Article Figures & Data
- Figure 1
The flowchart of BASIS trial. *Neurovascular imaging includes digital subtraction angiography (DSA), CT angiography (CTA) or magnetic resonance angiography (MRA). AMM, aggressive medical management; BA, basilar artery; BASIS, Balloon Angioplasty for Symptomatic Intracranial Artery Stenosis; ICA, internal carotid artery; MCA, middle cerebral artery; TIA, transient ischaemic attack; VA, vertebral artery.
- Table 1
Inclusion and exclusion criteria of BASIS trial
Inclusion criteria (1) 35–80 years old. (2) Primary or recurring sICAS patients defined as a recent TIA within the past 90 days or ischaemic stroke between 14 days and 90 days prior to enrolment caused by severe atherosclerotic stenosis (70%–99%) of a major intracranial artery, who underwent at least one antithrombotic drug and/or standard vascular risk factors medical management. (3) Severe atherosclerotic stenosis (70–99% according to WASID method diagnosed by DSA with≤10 mm-lesion length, ≥1.5 mm diameter, and normal distal artery occurs in a major intracranial artery including terminal internal carotid artery (ICA) C4-C7 segments, middle cerebral artery (MCA) M1 segment, basilar artery (BA), and vertebral artery (VA) V4 segment. (Whether the patient is enrolled in BASIS depends on the investigator’s judgement of the patient’s situation with respect to the curvature and angle of the lesion). (4) Patients or their legally authorised representatives signed the informed consent before enrollment in the study. Exclusion criteria (1) The patient who plans to undergo more than three-grade surgery in the next 90 days or underwent surgery in the last 30 days. (2) In the last 24 hours prior to enrolment, the patient received thrombolysis treatment. (3) In the last 24 hours prior to enrolment, the patient suffered neurological deficits worsened. (4) In the last 14 days prior to enrolment, the patient with acute ischaemic stroke onset. (5) In addition to the lesion artery and its supplying artery, other intracranial arteries with 70%–99% stenosis. (6) More than 50% stenosis of the supplying artery of the lesion artery (eg, MCA severe stenosis (lesion artery) with more than 50% stenosis of ipsilateral ICA (supplying artery) should be excluded; BA severe stenosis (lesion artery) with more than 50% stenosis of dominant VA (supplying artery) stenosis should be excluded), non-lesion side extracranial arteries with more than 70% stenosis, and bilateral VA stenosis with more than 70% stenosis in patients with balanced VA should be excluded (cannot identify lesion VA) should be excluded. But we don’t exclude that the dominant VA is the lesion artery with contralateral VA is dysplasia or slender or the contralateral VA terminating at the posteroinferior cerebellar artery. (7) Perforator stroke (except stenotic degree >70% of supplying artery, accompanied by poor collaterals or haemodynamic compromise).21 (8) Pre-enrolment modified Rankin Scale (mRS) 4–6. (9) Non-atherosclerotic diseases (eg, vascular inflammatory lesions due to infection, post-irradiation, postpartum status, sickle cell anaemia, autoimmune diseases, suspected vasospasm, moyamoya disease, fibromuscular dysplasia and arterial dissection). (10) Lesion artery with severe calcification and close neighbour stenosis. (11) Accompanied by intracranial aneurysms or intracranial arteriovenous malformations or intracranial tumours. (12) In the last 90 days, the patient with intracranial haemorrhage such as intraventricular haemorrhage, epidural haemorrhage, subarachnoid haemorrhage, parenchymal haematoma or subdural haemorrhage, etc. (13) The patient undergoing balloon angioplasty, endarterectomy or stenting for original lesion vessel or its primary supplying vessel, or planning to undergo stenting. (14) For other diseases, the patient can not undergo dual antiplatelet