Early Endovascular Treatment in Isolated Internal Carotid Artery Occlusion

Official title

Evaluation of Early Endovascular Treatment in Acute Ischemic Stroke With Isolated Internal Carotid Artery Occlusion (EVT-iICAO)

Overview

The primary hypothesis being tested in this trial is that acute ischemic stroke with isolated internal carotid artery occlusion will have improved clinical outcomes when given early endovascular treatment compared with that of given best medical treatment.

Detailed description

Stroke is the leading cause of death and disability among Chinese residents, and ischemic stroke accounts for 70-80% of all strokes. Isolated internal carotid artery occlusion (iICAO) refers to occlusion of the internal carotid artery, which is not involve the circle of Willis, the M1 and the proximal M2 segment of the middle cerebral artery. IICAO accounts for about 20-25% of symptomatic acute internal carotid artery occlusion. Previous studies have shown that despite the best medical treatment, including intravenous thrombolysis, the early recanalization rate of patients with acute iICAO is only 4.4%-23%, and less than half of the patients eventually achieve self-care. Endovascular Treatment (EVT) is the most effective reperfusion therapy for large vessel occlusive stroke. Since only a few retrospective studies have reported the efficacy and safety of early EVT in patients with acute iICAO stroke, there is a lack of high-level prospective evidence so far. Therefore, the aim of this study is to conduct a prospective, multicenter, open-label, randomized controlled clinical trial to evaluate the efficacy and safety of early EVT in patients with acute iICAO stroke.

Interventions

• Procedure Endovascular treatment
  Endovascular treatment could be performed with any recanalization strategy, such as thrombectomy with aspiration or stent and angioplasty with balloon dilation or stent implantation, depending on the operator's choice and anatomical and radiological circumstances. In the setting of emergency stenting, the use of antiplatelet agents will depend on operator preference, anatomy, and bleeding risk.
• Drug The best medical treatment
  Medical treatment includes intravenous thrombolysis, anticoagulant or antiplatelet drugs, etc. which is determined by the attending physician according to the Chinese guidelines or expert consensus.

Primary outcome measures

• Good clinical outcome [Time frame: 90（±14）days after randomization]

Secondary outcome measures (7)

• National Institute of Health Score Scale (NIHSS) [Time frame: 24（-6/+12）hours after randomization]
• Recanalization rate of internal carotid artery [Time frame: 24（-6/+12）hours and 90（±14）days after randomization]
• Early neurologic improvement [Time frame: 24 hours after randomization]
• Early neurological deterioration [Time frame: 24 hours or 5-7 days after randomization]
• Mortality [Time frame: 90 days after randomization]
• Symptomatic intracranial hemorrhage [Time frame: 24（-6/+12）hours after randomization]
• Procedural/device-related adverse events [Time frame: 30（±5）days after randomization]

Eligibility criteria

Inclusion criteria

• Age ≥18.
• Clinical signs consistent with an acute ischemic stroke and randomization no later than 23 hours after the time last known to be well.
• CTP, CTA or enhanced MRA within 1 hour before randomization showed that the offending vessel was isolated internal carotid artery occlusion, namely occlusion of C1-C6 segments (according to Bouthillier's segmentation) at any location. There was no ipsilateral intracranial branch occlusion (T or L shape of internal carotid artery, M1 or M2 segment of middle cerebral artery, A1 or A2 segment of anterior cerebral artery, P1 or P2 segment of posterior cerebral artery).
• Neurological deficit with a NIHSS of >5, or ≤5 points with disabling symptoms (complete hemianopsia, severe aphasia, neglect, any limb weakness that cannot sustain resistance to gravity, and functional loss that is considered by doctors and patients to be potentially disabling by clinical evaluation).
• Mismatch: target Mismatch Profile on CT perfusion or MRI (ischemic core volume is < 70 ml, mismatch ratio is ≥1.8 and mismatch volume is ≥15 ml); clinical-imaging mismatch defined as an ASPECTS score of more than 5, was present if perfusion data were not available or imaging quality was poor enough to be interpreted.
• mRS Score before stroke ≤2.
• Patient/Legally Authorized Representative has signed the Informed Consent form.

Exclusion criteria

• The patient underwent carotid endarterectomy within 1 month.
• Severe comorbid condition with life expectancy less than 6 months at baseline.
• Other suspected cerebrovascular diseases (vasculitis, untreated cerebrovascular malformation, intracranial aneurysm, etc.) based on history and CTA/MRA.
• Women who are pregnant or planning to become pregnant at the time of the study and who are known to be pregnant or breastfeeding at the time of admission.
• Known life-threatening allergic reactions to contrast media or intravascular products.
• Chronic internal carotid artery occlusion, defined as known carotid artery occlusion (imaging examination) ≥30 days before randomization or highly suspected chronic internal carotid artery occlusion based on medical history and CT/MRI.
• Tandem occlusion, which was defined as internal carotid artery occlusion combined with large intracranial vessel occlusion (T or L shape of internal carotid artery, M1 or M2 segment of middle cerebral artery, A1 or A2 segment of anterior cerebral artery, P1 or P2 segment of posterior cerebral artery).
• No known vascular access.
• Suspected aortic dissection based on medical history, clinical evaluation or/and imaging.
• Evidence of intracranial hemorrhage on CT/MRI.
• Patient unable to come or unavailable for follow-up.
• Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations.
• Seizures at stroke onset if they make the diagnosis of stroke doubtful and preclude obtaining an accurate baseline NIHSS assessment.
• Patients have contraindications to the use of heparin and antiplatelet drugs.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Sir Run Run Shaw Hospital — Hangzhou

Identifiers

NCT: NCT07016854 · EVT-iICAO

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