Status:
COMPLETED
Imaging Guided Patient Selection for Interventional Revascularization Therapy
Lead Sponsor:
Penumbra Inc.
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief 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 ...
Detailed Description
Study Title: The START Trial: Clinical Outcome in Acute Stroke Treatment after Imaging Guided Patient Selection for Interventional Revascularization Therapy Study Objective: The objective of this cli...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT00963989
Start Date
September 1 2009
End Date
September 1 2016
Last Update
November 23 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425