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RecruitingNCT06260969Updated Feb 15, 2024

Endovascular Treatment of Acute Ischemic Stroke With Underlying Intracranial Artery Stenosis

An observational study in Large Vessel Occlusion, Intracranial Artery Occlusion With Cerebral Infarction and Endovascular Treatments, sponsored by Tianjin Huanhu Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-15.

Sponsored by Tianjin Huanhu Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year ago, but the record still lists the study as recruiting.
  • Started Sep 2022; still recruiting 4 years 1 month later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
470
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • 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
03

In context

Stroke

7,283 studies on the registry are indexed under Stroke; 2,013 are open to participants now.

This study's planned enrollment of 470 is above the median of 160 across 1,692 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Tianjin Huanhu Hospital is the lead sponsor of 25 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
470 participants (estimated)
Target follow-up
90 Days
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • Endovascular therapy

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

    Device: balloon dilatation

Interventions

  • Deviceballoon dilatation

    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

06

What researchers measure

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

    Time frame: patients achieve a clinical prognosis of mRS 0-2 at 90 days

Secondary outcomes

  1. 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

    Time frame: 24 hours after thrombectomy

  2. 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

    Time frame: 24 hours after thrombectomy

  3. 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

    Time frame: Immediately after thrombectomy

07

Study locations

1 of 1 sites recruiting
  • Tianjin Huanhu Hospital
    Tianjin, Tianjin, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06260969
Lead sponsor
Tianjin Huanhu Hospital
Responsible party
Ming Wei (Director, Head of Neurosurgery, Principal Investigator, Clinical Professor, Tianjin Huanhu Hospital) — Principal investigator
First posted
Feb 15, 2024
Start date
Sep 1, 2022
Primary completion
Sep 30, 2025 (estimated)
Completion
Sep 30, 2025 (estimated)
Last update
Feb 15, 2024

Study contacts

Ming Wei, PhD
Contact
drweiming@163.com
13502182903
Ming Wei, doctorate
principal investigator · Tianjin Huanhu Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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