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Intracranial Artery StenosisBASISNCT03703635

Balloon Angioplasty for Symptomatic Intracranial Artery Stenosis

A study testing intracranial balloon angioplasty and aggressive medical management in people with Intracranial Artery Stenosis, run by Ministry of Science and Technology of the People´s Republic of China at 31 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Intracranial atherosclerotic disease (ICAD) is the most common cause of ischemical cerebrovascular events. The risk of stroke recurrence or death of ICAD patients remains very high. Read more about this study

Who is it for?
Ages 35 to 80 years
Conditions the study is for
Intracranial Artery Stenosis
What is being tested?
intracranial balloon angioplasty and aggressive medical management
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
512 participants
Where
31 sitesChina
Study dates
17 Oct 2018to May 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 35 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 35-80 years.
  • Participants with primary or recurrent sICAS (a recent TIA[<90 days] or ischemic stroke [14-90 days] before enrollment attributed to 70-99% atherosclerotic stenosis of a major intracranial artery) receiving treatment with at least one antithrombotic drug and/or standard medical management of vascular risk factors;
  • Diagnosed by DSA: a major intracranial artery (terminal internal carotid artery [ICA] [C4-C7 segments], middle cerebral artery [MCA] M1 segment, vertebral artery [VA] V4 segment, and basilar artery [BA]) severe atherosclerotic stenosis (70-90% according to WASID method) with lesion length ≤ 10mm, diameter ≥1.5mm, and normal distal artery. (Regarding the curvature and angle of the lesion, whether the patient is enrolled in BASIS per the investigator's determination based on the patient's situation);
  • Informed consent signed.

Who cannot join

  • Surgery within the past 30 days or plan to receive ≥ 3-grade surgery within 90 days;
  • Thrombolytic therapy within 24 hours before enrollment;
  • Neurological deficits worsen within 24 hours before enrollment;
  • Acute ischemic stroke onset within 14 days before enrollment;
  • Other intracranial arteries with severe stenosis (70-99%) besides the target artery and its supplying artery;
  • Target artery's supplying artery stenosis > 50%. For example, patient with MCA severe stenosis (target artery) and the ipsilateral ICA stenosis > 50% should be excluded; patient with BA severe stenosis (target artery) and the dominant VA stenosis > 50% should be excluded; the patient with extracranial artery (non-lesion side) stenosis > 70% should be excluded; For patients with balanced VA, if bilateral VA stenosis > 70% at the same time, should be excluded (unable to determine which VA is the lesion artery). However, if patient's dominant VA is the lesion artery with a dysplasia or slender contralateral VA or a non-dominant contralateral VA terminating at posteroinferior cerebellar artery, should not be excluded.
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  • Participant with perforator stroke (except for severe stenosis of supplying artery combined with hemodynamic compromise or poor collaterals) 12;
  • Baseline modified Rankin Scale ≥ 3;
  • Non-atherosclerotic diseases (e.g., arterial dissection, moyamoya disease, vascular inflammatory lesions caused by infection, autoimmune diseases, post-irradiation, postpartum status; developmental or genetic abnormalities such as fibromuscular dysplasia, sickle cell anemia, suspected vasospasm);
  • Target artery with severely calcified and adjacent to stenosis;
  • Suspected ischemic event caused by embolism or the arterial embolism from extracranial segment (ipsilateral chest or neck vascular occlusive disease) or potential cardioembolism (e.g., atrial fibrillation, mitral stenosis, patent foramen ovale, left ventricular thrombus, myocardial infarction within 6 weeks, etc.);
  • Coexistent with Intracranial tumors, aneurysms or intracranial arteriovenous malformations;
  • Intracranial hemorrhage within the past 3 months, including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, epidural hemorrhage or subdural hemorrhage, etc.;
  • Angioplasty procedure (including balloon dilatation, stenting, or endarterectomy) performed at the original target vessel or its primary supplying artery, or a planned stenting procedure;
  • Unable to receive dual antiplatelet therapy due to other diseases;
  • Tortuous vascular approach that cannot be stabilized to obtain vascular access;
  • Allergic to heparin, aspirin, clopidogrel, contrast agents, anesthetics, and balloon components;
  • Hemoglobin < 100g/L, platelet count < 100×109/ L, international normalized ratio (INR) >1.5 (irreversible), Coagulation dysfunction or uncorrectable bleeding factors;
  • Severe liver or kidney dysfunction. ALT > three-fold higher than the upper limit of normal value or AST > three-fold higher than the upper limit of normal value, or serum creatinine > two-fold higher than the upper limit of normal value;
  • Pregnant and lactating women;
  • Participants with renal artery, radial artery, and cardiac coronary artery requiring concurrent intervention;
  • Expected survival expectation is less than< 1 year;
  • Unable to complete follow-up due to mental illness, cognitive or emotional disorders;
  • Participants participating in other drug/medical device clinical trials who have not yet completed the program requirements;
  • Participants are not suitable for BASIS trial per investigator's opinion.

