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

Completed

Conditions studied: Stroke, Ischemic

In brief

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).

Key facts

Study ID

NCT03464565

Run by

Penumbra Inc.

People needed

650

Starts

2018-07-02

Expected to finish

2020-01-17

Last updated by the study team

2020-12-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Banner Desert Medical Center — Mesa, Arizona, United States
• Eden Medical Center — Castro Valley, California, United States
• St. Jude Medical Center — Fullerton, California, United States
• Cedar Sinai Medical Center — Los Angeles, California, United States
• Mercy San Juan Medical Center — Sacramento, California, United States
• Los Robles Hospital — Thousand Oaks, California, United States
• RIA — Englewood, Colorado, United States
• Yale New Haven Hospital — New Haven, Connecticut, United States
• Jackson Memorial Hospital — Miami, Florida, United States
• Naples Community Hospital — Naples, Florida, United States
• AdventHealth Orlando — Orlando, Florida, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Oschner Medical Center — New Orleans, Louisiana, United States
• Brigham & Women's Hospital — Boston, Massachusetts, United States
• SSM St. Clare Healthcare — St Louis, Missouri, United States
• The Valley Hospital — Ridgewood, New Jersey, United States
• Northwell Health — Manhasset, New York, United States
• Mount Sinai New York — New York, New York, United States
• NYU Langone Hospital-Brooklyn — New York, New York, United States
• Mercy St. Vincent Medical Center — Toledo, Ohio, United States
• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
• Palmetto Health Richland Hospital — Columbia, South Carolina, United States
• Erlanger Health System — Chattanooga, Tennessee, United States
• Fort Sanders Regional Medical Center — Knoxville, Tennessee, United States
• Methodist University Hospital — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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