An interventional study of Intra-arterial Therapy in Ischemic Stroke, sponsored by Mercy Health Ohio. Completed at 43 sites in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-04-23.
Sponsored by Mercy Health Ohio · Not applicable, Interventional, and Treatment
The primary objective of the trial is to establish the effectiveness of IAT (versus medical management) in patients with moderate-large infarcts (NCCT ASPECTS 2-5) at baseline, with adaptive enrichment to better define the upper limit of infarct volume for treatment eligibility. Furthermore, the investigators aim to determine whether certain subgroups of patients with large baseline infarcts will have a greater treatment benefit. Finally, the investigators will assess the agreement of ASPECTS scores between site investigators, the core imaging lab, and automated software.
Prospective, randomized, open-label, blinded endpoint study. Patients presenting with symptoms of AIS who have evidence of a moderate-large infarct volume (Non-contrast CT Alberta Stroke Program Early CT score [NCCT ASPECTS] 2-5 in the anterior circulation will be assigned to either best medical management alone (including IV rtPA) or intra-arterial treatment (IAT) with mechanical thrombectomy added to best medical management. Each treated patient will be followed and assessed for 3 months after randomization.
Imaging evidence of moderate-large infarct defined as:
Exclusion Criteria:
CT evidence of the following conditions:
Patients randomized to the medical therapy arm will receive standard medical therapy based on current AHA guidelines.
For patients randomized to the intra-arterial therapy arm, sites will use local protocols for femoral access, sedation, heparin infusion, monitoring, etc. Mechanical thrombectomy will be performed with FDA-approved thrombectomy devices in accordance with the IFU.
Procedure: Intra-arterial Therapy
Mechanical Thrombectomy is a treatment for stroke that removes clots that block large blood vessels.
Also known as: Thrombectomy
Utility-weighted 90-day Modified Rankin Score
Scale used for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Scale ranges from 0-6 where 0 represents no symptoms and 6 represents death. 0 = No symptoms at all. 1. = No significant disability despite symptoms; able to carry out all usual duties and activities. 2. = Slight disability; unable to carry out all previous activities but able to look after own affairs without assistance. 3. = Moderate disability requiring some help, but able to walk without assistance. 4. = Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance. 5. = Severe disability; bedridden, incontinent, and requiring constant nursing care and attention. 6. = Death
Time frame: 90 days post randomization
Plan to share: No — All shared data will be aggregate.
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Mercy Health Ohio