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New treatment option for Stroke, Acute Cerebral Infarction
Official title Perfusion Imaging Evaluation for Ischemic Stroke on 6-24 Hours Undergoing Endovascular Thrombectomy
ClinicalTrials.gov ID: NCT03502408
What this study is testing
- What it's testing
- This study aims to evaluate the hypothesis that thrombectomy devices plus medical management leads to superior clinical outcomes in acute ischemic stroke patients at 90 days as compared to medical management alone in appropriately selected subjects with the Target Mismatch Profile and an MCA (M1 and M2 segment) or ICA occlusion or BA who have endovascular thrombectomy initiated between 6-24 hours after last seen well.
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
- Clinical
- Clinical signs and symptoms consistent with the diagnosis of an acute ischemic stroke
- Age ≥18 years
- NIHSS ≥ 6
- Endovascular thrombectomy can be initiated (femoral puncture) between 6 and 24 hours after time last know well
You likely can't join if
- Clinical Exclusion Criteria:
- Other serious, advanced, or terminal illness (investigator judgment) or life expectancy is less than 90 days
- Subject with a co-morbid disease or condition that would confound the neurological and functional evaluations or compromise survival or ability to...
- Unable to undergo a contrast brain perfusion scan with either MRI or CT
- Pregnant
- Known serious sensitivity to radiographic contrast agents
See the full eligibility criteria
- Clinical
- Clinical signs and symptoms consistent with the diagnosis of an acute ischemic stroke
- Age ≥18 years
- NIHSS ≥ 6
- Endovascular thrombectomy can be initiated (femoral puncture) between 6 and 24 hours after time last know well
- No significant pre-stroke disability (pre-stroke mRS must be ≤ 3 )
- Patient/Legally Authorized Representative has signed the Informed Consent form Imaging
- ICA or MCA-M1 or MCA-M2 or BA occlusion (carotid occlusions can be cervical or intracranial with or without tandem MCA lesions) as evidenced by MRA or 4D-CTA
- Target Mismatch Profile on CT perfusion or MR perfusion: ischemic core volume is ≤ 70 ml, mismatch ratio is \>/= 1.2 )
- Clinical Exclusion Criteria:
- Other serious, advanced, or terminal illness (investigator judgment) or life expectancy is less than 90 days
- Subject with a co-morbid disease or condition that would confound the neurological and functional evaluations or compromise survival or ability to complete follow-up assessments
- Unable to undergo a contrast brain perfusion scan with either MRI or CT
- Pregnant
- Known serious sensitivity to radiographic contrast agents
- Treated with rtPA \>6 hours after time last known well
- Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency; recent oral anticoagulant therapy with INR \> 3 (recent use of one of the new oral anticoagulants is not an exclusion if estimated GFR...
- Seizures at stroke onset if it precludes obtaining an accurate baseline NIHSS
- Current participation in another investigational drug or device treatment study
- Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency
- Any other condition that, in the opinion of the investigator, precludes an endovascular procedure or poses a significant hazard to the subject if an endovascular procedure was performed. Neuroimaging Exclusion Criteria:
- ASPECTS score \<6 on non-contrast CT (if patient is enrolled based on CT perfusion criteria)
- Evidence of intracranial tumor (except small meningioma), acute intracranial hemorrhage, neoplasm, subarachnoid hemorrhage, or arteriovenous malformation
- Significant mass effect with midline shift
- Evidence of internal carotid artery dissection
- Intracranial stent implanted in the same vascular territory, known history of arterial tortuosity, and/or other arterial disease that precludes the safe deployment/removal of the thrombectomy device
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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.