Trial locations and contacts

31 sites in 1 country.

31 sites in 1 country

China31 sites

  • Beijing Chao-Yang Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100020

  • Beijing Fengtai You Anmen Hospital

    Beijing, Beijing Municipality, 100069

  • Beijing Tian Tan Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100070

  • Dongfang Hospital Beijing University of Chinese Medicine

    Beijing, Beijing Municipality, 100078

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100853

  • Beijing Luhe Hospital,Capital Medical University

    Beijing, Beijing Municipality, 101149

  • Beijing ShunYi Hospital

    Beijing, Beijing Municipality, 101300

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • Hunan Provincial People's Hospital

    Changsha, Hunan, 410005

  • The First People's Hospital of Changzhou

    Changzhou, Jiangsu, 213003

  • West China Hospital Sichuan University

    Chengdu, Sichuan, 610041

  • The First Affiliated Hospital,Sun Yat-sen University

    Guangzhou, Guangdong, 510080

  • Guangdong Provincial Hospital of Traditional Chinese Medicine

    Guangzhou, Guangdong, 510120

  • The Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510260

  • Guangdong Sanjiu Brain Hospital

    Guangzhou, Guangdong, 510510

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou, 550004

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230022

  • The First Affiliated Hospital of Anhui University of CM

    Hefei, Anhui, 230031

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

  • Shandong Provincial Hospital

    Jinan, Shandong, 250021

  • LiaochengI People's Hospital

    Liaocheng, Shandong, 252000

  • Jiangxi Provincial People's Hospital

    Nanchang, Jiangxi, 330006

  • Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School

    Nanjing, Jiangsu, 210008

  • The Second Affiliated Hospital Of NanJing Medical University

    Nanjing, Jiangsu, 210008

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266000

  • General Hospital of The Northern Theater of The Chinese People's Liberation Army

    Shenyang, Liaoning, 110015

  • Shenzhen Hospital of Southern Medical University

    Shenzhen, Guangdong, 518110

  • Wuhan NO.1 Hospital

    Wuhan, Hubei, 430022

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi, 710061

  • The Affiliated Hospital of Northwest University

    Xian, Shanxi, 100005

  • Henan Provincial People's Hospital

    Zhengzhou, Henan, 450003

Other trials in China

About this study

Official title: A Multicenter, Prospective, Randomized, Open-label, Blinded End-point Clinical Study to Evaluate the Safety and Efficacy of Intracranial Balloon Angioplasty Plus Aggressive Medical Management for Symptomatic Intracranial Artery Stenosis

Intracranial atherosclerotic disease (ICAD) is the most common cause of ischemical cerebrovascular events. The risk of stroke recurrence or death of ICAD patients remains very high. Even with aggressive medical management including dual antiplatelet therapy and strict management of risk factors, 12.2 percent of patients with 70-99 percent stenosis of intracranial artery had stroke or death during 1 year follow-up. In the real world, the 30-day risk of recurrent stroke of patients with aggressive medical management was as high as 20.2 percent. Balloon angioplasty and stent for intracranial artery have become important alternative treatments to prevent recurrent stroke for patients with severe intracranial atherosclerotic stenosis. Nevertheless, the SAMMPRIS trial has suggested intracranial stenting has higher stroke and death rate than aggressive medication with high peri-procedure complication rate. Previous nonrandomized studies have showed that stroke and death rate of angioplasty for ICAD patients with severe stenosis of intracranial artery is lower than that of aggressive medication. The primary purpose of this trial is to compare intracranial angioplasty plus aggressive medical management with aggressive medical management alone for the treatment of patients with 70-99 percent intracranial artery stenosis because of ICAD and to clarify the efficacy and safety of intracranial angioplasty through a multicenter, prospective, randomized, open-label, blinded end-point trial.

