Imaging Guided Patient Selection for Interventional Revascularization Therapy

NCT00963989 | Completed Results

• 1 other identifier: CLP 2480.A
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Acute Ischemic Stroke

Keywords

Acute stroke; Large cerebral vessel occlusion; Core infarct volume; Penumbra System; Revascularization; Intracerebral hemorrhage; mRS; NIHSS; Procedural serious adverse events; All cause mortality

Outcome Measures

Primary Outcomes (4)

• Functional Outcome as Defined by a mRS of 0-2 at 90 Days Post-procedure

  Modified Rankin Scale (mRS) ranges from 0 to 5, with higher scores being worse.

  At 90 days post-procedure

• Angiographic Assessment of Vessel Patency as Measured by TIMI Score

  Defined by Number of participants with Thrombolysis in Myocardial Infarction (TIMI) 2-3. A lower score means a worse outcome and higher scores means better outcome on a scale of 0-3.

  At immediate post-procedure

• Angiographic Assessment of Vessel Patency as Measured by Modified TICI Score

  Defined by number of participants with modified thrombolysis in cerebral infarction (TICI) 2-3. A lower score means a worse outcome and higher scores means better outcome on a scale of 0-3.

  At immediate post-procedure

• Procedural Serious Adverse Events During the Procedure

  Defined by serious adverse events (SAEs) within 24 hours of the procedure

  During the procedure, approximately 24 hours

Secondary Outcomes (3)

• Good Neurological Recovery Post-procedure as Defined by a 10 Points or More Improvement on the NIHSS at Discharge

  At Discharge, an average of 7 days

• Incidence of Symptomatic and Asymptomatic Hemorrhage Based on the ECASS Criteria and Patient Neurological Status Within 24 Hours of the Procedure

  Within 24 hours of the procedure

• All Cause Mortality at 90 Days Post-procedure

  At 90 days post-procedure

Study Arms (1)

Penumbra Device Arm

EXPERIMENTAL

Device: Penumbra System

Interventions

Penumbra System DEVICE

The Penumbra System is used to revascularize clotted cerebral blood vessels.

Penumbra Device Arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Penumbra Inc.: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Ischemic Stroke; Stroke; Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Director of Clinical Affairs
• Organization: Penumbra, Inc.

blawson@penumbrainc.com

+1 510 995 2183

Study Officials

• Siu P Sit, PhD

  Penumbra Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2009
• First Posted: August 24, 2009
• Study Start: September 1, 2009
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: November 23, 2021
• Results First Posted: November 23, 2021

Record last verified: 2021-11

Locations

US (1)