Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New stent shows promise for blocked brain arteries

NCT ID NCT05316311

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 07, 2026 · Updated 2 times

Summary

This study tested a special stent designed to open severely narrowed brain arteries in 194 people with symptomatic intracranial atherosclerosis. The goal was to see if the stent is safe and effective at keeping arteries open for at least 12 months. Researchers measured how often the artery narrowed again inside the stent and whether the procedure was technically successful.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CERENOVUS ENTERPRISE 2 intracranial stent
What this could lead to
If successful, this stent could offer a safe way to reopen blocked brain arteries and reduce stroke risk in high-risk patients.
What could go wrong
This was a single-arm study without a comparison group, so results may not prove the stent is better than standard care. The stent may also narrow again over time.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

194 people

The number who actually took part.

Started

May 2022

Finished

Dec 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

22 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Intracranial atherosclerosis are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

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

    Jinan, China

  • First Affiliated Hospital, Harbin Medical University

    Harbin, China

  • Haikou People's Hospital

    Haikou, China

  • Huashan Hospital Fudan University

    Shanghai, China

  • Nanjing Drum Tower Hospital

    Nanjing, China

  • Ningbo First Hospital

    Ningbo, China

  • Qilu Hospital of Shandong University

    Jinan, China

  • Shandong Provincial Hospital

    Jinan, China

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, China

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, China

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, China

  • Wenzhou Central Hospital

    Wenzhou, China

  • West China Hospital of Sichuan University

    Chengdu, China

  • Xuanwu Hospital, Capital Medical University

    Beijing, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.