Balloon Angioplasty for Symptomatic Intracranial Artery Stenosis (BASIS)

  • STATUS
    Recruiting
  • End date
    May 24, 2025
  • participants needed
    512
  • sponsor
    Ministry of Science and Technology of the People´s Republic of China
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Updated on 24 April 2022
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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 care with aggressive medical care 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, parallel controlled trial.

Description

This trial is a multicenter，prospective, randomized, parallel controlled trial. A total of approximately 512 patients (35-80 years of age) who suffered from TIA/nondisabled stroke due to 70-99% of the stenosis of one major intracranial artery (including anterior circulation and posterior circulation) during more than 14 days before the screening period 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 care which is the same as the control group; 2) Control group will receive aggressive medical care only. Aggressive medical care 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 130-140/90-100 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 care 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 care, 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 29 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 Institutional Review Board (IRB) and Ethics Committee(EC) in Being Tiantan hospital, Capital Medical University.

Details
Condition Intracranial Artery Stenosis
Treatment intracranial balloon angioplasty
Clinical Study IdentifierNCT03703635
SponsorMinistry of Science and Technology of the People´s Republic of China
Last Modified on24 April 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Males or females between 35 and 80 years of age
Subjects with primary or recurrent symptomatic intracranial arteriosclerosis (stroke or transient ischemic attack within 21 days before enrollment, with at least one antithrombotic drug and/or vascular risk factors controlled)
Confirmed by DSA: a major intracranial artery (including anterior and posterior circulation, the anterior and posterior circulation lesions include: the terminal internal carotid artery (segments C4-C7), the M1 segment of the middle cerebral artery, the V4 segment of the vertebral artery, and the basilar artery) stenosis between 70% and 99%, (measured by WASID method), and corresponding to clinical symptoms; lesion length≤10mm, diameter≥1.5mm, and the distal blood vessel is normal. (For the curvature and angle of the lesion, the investigator decides whether it is included in the study according to the actual situation of the Subject)
Those who voluntarily participate in the study and sign informed consent form

Exclusion Criteria

Those who have surgery within 30 days or plan to perform major surgery within 90 days (surgery grade 3 and above)
Those who received thrombolytic therapy within 24 hours before enrollment
Those with increased neurological symptoms within 24 hours before enrollment
Subjects of acute ischemic stroke within 2 weeks before enrollment
In addition to the target vessel and main blood supply artery, there are other intracranial artery stenosis more than 70%
When there is a stenosis in the main blood supply artery of the target vessel, the stenosis should be excluded by more than 50%. For example, when the lesion is located in the middle cerebral artery, the ipsilateral internal carotid artery stenosis should be excluded by >50%; when the lesion is located in the basilar artery, the dominant side vertebral artery stenosis >50% should be excluded; non-responsible vascular extracranial artery more than 70% should be excluded; Balanced vertebral artery stenosis, if there is >70% stenosis in the contralateral vertebral artery at the same time, it should be excluded (because it is impossible to determine which side is the responsible vessel, and the contralateral stenosis also has a potential risk of vascular events.). The following are not exclusions: contralateral vertebral artery terminates posteroinferior cerebellar artery (PICA), dysplasia or slender, and contralateral vertebral artery is dominant vertebral artery
The subjects with tandem lesions or stroke due to perforator artery occlusion
The mRS baseline score of disabling stroke is more than 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)
The target vessel is severely calcified and closely related to stenosis
It is suspected that the ischemic event is due to embolism or arterial embolism from the extracranial segment (including ipsilateral chest or neck vascular occlusive disease) or potential cardiogenic embolism (e.g. atrial fibrillation, mitral stenosis, patent foramen ovale, left ventricular thrombus, myocardial infarction within 6 weeks, etc.)
There are intracranial tumors, aneurysms or intracranial arteriovenous malformations
Intracranial hemorrhage within the past 3 months, including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, epidural hemorrhage and subdural hemorrhage, etc
Those who are allergic to heparin, aspirin, clopidogrel, contrast agents, anesthetics, and balloon components
Severe liver and kidney dysfunction, ALT is more than 3 times normal value upper limit or AST is more than 3 times normal value upper limit, serum creatinine increased more than 2 times normal value upper limit
Pregnant and lactating women
The survival expectation is less than 1 year
Those who are unable to complete follow-up because of mental illness, cognitive or emotional disorders
Hemoglobin is lower than 100g/L, platelet count is less than 100×109/ L, international normalized ratio (INR) is more than 1.5 (irreversible), coagulation disorders or uncorrectable bleeding factors
All subjects who are participating in other drug/medical device clinical trials and have not completed the programme requirements
An angioplasty procedure (including balloon dilatation, stenting, or endarterectomy) in a previous target vessel or its primary blood supply artery, or a planned stenting procedure
Those who cannot receive dual antiplatelet therapy because of other dieases
Vascular tortousity cannot stabilize the establishment of vascular access
Subjects with renal artery, radial artery, and cardiac coronary artery requiring concurrent intervention
Subjects who, in the opinion of the investigators, should not participate in the study
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