Early Endovascular Treatment in Isolated Internal Carotid Artery Occlusion

NCT07016854 | Recruiting

• 1 other identifier: EVT-iICAO
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke, Acute Ischemic

Keywords

endovascular treatment; isolated internal carotid artery occlusion

Outcome Measures

Primary Outcomes (1)

• Good clinical outcome

  Score in modified Rankin Scale (mRS) ≤ 2

  90（±14）days after randomization

Secondary Outcomes (7)

• National Institute of Health Score Scale (NIHSS)

  24（-6/+12）hours after randomization

• Recanalization rate of internal carotid artery

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

• Early neurologic improvement

  24 hours after randomization

• Early neurological deterioration

  24 hours or 5-7 days after randomization

• Mortality

  90 days after randomization

Study Arms (2)

Endovascular treatment plus the best medical treatment

EXPERIMENTAL

Procedure: Endovascular treatment; Drug: The best medical treatment

The best medical treatment

ACTIVE COMPARATOR

Drug: The best medical treatment

Interventions

Endovascular treatment PROCEDURE

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.

Endovascular treatment plus the best medical treatment

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.

Endovascular treatment plus the best medical treatment; The best medical treatment

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sir Run Run Shaw Hospital: lead

Study Sites (1)

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, 310000, China

RECRUITING

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2025
• First Posted: June 12, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 12, 2025

Record last verified: 2025-06

Locations

CN (1)