COMPLETE: International Acute Ischemic Stroke Registry With the Penumbra System Aspiration Including the 3D Revascularization Device

December 18, 2020 updated by: Penumbra Inc.
The purpose of this registry is to collect performance and safety data on the Penumbra System including the 3D Revascularization Device in a real world patient population with acute ischemic stroke (AIS) secondary to intracranial large vessel occlusion (LVO).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Registry Objective: The primary objective of this registry is to collect real-world performance and safety data on Penumbra System including the 3D Revascularization Device in a patient population with acute ischemic stroke (AIS) secondary to intracranial large vessel occlusion (LVO).

Registry Design: This will be a prospective, single-arm, multi-center observational registry and will include patients that present with either anterior or posterior LVO who are eligible for mechanical thrombectomy using the Penumbra System.

Registry Duration: Subjects will be in the registry for approximately 90 days from enrollment to last follow-up.

Study Type

Observational

Enrollment (Actual)

650

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33000
        • CHU de Bordeaux - Hôpital Pellegrin
      • Paris, France, 75019
        • Foundation Ophthalmic Adolphe De Rothschild
  • Germany
      • Berlin, Germany, 10117
        • Charité - Universitätsmedizin Berlin
      • Chemnitz, Germany, 09116
        • Klinikum Chemnitz gGmbH
      • Erlangen, Germany, 91054
        • Universitätsklinikum Erlangen
      • Lübeck, Germany, 23538
        • Universitätsklinikum Schleswig-Holstein Campus Lübeck
      • Magdeburg, Germany, 39120
        • Universitätsklinikum Magdeburg A. ö. R.
  • Poland
      • Lublin, Poland, 20 - 954
        • Samodzielny Publiczny Szpital Kliniczny
  • Russian Federation
      • Moscow, Russian Federation, 109240
        • Davidovsky Moscow City Hospital №23
      • Moscow, Russian Federation, 119049
        • City Clinical Hospital No. 1
      • Saint Petersburg, Russian Federation, 194354
        • Multidisciplinary City Hospital №2
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Murcia, Spain, 30120
        • Hospital Clinico Universitario Virgen de la Arrixaca
  • United States
    • Arizona
      • Mesa, Arizona, United States, 85202
        • Banner Desert Medical Center
    • California
      • Castro Valley, California, United States, 94546
        • Eden Medical Center
      • Fullerton, California, United States, 92835
        • St. Jude Medical Center
      • Los Angeles, California, United States, 90048
        • Cedar Sinai Medical Center
      • Sacramento, California, United States, 95608
        • Mercy San Juan Medical Center
      • Thousand Oaks, California, United States, 91360
        • Los Robles Hospital
    • Colorado
      • Englewood, Colorado, United States, 80112
        • RIA
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Yale New Haven Hospital
    • Florida
      • Miami, Florida, United States, 33136
        • Jackson Memorial Hospital
      • Naples, Florida, United States, 34102
        • Naples Community Hospital
      • Orlando, Florida, United States, 32803
        • AdventHealth Orlando
    • Kansas
      • Kansas City, Kansas, United States, 66106
        • University of Kansas Medical Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Oschner Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham & Women's Hospital
    • Missouri
      • Saint Louis, Missouri, United States, 63026
        • SSM St. Clare Healthcare
    • New Jersey
      • Ridgewood, New Jersey, United States, 07450
        • The Valley Hospital
    • New York
      • Manhasset, New York, United States, 11042
        • Northwell Health
      • New York, New York, United States, 10029
        • Mount Sinai New York
      • New York, New York, United States, 11220
        • NYU Langone Hospital-Brooklyn
    • Ohio
      • Toledo, Ohio, United States, 43608
        • Mercy St. Vincent Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • Palmetto Health Richland Hospital
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Erlanger Health System
      • Knoxville, Tennessee, United States, 37916
        • Fort Sanders Regional Medical Center
      • Memphis, Tennessee, United States, 38104
        • Methodist University Hospital
    • Texas
      • Harlingen, Texas, United States, 78550
        • Valley Baptist Medical Center
      • Houston, Texas, United States, 77030
        • Houston Methodist Hospital
      • McAllen, Texas, United States, 78503
        • McAllen Medical Center
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish Medical Center-Cherry Hill

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients experiencing acute ischemic stroke secondary to intracranial large vessel occlusion who are eligible for mechanical thrombectomy using the Penumbra System

Description

Inclusion Criteria:

  • Patient age ≥ 18
  • Pre-stroke mRS 0-1
  • Patient experiencing acute ischemic stroke secondary to intracranial large vessel occlusion who are eligible for mechanical thrombectomy using the Penumbra System
  • Planned frontline treatment with Penumbra System
  • Signed informed consent per Institution Review Board/Ethics Committee

Exclusion Criteria:

  • Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments through 90 days.
  • Currently participating in an investigational (drug, device, etc) clinical trial that will confound study endpoints. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with acute ischemic stroke secondary to LVO
Device: Penumbra System
Penumbra System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mTICI Score
Time Frame: Post Procedure

Angiographic revascularization of the occluded target vessel at immediate post-procedure as defined by a modified treatment in cerebral infarction (mTICI) score 2b or higher.

mTICI scale ranges 0 to 3 higher values represent better outcomes.
Post Procedure
Functional Subject Outcome
Time Frame: 90 days post

Functional subject outcome at 90 days post-procedure as defined by a modified Rankin Scale (mRS) 0-2.

mRS scale ranges 0 to 6 higher values represent a worse outcome.
90 days post
All-cause mortality at 90 days
Time Frame: 90 days
All-cause mortality at 90 days
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of device and procedure related Serious Adverse Events (SAEs)
Time Frame: Within 24 hours of procedure
Within 24 hours of procedure
Occurrence of embolization in previously uninvolved (or new) territories (ENT)
Time Frame: During Procedure
Occurrence of embolization in previously uninvolved (or new) territories (ENT) as seen on the final control angiogram at the end of procedure
During Procedure
Occurrence of symptomatic intracranial hemorrhages (sICH)
Time Frame: 24 Hours Post Procedure
24 Hours Post Procedure
Time to Revascularization
Time Frame: During Procedure
During Procedure
Length of hospital stay
Time Frame: Through discharge, up to study completion at approximately 90 days
Through discharge, up to study completion at approximately 90 days
Discharge Facility
Time Frame: Through discharge, up to study completion at approximately 90 days
Through discharge, up to study completion at approximately 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Penumbra Inc.

Investigators

  • Principal Investigator: Osama O Zaidat, MD, Mercy St. Vincent Medical Center
  • Principal Investigator: Johanna Fifi, MD, Mount Sinai Health System
  • Principal Investigator: Ameer E. Hassan, MD, McAllen Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 2, 2018

Primary Completion (Actual)

January 17, 2020

Study Completion (Actual)

January 17, 2020

Study Registration Dates

First Submitted

March 7, 2018

First Submitted That Met QC Criteria

March 7, 2018

First Posted (Actual)

March 14, 2018

Study Record Updates

Last Update Posted (Actual)

December 22, 2020

Last Update Submitted That Met QC Criteria

December 18, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12965

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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