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
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
Treatments tested in this trial
- Endovascular treatment
- The best medical treatment
Treatment groups
140 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov