Thrombectomy vs. Medical Management Beyond 24 Hours

Clinical Trial Title Medical Management with Endovascular Thrombectomy versus Medical Management Alone in Patients Presenting Beyond 24 Hours of Last Known Well

National Clinical Trial Number: NCT07115940

Clinical Trial Protocol Description:

This study is accepting patients at both Rush University Medical Center and Rush Copley Medical Center. Please see contact information below to join the study at one location.

To evaluate if addition of endovascular thrombectomy to medical management in patients presenting with acute ischemic stroke and a proximal large vessel occlusion in anterior circulation between 24 and 72 hours of stroke onset results in achieving better functional outcomes (measured using modified Rankin Scale Scores) at 90-day (+/- 15-day interval).

Clinical Trial Eligibility Criteria:

In order to participate you must meet the following general inclusion criteria:

Are an adult, 18-85* years of age (inclusive of both 18 and 85 years of age), with the final diagnosis of an acute ischemic stroke.
Have a NIHSS ≥ 6.
have a time from last-known-well to randomization >24 - 72 hours
Have pre-stroke modified Rankin Scale score of 0-1.
Are eligible for thrombectomy and medical management.
Have signed Informed Consent obtained.
Are willing to comply with the protocol follow-up requirements.
Have an anticipated life expectancy of at least 3 months.

You must also meet the following imaging inclusion criteria:

Have proven large vessel occlusion in ICA or MCA-M1 occlusion (carotid occlusions can be cervical or intracranial, with or without tandem MCA lesions), as determined by MR Angiography (MRA) or CT Angiography (CTA).
Have CT ASPECTS 3-10.
Have CT Perfusion ischemic core (rCBF <30%) volume ≤150 ml OR MR Diffusion ischemic core (ADC <620x10-6 mm2/s) volume ≤150ml.

You will be excluded from the study if any of the following general exclusion criteria apply to you:

Are currently participating in another investigational interventional drug or device study.
Have a baseline platelet count <100,000/μl

You will also be excluded from the study if any of the following imaging exclusion criteria apply to you:

Have evidence of intracranial tumor (except small meningioma <3cm without signs of edema or inflammation), acute intracranial hemorrhage, or arteriovenous malformation.
Have significant mass effect, defined as midline shift (>3mm) using foramen of monroe (anterior margin of third ventricle) as the marker for midline instead of septum pellucidum AND/OR Effacement of sulci in contralateral hemisphere.
Have evidence of internal carotid artery dissection that is flow limiting or aortic dissection.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.