N/A N=146 Treatment

Imaging Guided Patient Selection for Interventional Revascularization Therapy

Acute Ischemic Stroke

Bottom Line

View on ClinicalTrials.gov: NCT00963989 ↗

Enrolled (actual)

146

Serious AEs

5.5%

Results posted

Nov 2021

Primary outcome: Primary: Functional Outcome as Defined by a mRS of 0-2 at 90 Days Post-procedure — 57 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Penumbra System (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Penumbra Inc.
Primary completion: Sep 2016

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	—

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.

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.

View full record on ClinicalTrials.gov →

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.