Endovascular Treatment of Acute Ischemic Stroke With Underlying Intracranial Artery Stenosis

Endovascular Treatment of Acute Ischemic Stroke With Underlying Intracranial Artery Stenosis: a Prospective, Multicentre Registry Study

The study is a prospective multicentre registry study. Patients admitted to 10 stroke centres nationwide from September 2022 to September 2025 with acute ischaemic stroke due to large vessel occlusion considering underlying ICAS and treated with emergency endovascular thrombolysis were included for analysis. Patients who met the general inclusion criteria underwent thrombectomy and the necessary remedial treatment.

Study Overview

• Status: Recruiting
• Conditions: Acute Ischemic Stroke; Large Vessel Occlusion; Intracranial Artery Occlusion With Cerebral Infarction; Endovascular Treatments
• Intervention / Treatment: Device: balloon dilatation

Detailed Description

The focus of this trial is to investigate the neuroprotective effects of endovascular hypothermia on the refractory disease of large vessel occlusion with underlying ICAS by performing different modes of endovascular interventions including stenting, balloon dilationand balloon dilation combined with stenting in patients who meet clinical and imaging criteria. The clinical prognosis of patients with different treatment modalities will be followed up to provide high quality clinical evidence to guide the interventional treatment of potential large vessel occlusions in ICAS. The main objectives of the study were to establish a prospective cohort of acute large vessel occlusions with potential ICAS treated with endovascular therapy based on the specific etiology of stroke with a high prevalence of intracranial atherosclerotic stenosis in the Chinese population; to explore the efficacy and safety of endovascular therapy for acute ischaemic stroke with potential ICAS; to investigate the use of different endovascular treatment modalities for acute ischaemic stroke with potential ICAS in the Chinese population; and to explore the neuroprotective effects of selective endovascular hypothermia on large vessel occlusions with potential ICAS. To explore the neuroprotective effect of selective endovascular hypothermia on large vessel occlusion in potential ICAS. To provide objective data and theoretical support for the choice of treatment for large vessel occlusion in underlying ICAS

• Study Type: Observational
• Enrollment (Estimated): 470

Contacts and Locations

• Study Contact: Name: Ming Wei, PhD; Phone Number: 13502182903; Email: drweiming@163.com

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China
      • Recruiting
      • Tianjin Huanhu Hospital
      • Contact: Ming Wei; Phone Number: 13502182903; Email: drweiming@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with acute cerebral infarction with underlying intracranial artery stenosis receiving endovascular treatment

Description

Inclusion Criteria:

• CT scan to exclude intracranial haemorrhage；CT angiography (CTA), magnetic resonance angiography (MRA) or digital subtraction angiography showing occlusion of the distal intracranial carotid artery or the first segment of the middle cerebral artery；ELVO with a base ICAS of > 70%；Mechanical thrombectomy within 6h after symptom onset in ischemic stroke；NIHSS≥6；receiving endovascular treatments；informed consent form signed by the patient or their legal representatives.

Exclusion Criteria:

• Hemorrhagic body, coagulation factor deficiency or oral anticoagulant therapy(INR > 3.0)；Baseline platelet count <50,000/µL；Baseline blood glucose <50mg/dL or >400mg/dL；Intractable hypertension(systolic blood pressure >220 mmHg or diastolic blood pressure >110 mmHg) that cannot be controlled by medication；Patients intubated without a NIHSS score assessed by a neurologist or emergency physician prior to intubation；Stroke attack with epilepsy affecting baseline NIHSS score；End-stage diseases leading to less than one year of expected survival for patients；Severe allergy to contrast media；Patients with renal insufficiency (blood creatinine ≥ 3 mg/dL)；Female patients who are pregnant or breastfeeding；The patient is participating in other drugs or device studies that may affect this study；Patient with cerebral vasculitis

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Endovascular therapy; Direct balloon dilation vs stenting vs embolectomy + tirofiban vs embolectomy + balloon dilation vs embolectomy + balloon dilation + intracranial stenting	Device: balloon dilatation; Direct balloon dilation vs stenting vs embolectomy + tirofiban vs embolectomy + balloon dilation vs embolectomy + balloon dilation + intracranial stenting; Other Names: normal saline; Tirofiban; endovascular stenting; aspiration catheter; stent retriever; intracranial stenting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients achieving a clinical prognosis of mRS 0-2 at 90 days	Proportion of patients achieving a clinical prognosis of mRS 0-2 at 90 days	patients achieve a clinical prognosis of mRS 0-2 at 90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with a good prognosis early after treatment	Decrease in NIHSS score ≥ 8 or NIHSS score of 0-2 in 24 (-2/+12) hours	24 hours after thrombectomy
Change in final cerebral infarct volume relative to baseline at 24 (-2/+12) hours postoperatively on CT/MR	Change in final cerebral infarct volume relative to baseline at 24 (-2/+12) hours postoperatively on CT/MR	24 hours after thrombectomy
Vascular recanalization	Revascularisation assessed by DSA immediately after thrombectomy；Postoperative revascularisation assessed by CTA/MRA/DSA using Arterial Occlusive Lesion (AOL) grading at 24 (-2/+12) hours postoperatively；Application of bedside TCD for assessment of revascularisation	Immediately after thrombectomy

Collaborators and Investigators

• Sponsor: Tianjin Huanhu Hospital
• Investigators: Principal Investigator: Ming Wei, doctorate, Tianjin Huanhu Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: December 30, 2023
• First Submitted That Met QC Criteria: February 14, 2024
• First Posted (Actual): February 15, 2024

Study Record Updates

• Last Update Posted (Actual): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Acute ischemic stroke; Stroke etiology; Intracranial artery stenosis; Endovascular treatments; Retrieved clots
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pathological Conditions, Anatomical; Brain Ischemia; Brain Infarction; Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction; Constriction, Pathologic; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Tirofiban
• Other Study ID Numbers: TJHH-2023-WM13

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes