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Early Endovascular Treatment in Isolated Internal Carotid Artery Occlusion

ConditionStroke, Acute Ischemic
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSir Run Run Shaw Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Endovascular treatment

    Procedure/Surgery

    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.

  • The best medical treatment

    Drug

    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.

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Endovascular treatment plus the best medical treatmentExperimental treatment 2 interventions
Group B: The best medical treatmentActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Good clinical outcome

Score in modified Rankin Scale (mRS) ≤ 2

Time frame
90（±14）days after randomization

Secondary outcomes

1

National Institute of Health Score Scale (NIHSS)

Time frame
24（-6/+12）hours after randomization
2

Recanalization rate of internal carotid artery

Time frame
24（-6/+12）hours and 90（±14）days after randomization
3

Early neurologic improvement

The NIHSS score of 0-2 at 24 hours or a decrease of ≥8 points from baseline

Time frame
24 hours after randomization
4

Early neurological deterioration

The NIHSS score at 24 hours or on 5-7 days increased by ≥4 points from baseline

Time frame
24 hours or 5-7 days after randomization

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sir Run Run Shaw Hospital

Lead sponsor

Source ClinicalTrials.gov
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