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New treatment option for Stroke, Acute Ischemic
Official title Early Endovascular Treatment in Isolated Internal Carotid Artery Occlusion
ClinicalTrials.gov ID: NCT07016854
What this study is testing
What is The best medical treatment?
The best medical treatment is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for stroke, acute ischemic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Neurological deficit with a NIHSS of \>5, or ≤5 points with disabling symptoms (complete hemianopsia, severe aphasia, neglect, any limb weakness that...
- 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)...
You likely can't join 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...
- 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...
- 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...
See the full eligibility 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)...
- 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...
- 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...
- mRS Score before stroke ≤2.
- Patient/Legally Authorized Representative has signed the Informed Consent form.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.