An observational study in Intracranial Arteriosclerosis, Ischemic Preconditioning and Endovascular Procedures, sponsored by Tianjin Huanhu Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-16.
Sponsored by Tianjin Huanhu Hospital · Observational
Among 44 studies in Intracranial Arteriosclerosis with a site in China — 28 open to participants now, 28 under way, 2 of them phase 3. Intracranial Arteriosclerosis · China.
Among the 44 studies in Intracranial Arteriosclerosis with a site in China, this one is the 13th largest by planned enrollment of the 17 observational ones that give a count, is one of 9 that started in 2023, is one of 17 observational ones, reaches primary completion later than 10 of the 27 other live ones, and was the 23rd registered.
102 studies on the registry are indexed under Intracranial Arteriosclerosis; 48 are open to participants now.
Browse Intracranial Arteriosclerosis studies →28 of the 44 studies in Intracranial Arteriosclerosis with a site in China are open now. Recruiting first, the newest first:
Xuanwu Hospital, Beijing · Sites in China
Ages 18–80
Peking Union Medical College Hospital · Sites in China
Ages 18–80
Xuanwu Hospital, Beijing · Sites in China
Ages 18+ · Healthy volunteers
Qianfoshan Hospital · Sites in China
Ages 18–80
Fujian Medical University Union Hospital · Sites in China
Ages 18+
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 28 Intracranial Arteriosclerosis studies recruiting now, 11 (39%) set no upper age limit and 1 (4%) stops at 75 or younger; none take children under 18; 2 take healthy volunteers.
This study: 18 Years and older · all sexes.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
44 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 1 · Phase 3 3 · Phase 4 8
First in 2007; this study’s year is marked. 9 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 160 is below the median of 200 across 35 observational studies indexed under Intracranial Arteriosclerosis.
Median enrollment 200 across the 27 interventional studies, 300 across the 17 observational. Of the 7 that completed or were terminated, 0 (0%) have results posted.
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11 of 44 have an industry lead sponsor. The 10 most frequent:
Tianjin Huanhu Hospital is the lead sponsor of 26 studies on the registry; 20 are open to participants now.
Tianjin Huanhu Hospital has 1 study filed under Intracranial Arteriosclerosis — fewer than ten, so there is no comparison to draw.
6 of the studies in Intracranial Arteriosclerosis with a site in China that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06925971Phase 3MicroPort NeuroTech Co., Ltd.A Randomized Trial of the Rapamycin Target Eluting Stent for the Treatment of Symptomatic Cerebral Artery Atherosclerotic Disease（TARGET-DREAM） | 2027-10-01 |
| NCT07445581Jinggang Xia, MDTanhuo Decoction for Acute Coronary Syndrome With Cerebral Atherosclerosis in Elderly Patients | 2026-12-31 |
| NCT06881420Fujian Medical University Union HospitalBASIS Technique for Endovascular Therapy of Acute Large Vessel Occlusion Strokes Due to Intracranial Atherosclerotic Disease | 2026-12-31 |
| NCT05550077jiaoliqunOptical Coherence Tomography for Intracranial Atherosclerotic Stenosis | 2026-12-31 |
| NCT07927569Qianfoshan HospitalIntegrated PET/MR Assessment of Brain Recovery After Recanalization of Non-Acute Atherosclerotic MCA Occlusion | 2027-01-01 |
Add all 6 to your calendar (.ics) → With an account.
Among the 44 studies in Intracranial Arteriosclerosis with a site in China, from their registry updates:
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The purpose of this registry is to evaluate the safety and efficacy of RIC for patients with symptomatic intracranial atherosclerotic stenosis (sICAS) undergoing endovascular therapy.
Intracranial atherosclerotic stenosis (ICAS) is one of the leading causes of ischemic stroke, and its incidence varies widely among different ethnic groups. ICAS may represent approximately 10% of ischemic stroke in Caucasians and even be responsible for up to 50% in Chinese population. Recurrent stroke risks are as high as 23% 1 year after transient ischemic stroke (TIA) or stroke in patients with a stenosis of 70% or more. The Chinese IntraCranial AtheroSclerosis (CICAS) study indicated the prevalence of ICAS was 46.6%; Patients with ICAS had more severe stroke at admission and stayed longer in hospitals compared with those without intracranial stenosis. After 12 months, recurrent stroke occurred in 3.27% of patients with no stenosis, in 3.82% for those with 50% to 69% stenosis, in 5.16% for those with 70% to 99% stenosis, and in 7.27% for those with total occlusion.
