Thrombectomy in Patients Ineligible for iv tPA (THRILL)

This is an interventional treatment trial for Ischemic Stroke focused on measuring Cerebral Stroke, Stroke, Acute, Brain Infarction Read More

Inclusion Criteria:

• Patient is ineligible for treatment with IV tPA according to licensing criteria (e.g.

anticoagulation, previous surgery, or beyond 4.5 hours after symptom onset).

• Randomization within 7 hours after stroke onset.
• Endovascular treatment is expected to be finished within 8 hours after symptom onset by judgment of the interventional Neuroradiologist in charge.
• Patient must demonstrate clinical signs and symptoms attributable to target area of occlusion consistent with the diagnosis of ischemic stroke, including impairment of the following: language, motor function, sensation, cognition, gaze, and/or vision for at least 30 minutes without relevant improvement.
• Female and male patient between 18-80 years of age
• NIHSS Score of >7 and <25
• Patient signed informed consent (IC) form by patient, legal representative, or by an independent physician who is familiar with this types of illness if the other options are not possible.
• A new focal occlusion confirmed by imaging (MRA/CTA) to be accessible to the thrombectomy device, and located in the M1 of the middle cerebral artery (MCA) and/or the intracranial segment of the distal internal carotid artery (ICA).
• Prior to new focal neurological deficit, mRS score was ≤1.

Exclusion Criteria:

• Patient is eligible for and receives IV tPA according to licensing criteria
• Patient with an international normalized ratio (INR) of >3
• Patient is an active participant in another drug or device treatment trial for any disease state, or patient is expected to start participation in another drug or device treatment trial while enrolled in this protocol, unless approved by Sponsor.
• Patient has pre-existing neurological or psychiatric disease that could impede the study results or would confound the neurological or functional evaluations.
• Patient has carotid dissection, high grade stenosis ≥ 70% proximal to occlusion that requires stenting, or excessive tortuosity to gain access to occlusion, as determined by MRA/ CTA of neck and head.
• Patient has vascular disease preventing endovascular treatment (e.g. aortic dissection or aneurysm, no arterial transfemoral access)
• Patient has history of contraindication for contrast medium.
• Patient is known to have infective endocarditis
• CT scan or MRI with evidence of: Mass effect or intracranial tumor, or hypodensity on unenhanced CT and cerebral blood volume (CBV) drop on CBV maps on Computed Tomography Perfusion (CTP), or, alternatively as per institutional standard, restricted diffusion on Diffusion weighted imaging (DWI) with an Alberta Stroke Program Early CT score (ASPECTs) of 6 or less
• Female of childbearing potential who is known to be pregnant and/or lactating or who has a positive pregnancy test on admission.
• Patient"s anticipated life expectancy is less than 6 Months.