Endovascular Treatment of Acute Ischemic Stroke With Underlying Intracranial Artery Stenosis

NCT06260969 | Recruiting FDA Device

• 1 other identifier: TJHH-2023-WM13
• Study Type: observational
• Target: 470
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Large Vessel Occlusion; Intracranial Artery Occlusion With Cerebral Infarction; Endovascular Treatments; Acute Ischemic Stroke

Keywords

Endovascular treatments; Acute ischemic stroke; Stroke etiology; Retrieved clots; Intracranial artery stenosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Proportion of patients with a good prognosis early after treatment

  24 hours after thrombectomy

• Change in final cerebral infarct volume relative to baseline at 24 (-2/+12) hours postoperatively on CT/MR

  24 hours after thrombectomy

• Vascular recanalization

  Immediately after thrombectomy

Study Arms (1)

Endovascular therapy

Direct balloon dilation vs stenting vs embolectomy + tirofiban vs embolectomy + balloon dilation vs embolectomy + balloon dilation + intracranial stenting

Device: balloon dilatation

Interventions

balloon dilatation DEVICE

Direct balloon dilation vs stenting vs embolectomy + tirofiban vs embolectomy + balloon dilation vs embolectomy + balloon dilation + intracranial stenting

Also known as: endovascular stenting, aspiration catheter, stent retriever, Tirofiban, intracranial stenting, normal saline

Endovascular therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tianjin Huanhu Hospital: lead

Study Sites (1)

Tianjin Huanhu Hospital

Tianjin, Tianjin Municipality, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Thrombosis specimens；Blood samples

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

• Ming Wei, doctorate

  Tianjin Huanhu Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming Wei, PhD

CONTACT

13502182903; drweiming@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Neurosurgery, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: December 30, 2023
• First Posted: February 15, 2024
• Study Start: September 1, 2022
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: February 15, 2024

Record last verified: 2024-02

Locations

CN (1)