Current guidelines recommend best medical treatment (BMM) for patients with sICAS, which contains antithrombotic therapy, management of vascular risk factor (diabetes, lipids, and especially hypertension) and patient behaviors modification (diet, exercise and smoking cessation). But, even with the intervention of BMM, the recurrence of ischemic stroke or transient ischemic attacks (TIAs) in patients with sICAS still cannot be reduced. Endovascular therapy with intracranial angioplasty and/or stenting holds great promise as a treatment for sICAS. A recent trial found that, compared with bare-metal stent, drug-eluting stent reduced the risks of In-stent restenosis and ischemic stroke recurrence in patients with sICAS. However, endovascular therapy for patients with sICAS is known to be associated with potentially serious complications such as cerebral hyper-perfusion syndrome, intracranial hemorrhage, embolism and In-stent restenosis, etc. Those are the main reasons that affect the effect of endovascular therapy, thus limiting its application and popularization to a great degree.
Remote Ischemic Conditioning (RIC) is one of the most potent neuroprotective approaches that can minimize neuronal damage by protecting against ischemia-reperfusion injury and promote neuronal recovery by stimulating endogenous protective mechanism through transiently occluding the blood supply to non-significant organs or tissues such as limbs. The investigators see a promising future for RIC in facilitating further clinical translation and application due to its unique features of safety, simplicity and non-invasiveness. In recent years, the safety and efficacy of RIC on stroke intervention has been confirmed by a series of basic and clinical researches, among which RIC in combination with adjuvant drug therapy for sICAS-induced ischemic stroke patient improve cerebral blood flow and reduce stroke recurrence. Since its safety and efficacy has been verified, RIC can also be used to reduce the risks of In-stent restenosis for patients with carotid stent implantation and has extensive application prospects for patients with severe acute ischemic stroke treated with endovascular thrombectomy.
There is not enough evidence as to provide any specific recommendation regarding the use of RIC in sICAS patients, But we speculate that RIC has a certain effect on preventing perioperative complications for patients with sICAS undergoing endovascular therapy. Therefore, we intend to conduct this prospective cohort study to shed light on the utility of this promising therapy.
This study prospectively collects data of patients with sICAS who receive endovascular therapy in the Comprehensive Neurovascular Ward of Tianjin Huanhu Hospital. Depending on their preference, patients enrolled in this registry will be divided into 2 groups, receiving either endovascular therapy alone or endovascular therapy plus RIC respectively.
This study prospectively collects data of patients with sICAS who receive endovascular therapy in the Comprehensive Neurovascular Ward of Tianjin Huanhu Hospital. Depending on their preference, patients enrolled in this registry will be divided into 2 groups, receiving either endovascular therapy alone or endovascular therapy plus RIC respectively.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
According to current guideline recommendations, patients enrolled in this cohort will receive standardized perioperative management, endovascular therapy, and postoperative medical therapy.
Patients enrolled in this cohort will receive the same treatment as those in the endovascular therapy alone cohort as well as additional remote ischemic conditioning treatment. Remote ischemic conditioning treatment protocol: RIC will be applied immediately after admission to the integrated neurovascular ward and the treatment continues until the patient is discharged, Once the patient is discharged, the choice of whether to continue RIC treatment depends on the patient's preference. RIC was induced through a standard blood pressure cuff placed around the non-paretic arm. The protocol includes 5 cycles of intermittent manually induced upper limb ischemia, alternating 5 minutes of inflation (20mmHg above systolic blood pressure), and 5 minutes of deflation twice a day.
Other: Remote Ischemic Conditioning
Remote ischaemic conditioning (RIC) refers to a process whereby periods of intermittent ischemia, typically via the cyclical application of a blood pressure cuff to a limb at above systolic pressure, confers systemic protection against ischemia in spatially distinct vascular territories.
The presence of ≥1 new brain lesions on DWI within 48 hours after endovascular stenting
A new brain lesion was diagnosed if increased signal intensity was visible on DWI with correspondent decreased signal on apparent diffusion coefficient.
Time frame: 48 hours
Incidence of clinical adverse events within 12 months after endovascular stenting
Clinical adverse events include ischemic stroke, TIA, acute myocardial infarction,hemorrhagic stroke, hyperperfusion syndrome, and death.
Time frame: 12 months
Number of new brain lesions on DWI within 48 hours after endovascular stenting
The number of new DWI lesions
Time frame: 48 hours
The volume of new brain lesions on DWI within 48 hours after endovascular stenting
The volume of single lesions, and volume of all lesions were measured on DWI.
Time frame: 48 hours
National Institutes of Health Stroke Scale (NIHSS) scores at 12 months
The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.
Time frame: 12 months
Modified Rankin Scale (mRS) scores at 12 months
The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms. 1. - No significant disability. Able to carry out all usual activities, despite some symptoms. 2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. - Moderate disability. Requires some help, but able to walk unassisted. 4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. - Dead.functional disability.
Time frame: 12 months
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Jan 2023; primary completion for Jan 2026, 36 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Intracranial Arteriosclerosis →
Tianjin Huanhu Hospital