Read the detailed description

This trial is a multicenter, prospective, randomized, parallel controlled trial. A total of approximately 512 patients (35-80 years of age) with primary or recurrent sICAS (a recent TIA[<90 days] or ischemic stroke [14-90 days] before enrollment attributed to 70-99% atherosclerotic stenosis of a major intracranial artery) receiving treatment with at least one antithrombotic drug and/or standard medical management of vascular risk factors will be enrolled. Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomized into two groups according to the 1:1 ratio after offering informed content: 1) Experimental group will receive intracranial angioplasty plus aggressive medical management which is the same as the control group; 2) Control group will receive aggressive medical management only. Aggressive medical management includes 100 mg/day of aspirin during the follow-up period; 75 mg/day of clopidogrel within 90 days after enrollment, and whether clopidogrel should continue to be used depends on the actual situation of the subjects; 20-80mg/day of atorvastatin should be used during the year after enrollment, and dose adjustment to target LDL <1.8mmol/L or <70 mg/dl. Both groups will receive risk factors management including blood pressure to maintain 130-140/80-90 mmHg and LDL lower than 70 mg/dl or 1.8mmol/L. The primary objective is to evaluate the safety and efficacy of intracranial angioplasty combined with aggressive medical management for symptomatic intracranial artery stenosis. The study consists of 11 visits including the day of screening and randomization, the day when the subject receive intracranial angioplasty and/or aggressive medical management, the day before the subject is discharged from hospital, 30, 90,180 days and 1 year after enrollment, and every half a year after then until the third year. Demographic information, symptoms and signs, laboratory test, neuro-imaging assessment neurological function rating scale will be recorded during the program. The trial is anticipated to last from October 2018 to May 2025 with 512 subjects recruited from 31 centers in China. All the related investigative organization and individuals will obey the Declaration of Helsinki and Chinese Good Clinical Practice standard. A Data and Safety Monitoring Board (DSMB) will regularly monitor safety during the study. The trial has been approved by the ethics committee of Beijing Tiantan Hospital and corresponding branch centers.

Being tested
intracranial balloon angioplasty, aggressive medical management
Keywords
ICAD, Intracranial Artery Stenosis, Ischemic Stroke, TIA, Angioplasty, Aggressive Medical Care
Medical subject headings
Ischemic Stroke

What participants receive

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

  • intracranial balloon angioplastyDevice

    A balloon (recommending the Neuro RX and Neuro LPS Intracranial Balloon Dilation Catheter [Sinomed Inc., Tianjin, China]) is navigated by the microwire to the lesion of the target artery.

  • aggressive medical managementDrug

    Aspirin 100mg once/day during the follow-up period, Clopidogrel 75mg once/day for at least 90 days, Atorvastatin 20-80mg once/day as the situation requires and risk factors management including blood pressure to maintain 130-140/80-90 mmHg and LDL lower than 70 mg/dl or 1.8mmol/L.

Study groups in NCT03703635
Study groupRoleWhat they receive
Intracranial balloon angioplasty and aggressive medical managementExperimentalAll the participants in this group will be given Intracranial balloon angioplasty and aggressive medical management.
Receives: Device: intracranial balloon angioplasty; Drug: aggressive medical management
Aggressive Medical managementExperimentalAll the participants in this group will be given aggressive medical management alone.
Receives: Drug: aggressive medical management

What is being measured

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

  1. Stroke or death within 30 days after enrollment or after balloon angioplasty procedure of the qualifying lesion during follow-up, or any ischemic stroke or revascularization from the qualifying artery beyond 30 days through 12 months after enrollment

    This outcome includes ischemic/hemorrhagic stroke and all-cause death within 30 days after enrollment or after balloon angioplasty procedure of the qualifying lesion during follow-up, or any ischemic stroke and revascularization from the original culprit symptomatic intracranial artery beyond 30 days through 12 months after enrollment.

