REal-World Analyses of Stroke - Thrombus Occlusion REtrieval

Completed

Conditions studied: Acute Ischemic Stroke, Vessel Occlusion, Stroke, Ischemic

In brief

To collect real-world evidence allowing assessment of functional, imaging, and safety outcomes of MicroVention market-released acute ischemic stroke devices when used at the direction of the treating physician.

Key facts

Study ID

NCT04451525

Run by

Microvention-Terumo, Inc.

People needed

710

Starts

2020-07-15

Expected to finish

2025-06-09

Last updated by the study team

2025-06-18

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient is ≥ 21 and ≤ 85 years of age.
• Patient has a pre-morbid mRS ≤ 1.
• Neuroimaging (CT/CTA and/or MR/MRA collected at no more than 90 minutes prior to groin puncture) demonstrates large vessel proximal occlusion (distal ICA through MCA bifurcation).
• Patient has an NIHSS score ≥ 5 at time of intervention.
• Symptom onset is within 8 hours of when groin puncture can be achieved.
• Patient will undergo treatment via femoral access and the decision to use femoral access has been made by the treating physician outside the context of the RESTORE study and prior to study enrollment.
• Patient will be treated using the direct aspiration as first line treatment technique and the decision to use this technique and the study device has been made by the treating physician outside the context of the RESTORE study and prior to study enrollment.
• Patient or patient's legally authorized representative (LAR) has provided written informed consent.
• Patient is considered by the treating physician to be available for and able to complete all follow-up visits with a trained site investigator.

You may not qualify if…

• Inability to obtain written informed consent.
• Patient is < 21 or > 85 years of age.
• Patient has a pre-morbid mRS ≥ 2.
• More than 8 hours have passed since symptom onset.
• Severe unilateral or bilateral carotid artery stenosis or dissection requiring stent treatment.
• Presence of a pre-existing large territory infarction.
• Absent femoral pulses or other condition preventing femoral access.
• Patient has vascular anatomy/tortuosity or other vascular disease preventing access to the target occlusion or that will likely result in unstable access.
• Patient is pregnant.
• Known or suspected pre-existing/chronic large vessel occlusion in the symptomatic territory.
• Patient has known, untreatable hypersensitivity to contrast dye, iodine or any component of the treatment device that cannot be medically controlled.
• The intracranial occlusion is suspected to be chronic based on past imaging, clinical history, or clinical judgment.
• Patient has a severe or life-threatening comorbidity that could confound study results, or that will render the procedure unlikely to benefit the patient.
• Patient is unable to complete scheduled follow-up assessments due to comorbidities, geographical limitations, or a life expectancy of less than 3 months.
• Patient is enrolled in another device or drug study in which participation could confound study results.
• Imaging (CT or MR) exclusion criteria:
• Presence of intracerebral hemorrhage as evidenced on initial imaging
• Ischemic changes in the posterior circulation territories (including the vertebra-basilar and posterior cerebral arteries)
• Significant mass effect with midline shift
• Evidence of intracranial tumor
• Baseline ischemic core lesion >50 cc
• Involvement of > 1/3 of the middle cerebral artery territory
• ASPECTS <6 (hemispheric sulcal effacement and/or loss of grey-white differentiation alone are not contraindications for treatment)
• Cohort II:
• Inclusion Criteria:

Where it is running

• Pacific Neuroscience Institute (Providence) — Burbank, California, United States
• Mercy San Juan - Dignity Health Research Institute — Carmichael, California, United States
• Kaiser Permanente, Northern California — Redwood City, California, United States
• UCHealth Memorial — Colorado Springs, Colorado, United States
• Memorial Healthcare System — Hollywood, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• Augusta University — Augusta, Georgia, United States
• The Queen's Medical Center — Honolulu, Hawaii, United States
• Javon Bea Hospital — Rockford, Illinois, United States
• Goodman Campbell Brain and Spine — Carmel, Indiana, United States
• University of Maryland — Baltimore, Maryland, United States
• Brigham and Women's hospital — Boston, Massachusetts, United States
• Baystate Medical Center — Springfield, Massachusetts, United States
• Ascension Borgess — Kalamazoo, Michigan, United States
• Munson Medical Center — Traverse City, Michigan, United States
• University of Michigan Health West — Wyoming, Michigan, United States
• Allina Health (Abbott Northwestern Hospital) — Minneapolis, Minnesota, United States
• SSM Health — Bridgeton, Missouri, United States
• University of Missouri — Columbia, Missouri, United States
• Washington University — St Louis, Missouri, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• HMH Jersey Shore University Medical Center — Neptune City, New Jersey, United States
• Northshore University Hospital - Northwell — Manhasset, New York, United States
• Mt. Sinai Health System — New York, New York, United States
• Stony Brook Medicine — Stony Brook, New York, United States

Full record on ClinicalTrials.gov

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