stent for symptomatic 70-99% intracranial arterial stenosis. Neurology. 2008 Apr 22;70(17):1518-24. doi: 10.1212/01.wnl.0000306308.08229.a3. Epub 2008 Jan 30.

    PubMed 18235078

  • Fiorella DJ, Turk AS, Levy EI, Pride GL Jr, Woo HH, Albuquerque FC, Welch BG, Niemann DB, Aagaard-Kienitz B, Rasmussen PA, Hopkins LN, Masaryk TJ, McDougall CG. U.S. Wingspan Registry: 12-month follow-up results. Stroke. 2011 Jul;42(7):1976-81. doi: 10.1161/STROKEAHA.111.613877. Epub 2011 Jun 2.

    PubMed 21636812

  • Barnard ZR, Alexander MJ. Update in the treatment of intracranial atherosclerotic disease. Stroke Vasc Neurol. 2019 Oct 16;5(1):59-64. doi: 10.1136/svn-2019-000279. eCollection 2020.

    PubMed 32411409

  • Nordmeyer H, Chapot R, Haage P. Endovascular Treatment of Intracranial Atherosclerotic Stenosis. Rofo. 2019 Jul;191(7):643-652. doi: 10.1055/a-0855-4298. Epub 2019 Apr 4. English, German.

    PubMed 30947351

  • Tarabishy (2019). Counseling and Management of Patients with Intracranial Atherosclerosis Disease. In: Spiotta A., Turner R., Chaudry M., Turk A. (eds) Management of Cerebrovascular Disorders.

  • 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.

    PubMed 32453401

  • 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.

    PubMed 28017227

  • 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.

    PubMed 32270364

  • Samuels OB, Joseph GJ, Lynn MJ, Smith HA, Chimowitz MI. A standardized method for measuring intracranial arterial stenosis. AJNR Am J Neuroradiol. 2000 Apr;21(4):643-6.

    PubMed 10782772

Questions about this trial

What is this clinical trial studying?

A study testing CERENOVUS ENTERPRISE 2 Intracranial Stent in people with Intracranial Atherosclerosis, run by Medos International SARL at 14 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants with In-Stent Restenosis (time frame: At 12 months post-procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05316311, which also lists 29 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.

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