    Measured: 12 months

Secondary outcomes (19)

  1. Any stroke (ischemic or hemorrhage stroke) or all-cause deaths within 30 days after enrollment or after balloon angioplasty procedure of the qualifying lesion during follow-up

    Any stroke (ischemic or hemorrhage stroke) or all-cause deaths within 30 days after enrollment or after balloon. angioplasty procedure of the qualifying lesion during follow-up.

    Measured: 30 days

  2. Any stroke (ischemic or hemorrhage stroke) inside of the territory of the target artery or all-cause deaths within 90 days after enrollment

    Rat of any stroke (ischemic or hemorrhage stroke) inside of the territory of the target artery or all-cause deaths within 90 days after enrollment.

    Measured: 90 days

  3. Any stroke (ischemic or hemorrhage stroke) outside of the territory of the target artery within 90 days after enrollment

    Rat of any stroke (ischemic or hemorrhage stroke) outside of the territory of the target artery within 90 days after enrollment.

    Measured: 90 days

  4. Neurological improvement assessed by mRS at 90 days

    Modified Rankin Scale (mRS score) ranged from 0 to 6 is used to measure the recovery of neurological function in patients after stroke. Score 0 means completely no symptom. Score 6 means death. Higher values represent a worse outcome.

    Measured: 90 days

  5. Any stroke (ischemic or hemorrhage stroke) inside of the territory of the target artery or all-cause deaths within 12 months after enrollment

    Rat of any stroke (ischemic or hemorrhage stroke) inside of the territory of the target artery or all-cause deaths within 12 months after enrollment.

    Measured: 12 months

  6. Revascularization of the target artery within 12 months after enrollment

    Rat of revascularization of the target artery within 12 months after enrollment.

    Measured: 12 months

  7. Any stroke (ischemic or hemorrhage stroke) outside of the territory of the target artery within 12 months after enrollment

    Rat of any stroke (ischemic or hemorrhage stroke) outside of the territory of the target artery within 12 months after enrollment.

    Measured: 12 months

  8. Neurological improvement assessed by mRS at 12 months

    Modified Rankin Scale (mRS score) ranged from 0 to 6 is used to measure the recovery of neurological function in patients after stroke. Score 0 means completely no symptom. Score 6 means death. Higher values represent a worse outcome.

    Measured: 12 months

  9. Restenosis rate of the target artery within 12 months (defined as rate of stenosis >70% or increased by 30% based on following-up neurovascular imaging)

    Restenosis is defined as rate of stenosis >70% or increased by 30% based on following-up neurovascular imaging.

    Measured: 12 months

  10. Combined events such as stroke, myocardial infarction, and vascular death within 12 months after enrollment

    Combined events include stroke, myocardial infarction and vascular death etc; Myocardial infarction occurs when blood stops flowing properly to a part of the heart, and the heart muscle is injured because it is not receiving enough oxygen; vascular death means the death is due to vessel rupture or clot.

    Measured: 12 months

  11. Life quality assessment (EuroQol-5-Dimensions Scale [EQ-5D] questionnaire) within 12 months after enrollment

    Quality of life evaluated by EuroQol-5-Dimensions Scale (EQ-5D) questionnaire at the 12 months follow-up. EQ-5D descriptive system covers five dimensions including mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has three response levels (no problem, some problems, and severe problems). The EQ-5D descriptive system generates 243 health states, each of which was assigned a utility. score ranging from -0.59 to 1.00 (full health)

    Measured: 12 months

  12. Any stroke (ischemic or hemorrhage stroke) inside of the territory of the target artery or all-cause deaths within 24 months after enrollment

    Rat of any stroke (ischemic or hemorrhage stroke) inside of the territory of the target artery or all-cause deaths within 24 months after enrollment.

    Measured: 24 months

  13. Any stroke (ischemic or hemorrhage stroke) outside of the territory of the target artery within 24 months after enrollment

    Rat of any stroke (ischemic or hemorrhage stroke) outside of the territory of the target artery within 24 months after enrollment.