therapy. (15) The ischaemic event that is highly suspected to be due to vascular embolism from an extracranial arterial segment such as ipsilateral neck/chest arterial occlusion) or cardio embolism such as left ventricular thrombus, mitral stenosis, atrial fibrillation, myocardial infarction within 6 weeks, patent foramen ovale, etc. (16) Tortuous arterial route unable to acquire stable arterial access. (17) The patient who is allergy response to aspirin, contrast agents, balloon components, clopidogrel, heparin or anaesthetics. (18) Severe liver dysfunction (ALT>3 time normal value upper limit or AST>3 time of normal value upper limit) or severe kidney dysfunction (serum creatinine>2 time normal value upper limit). (19) Women who are pregnant or lactating. (20) Hb<100 g/L, INR>1.5 (irreversible), platelet<100×109/ L, coagulation dysfunction or irreversible bleeding. (21) The patient with radial artery, renal artery or coronary artery disease that need simultaneous interventional therapy. (22) Life expectancy is<1 year. (23) Due to cognitive or emotional disorders or mental illness, the patient who cannot finish the follow-up. (24) The patient who joins other clinical trials (medical device or drug) and has not finished programme need yet. (25) Investigators consider the patient who is not suitable for enrolling in the present trial. BASIS, Balloon Angioplasty for Symptomatic Intracranial Artery Stenosis; Hb, haemoglobin; INR, international normalized ratio; sICAS, symptomatic intracranial artery stenosis.
- Table 2
Assessment schedule
Visit Visit 1 Visit 2 Visit 3 Visit 4 Visit 5 Visit 6
Telephone interviewVisit 7 Follow-up 1 year to 3 years
(Visit 8, 9, 10, 11)Assessment Baseline15 days～0 day Angiogram 0 day Discharge 30 days±7 days 90 days±7 days 6 months±14 days 1 year±30 days 6 months intervals Informed consent √ Inclusion/exclusion criteria check √ History and physical examination √ Vital signs* √ √ √ √ √ √ Blood laboratory test† and urine routine test √ √ √ √ √ Coagulation function‡ √ FBG, HbA1c§ √ √ √ √ Platelet aggregation test and/or CYPC219 genotype test¶ √ ECG √ MRI/CT √ √ CTP** √ √ √ DSA/CTA/MRA √ √ Life-style modification review†† √ √ √ √ √ √ √ mRS √ √ √ √ √ √ NIHSS (neurological examination) examination) √ √ √ √ EQ-5D √ √ √ MoCA¶ √ √ √ HR-VWI,TCD¶ √ √ Medication review and patient compliance survey √ √ √ √ √ AE, SAE and endpoints‡‡ √ √ √ √ √ √ √ √ *Vital signs: body temperature, blood pressure, respiration rate, heart rate.
†Blood laboratory test includes blood routine and biochemistry examinations, hepatic and renal function tests.
‡Coagulation function: PT, APTT, TT, FIB, INR.
§HbA1c is an optional inspection but is recommended for patients with diabetes mellitus.
¶Platelet aggregation test, CYPC219 genotype test, MoCA, HR-VWI and TCD test are optional according to the actual situation of the centre.
**CTP is an optional inspection, but is recommended for patients with haemodynamic compromise, poor collateral or perforator stroke.
††Life-style modification review: including whether to smoke and the number of cigarettes per day; Weight: reflect the patient’s weight control through the patient’s weight and BMI; Exercise: number of exercises per week and duration of each exercise.
‡‡After 1 year of follow-up, follow-up will focus on AE, SAE and endpoint events;
AE, adverse event; CTA, CT angiography; CTP, CT perfusion; DSA, digital subtraction angiography; ECG, electrocardiograph; EQ-5D, quality-of-life EuroQol-5 Dimensions; FBG, fasting blood glucose; HbA1c, glycosylated haemoglobin; HR-VWI, high-resolution vessel wall imaging; INR, international normalized ratio; MoCA, montreal cognitive assessment; MRA, magnetic resonance angiography; mRS, modified Rankin scale; SAE, serious adverse event; TCD, transcranial Doppler.
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