N/A
Completed N=146
Imaging Guided Patient Selection for Interventional Revascularization Therapy
Source: ClinicalTrials.gov NCT00963989 ↗Enrolled (actual)
146
Serious AEs
5.5%
Results posted
Nov 2021
Primary outcomePrimary: Functional Outcome as Defined by a mRS of 0-2 at 90 Days Post-procedure — 57 Participants
Summary
The primary objective of this clinical evaluation is 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. The secondary objective is to determine if there is a correlation between infarct volume and functional outcome in treated patients at 90 days post-procedure.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Functional Outcome as Defined by a mRS of 0-2 at 90 Days Post-procedure |
57 | — |
| PRIMARY Angiographic Assessment of Vessel Patency as Measured by TIMI Score |
122 | — |
| PRIMARY Angiographic Assessment of Vessel Patency as Measured by Modified TICI Score |
122 | — |
| PRIMARY Procedural Serious Adverse Events During the Procedure |
40 | — |
| SECONDARY Good Neurological Recovery Post-procedure as Defined by a 10 Points or More Improvement on the NIHSS at Discharge |
47 | — |
| SECONDARY Incidence of Symptomatic and Asymptomatic Hemorrhage Based on the ECASS Criteria and Patient Neurological Status Within 24 Hours of the Procedure |
18 | — |
| SECONDARY All Cause Mortality at 90 Days Post-procedure |
37 | — |
Eligibility Criteria
Inclusion Criteria
- From 18 to 85 years of age.
- 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 of 10 or greater.
- Core infarct volume assessed by CTP, CTA or DWI scans within 60 minutes to arterial puncture.
- Signed informed consent.
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 of 1 or greater.
- 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;
- 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.
Data sourced from ClinicalTrials.gov (NCT00963989). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.