    Measured: 24 months

  14. Neurological improvement assessed by mRS at 24 months

    Modified Rankin Scale (mRS score) ranged from 0 to 6 is used to measure the recovery of neurological function in patients after stroke. Score 0 means completely no symptom. Score 6 means death. Higher values represent a worse outcome.

    Measured: 24 months

  15. Combined events such as stroke, myocardial infarction, and vascular death within 24 months after enrollment

    Combined events include stroke, myocardial infarction and vascular death etc; Myocardial infarction occurs when blood stops flowing properly to a part of the heart, and the heart muscle is injured because it is not receiving enough oxygen; vascular death means the death is due to vessel rupture or clot.

    Measured: 24 months

  16. Any stroke (ischemic or hemorrhage stroke) inside of the territory of the target artery or all-cause deaths within 36 months after enrollment

    Rat of any stroke (ischemic or hemorrhage stroke) inside of the territory of the target artery or all-cause deaths within 36 months after enrollment.

    Measured: 36 months

  17. Any stroke (ischemic or hemorrhage stroke) outside of the territory of the target artery within 36 months after enrollment

    Rat of any stroke (ischemic or hemorrhage stroke) outside of the territory of the target artery or all-cause deaths within 36 months after enrollment.

    Measured: 36 months

  18. Neurological improvement assessed by mRS at 36 months

    Modified Rankin Scale (mRS score) ranged from 0 to 6 is used to measure the recovery of neurological function in patients after stroke. Score 0 means completely no symptom. Score 6 means death. Higher values represent a worse outcome.

    Measured: 36 months

  19. Combined events such as stroke, myocardial infarction, and vascular death within 36 months after enrollment

    Combined events include stroke, myocardial infarction and vascular death etc; Myocardial infarction occurs when blood stops flowing properly to a part of the heart, and the heart muscle is injured because it is not receiving enough oxygen; vascular death means the death is due to vessel rupture or clot.

    Measured: 36 months

Timeline

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

  1. First posted12 Oct 2018
  2. Study start17 Oct 2018
  3. Primary completion2 May 2023
  4. Study completionMay 2025 (estimated)

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
512 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03703635
Sponsor's protocol ID
2017YFC1307900
Acronym
BASIS
Status last verified
Jun 2023
First submitted
30 Sep 2018
Last updated
3 Jul 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Sun X, Deng Y, Zhang Y, Yang M, Sun D, Nguyen TN, Tong X, Peng G, Liu A, Xu Y, Wu Y, Geng X, Wang Y, Li T, Xing S, Wu W, Ji Y, Yang H, Wang S, Gao X, Yang W, Zhao X, Liu L, Ma N, Gao F, Mo D, Huo X, Song L, Li X, Zhang J, He H, Lv M, Mu S, Yu W, Liebeskind DS, Amin-Hanjani S, Wang Y, Wang Y, Miao Z; BASIS Investigators. Balloon Angioplasty vs Medical Management for Intracranial Artery Stenosis: The BASIS Randomized Clinical Trial. JAMA. 2024 Oct 1;332(13):1059-1069. doi: 10.1001/jama.2024.12829.

    PubMed 39235816

  • Sun X, Yang M, Sun D, Peng G, Deng Y, Zhao X, Liu L, Ma N, Gao F, Mo D, Yu W, Wang Y, Wang Y, Miao Z. Balloon Angioplasty for Symptomatic Intracranial Artery Stenosis (BASIS): protocol of a prospective, multicentre, randomised, controlled trial. Stroke Vasc Neurol. 2024 Feb 27;9(1):66-74. doi: 10.1136/svn-2022-002288.

    PubMed 37202152

Questions about this trial

What is this clinical trial studying?

A study testing intracranial balloon angioplasty and aggressive medical management in people with Intracranial Artery Stenosis, run by Ministry of Science and Technology of the People´s Republic of China at 31 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 4 inclusion and 25 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: status not confirmed, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 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?

Results are not available in the source record.

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?

Stroke or death within 30 days after enrollment or after balloon angioplasty procedure of the qualifying lesion during follow-up, or any ischemic stroke or revascularization from the qualifying artery beyond 30 days through 12 months after enrollment (time frame: 12 months). 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 NCT03703635, which also lists 2 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 3 Jul 2023.

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