Balloon Angioplasty for Symptomatic Intracranial Artery Stenosis

NCT03703635 | Unknown DMC

• 1 other identifier: 2017YFC1307900
• Study Type: interventional
• Target: 512
• Locations: 1 country
• Sites: 31

Brief 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. 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.

Conditions

Intracranial Artery Stenosis

Keywords

ICAD; Intracranial Artery Stenosis; Ischemic Stroke; TIA; Angioplasty; Aggressive Medical Care

Outcome Measures

Primary Outcomes (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.

  12 months

Secondary Outcomes (19)

• 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

  30 days

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

  90 days

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

  90 days

• Neurological improvement assessed by mRS at 90 days

  90 days

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

  12 months

Study Arms (2)

Intracranial balloon angioplasty and aggressive medical management

EXPERIMENTAL

All the participants in this group will be given Intracranial balloon angioplasty and aggressive medical management.

Device: intracranial balloon angioplasty; Drug: aggressive medical management

Aggressive Medical management

EXPERIMENTAL

All the participants in this group will be given aggressive medical management alone.

Drug: aggressive medical management

Interventions

intracranial balloon angioplasty DEVICE

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.

Intracranial balloon angioplasty and aggressive medical management

aggressive medical management DRUG

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.

Aggressive Medical management; Intracranial balloon angioplasty and aggressive medical management

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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;

Sponsors & Collaborators

• Ministry of Science and Technology of the People´s Republic of China: lead

Study Sites (31)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230022, China

Location

The First Affiliated Hospital of Anhui University of CM

Hefei, Anhui, 230031, China

Location

Beijing Chao-Yang Hospital, Capital Medical University

Beijing, Beijing Municipality, 100020, China

Location

Beijing Fengtai You Anmen Hospital

Beijing, Beijing Municipality, 100069, China

Location

Beijing Tian Tan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

Location

Dongfang Hospital Beijing University of Chinese Medicine

Beijing, Beijing Municipality, 100078, China

Location

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

Beijing Luhe Hospital,Capital Medical University

Beijing, Beijing Municipality, 101149, China

Location

Beijing ShunYi Hospital

Beijing, Beijing Municipality, 101300, China

Location

The First Affiliated Hospital,Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

Guangdong Provincial Hospital of Traditional Chinese Medicine

Guangzhou, Guangdong, 510120, China

Location

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

Location

Guangdong Sanjiu Brain Hospital

Guangzhou, Guangdong, 510510, China

Location

Shenzhen Hospital of Southern Medical University

Shenzhen, Guangdong, 518110, China

Location

The Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, 550004, China

Location

Henan Provincial People's Hospital

Zhengzhou, Henan, 450003, China

Location

Wuhan NO.1 Hospital

Wuhan, Hubei, 430022, China

Location

Hunan Provincial People's Hospital

Changsha, Hunan, 410005, China

Location

The First People's Hospital of Changzhou

Changzhou, Jiangsu, 213003, China

Location

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

Nanjing, Jiangsu, 210008, China

Location

The Second Affiliated Hospital Of NanJing Medical University

Nanjing, Jiangsu, 210008, China

Location

Jiangxi Provincial People's Hospital

Nanchang, Jiangxi, 330006, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

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

Shenyang, Liaoning, 110015, China

Location

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location

Shandong Provincial Hospital

Jinan, Shandong, 250021, China

Location

LiaochengI People's Hospital

Liaocheng, Shandong, 252000, China

Location

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266000, China

Location

The Affiliated Hospital of Northwest University

Xian, Shanxi, 100005, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, 710061, China

Location

West China Hospital Sichuan University

Chengdu, Sichuan, 610041, China

Location

Related Publications (2)

• 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.

  PMID: 39235816 DERIVED

• 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.

  PMID: 37202152 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Zhongrong Miao, MD

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

• Yilong Wang, MD

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Departments of Interventional Neuroradiology, Beijing Tian Tan Hospital

Study Record Dates

• First Submitted: September 30, 2018
• First Posted: October 12, 2018
• Study Start: October 17, 2018
• Primary Completion: May 2, 2023
• Study Completion: May 1, 2025
• Last Updated: July 3, 2023

Record last verified: 2023-06

Locations

CN (31)