New stent shows promise for blocked brain arteries
NCT ID NCT05316311
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 Hide 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.
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.
- Detailed MRI scans could reveal which brain plaques trigger strokes
- After stroke, a balloon or a stent? trial tests which rescue opens blocked brain arteries better
- Can a Cholesterol-Lowering shot reverse brain artery blockages?
- New MRI technique could help predict strokes in High-Risk patients
- New drug combo aims to stop repeat strokes in High-Risk patients
- New brain stent aims to stop strokes in High-Risk patients