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Imaging Guided Patient Selection for Interventional Revascularization Therapy
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Status:
This study is currently recruiting participants. 25 sites have committed to this trial of which 4 have received IRB approval, and 1 patient has been enrolled.
Purpose:
To determine the safety and effectiveness of the Penumbra System in a stroke cohort who presents within 8 hours from symptom and with a known core infarct volume at admission. and to determine if there is a correlation between infarct volume and functional outcome in treated patients at 90 days post-procedure.
Location(s):
South Carolina
Year Started:
2009
Year Presented:
2010
Design:
Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study.
Inclusion Criteria
Evidence of proximal anterior circulation large vessel occlusion (TIMI /TICI 0-1) (Tables 2A & B). Target vessel occlusion may include the supra-clinoid segment of the ICA through the M1 segment of the MCA; presented with symptoms consistent with acute ischemic stroke within 8 hours of symptom onset. Patients who presented within 3 hours must be ineligible or refractory to IV rtPA therapy; at time of enrollment, neurological deficit resulting in an NIH Stroke Scale (NIHSS) score > 10; core infarct volume assessed by CTP, CTA or DWI scans within 60 minutes to arterial puncture.
Exclusion Criteria
History of stroke in the past 3 months; vessel tortuosity too difficult to allow endovascular access; pre-existing neurological or psychiatric disease that could confound the study results such as a pre-stroke mRS score > 1; known severe allergy to contrast media; uncontrolled hypertension (defined as systolic blood pressure > 185 mmHg or diastolic blood pressure > 110 mmHg); noncontrast CT evidence of the following conditions before enrollment: significant mass effect with midline shift or evidence of intracranial hemorrhage; angiographic evidence of an arterial stenosis proximal to the occlusion that could prevent thrombus removal; angiographic evidence of preexisting arterial injury; life expectancy less than 90 days; participation in another clinical investigation that could confound the evaluation of the study.
Patient Involvement:
Patients presenting with symptoms of acute ischemic stroke within 8 hours from symptom onset and with a known imaging-defined infarct volume will be enrolled for interventional treatment by the Penumbra System to achieve revascularization of the target vessel territory. Patients will have a baseline NIHSS and mRS. In 90 days wil have follow-up mRS.
Primary Outcome:
Functional outcome as defined by a mRS of 0-2 at 90 days post-procedure; angiographic assessment of vessel patency as measured by TIMI and modified TICI scores at immediate post-procedure; procedural serious adverse events during the procedure.
Secondary Outcome:
Good neurological recovery post-procedure as defined by a 10 points or more improvement on the NIHSS at Discharge; incidence of symptomatic and asymptomatic hemorrhage based on the ECASS criteria and patient neurological status within 24 hours of the procedure; all cause mortality at 90 days post-procedure.
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Source of Information:
ClinicalTrials.gov
Presented at the 2010 International Stroke Conference (February 2010).
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Web Links and Publications:
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This information last updated on: 3/9/2010
Reviewed on: 12/22/2009.
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