Patient Selection Using MR With Non-Perfusion Imaging for Endovascular Treatment Within 6 to 24 Hours
Patient Selection Based on Penumbra-core Mismatch Using MR With Non-Perfusion Imaging for Endovascular Treatment Within 6 to 24 Hours: Rationale and Trial Design
Tianjin Huanhu Hospital
352 participants
Jan 1, 2019
INTERVENTIONAL
Conditions
Summary
We will conduct a multicenter, prospective, randomized, open-label, blinded endpoint trial with a non-inferiority design in patients who present 6 to 24 hours after symptom onset with LVO. Patients who meet eligibility criteria will be randomly assigned to the Non-perfusion or Perfusion group with a 1:1 ratio. In the Non-perfusion group, patients with penumbra-core mismatch (defined as the FLAIR Vascular Hyperintensity (FVH) extending beyond the boundary of the DWI cortical lesions) will receive EVT. In the Perfusion group, patients with perfusion mismatch (defined as regional cerebral blood flow (\<30%) \< 70 ml with mismatch ratio ≥ 1.8 and mismatch volume ≥ 15 ml) will receive EVT. Patients in both groups will receive guideline-based medical treatment. If patients in both groups do not meet the criteria for EVT, only guideline-based medical treatment will be administered.
Eligibility
Inclusion Criteria8
- Age of 18 years or older；
- Anterior circulation LVO (internal carotid artery, or middle cerebral arteries (MCA)M1, M2 proximal segment) confirmed by computed tomographic angiography (CTA)/magnetic resonance angiography (MRA)；
- NIHSS score ≥6 at the time of randomization；
- ASPECTS score ≥ 6 on NCCT；
- Time from stroke onset to randomization within 6-24 hours；
- Pre-stroke mRS score 0-2；
- Completed MRI and perfusion imaging or enable to complete MRI and/or perfusion imaging；
- Signed informed consent
Exclusion Criteria12
- Pregnancy, or those potential with positive urine or serum beta Human Chorionic Gonadotrop in test；
- A history of severe allergy to contrast media；
- Uncontrolled hypertension (SBP \>185mmHg; DBP\>110mmHg)；
- Hereditary or acquired bleeding tendency, coagulation factor deficiency, recent anticoagulant medication (A platelet count of less than 100 x 109 /L；INR\>3 or PPT more than 3 times normal)；
- Active hemorrhage or preexisting tendency to hemorrhage；
- Presence of signs of cardiac, hepatic or renal failure；
- Baseline blood glucose\<50mg/dL (2.78mmol) or \>400mg/dL (22.20mmol)；
- Participation in other interventional randomized clinical trials that may confound the outcome assessment of the trial；
- Life expectancy \< 1 year；
- Patients who are unable to complete the 90-day follow-up；
- A stroke attack with epilepsy that prevents an accurate NIHSS score from being obtained；
- Other circumstances that the investigator considers inappropriate for participation in the trial(such as violation of guidelines or institutional processing principles during the screening process).
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Endovascular therapy, as an adjunct to standard stroke therapy, may be beneficial for a very select population of patients who present with an acute ischemic stroke and have a proven large, proximal occlusion on imaging. Endovascular therapy includes any one or more of the following: Intra-arterial thrombolytic therapy, aspiration, stent retrieval, or a combination of multiple mechanical devices.Remedial measures after failed thrombectomy are permitted by pharmacologic arterial thrombolysis or intravenous infusion of antiplatelet drugs, such as tirofiban or rt-PA
best drug conservative therapy could be uesd in patients who with no indication of surgery
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05735301