COMPLETE: International Acute Ischemic Stroke Registry With the Penumbra System Aspiration Including the 3D Revascularization Device
- Conditions
- Stroke, Ischemic
- Interventions
- Device: Penumbra System
- Registration Number
- NCT03464565
- Lead Sponsor
- Penumbra Inc.
- Brief Summary
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).
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 650
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with acute ischemic stroke secondary to LVO Penumbra System -
- Primary Outcome Measures
Name Time Method Functional Subject Outcome 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.mTICI Score 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.All-cause mortality at 90 days 90 days All-cause mortality at 90 days
- Secondary Outcome Measures
Name Time Method Incidence of device and procedure related Serious Adverse Events (SAEs) Within 24 hours of procedure Discharge Facility Through discharge, up to study completion at approximately 90 days Time to Revascularization During Procedure Occurrence of symptomatic intracranial hemorrhages (sICH) 24 Hours Post Procedure Occurrence of embolization in previously uninvolved (or new) territories (ENT) During Procedure Occurrence of embolization in previously uninvolved (or new) territories (ENT) as seen on the final control angiogram at the end of procedure
Length of hospital stay Through discharge, up to study completion at approximately 90 days
Trial Locations
- Locations (42)
The Valley Hospital
🇺🇸Ridgewood, New Jersey, United States
Erlanger Health System
🇺🇸Chattanooga, Tennessee, United States
Methodist University Hospital
🇺🇸Memphis, Tennessee, United States
Samodzielny Publiczny Szpital Kliniczny
🇵🇱Lublin, Poland
Jackson Memorial Hospital
🇺🇸Miami, Florida, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
Cedar Sinai Medical Center
🇺🇸Los Angeles, California, United States
Mercy San Juan Medical Center
🇺🇸Sacramento, California, United States
Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States
AdventHealth Orlando
🇺🇸Orlando, Florida, United States
Banner Desert Medical Center
🇺🇸Mesa, Arizona, United States
Eden Medical Center
🇺🇸Castro Valley, California, United States
Los Robles Hospital
🇺🇸Thousand Oaks, California, United States
RIA
🇺🇸Englewood, Colorado, United States
Oschner Medical Center
🇺🇸New Orleans, Louisiana, United States
Naples Community Hospital
🇺🇸Naples, Florida, United States
Brigham & Women's Hospital
🇺🇸Boston, Massachusetts, United States
Mount Sinai New York
🇺🇸New York, New York, United States
Northwell Health
🇺🇸Manhasset, New York, United States
SSM St. Clare Healthcare
🇺🇸Saint Louis, Missouri, United States
Thomas Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Mercy St. Vincent Medical Center
🇺🇸Toledo, Ohio, United States
Palmetto Health Richland Hospital
🇺🇸Columbia, South Carolina, United States
NYU Langone Hospital-Brooklyn
🇺🇸New York, New York, United States
Valley Baptist Medical Center
🇺🇸Harlingen, Texas, United States
Fort Sanders Regional Medical Center
🇺🇸Knoxville, Tennessee, United States
Swedish Medical Center-Cherry Hill
🇺🇸Seattle, Washington, United States
CHU de Bordeaux - Hôpital Pellegrin
🇫🇷Bordeaux, France
McAllen Medical Center
🇺🇸McAllen, Texas, United States
Charité - Universitätsmedizin Berlin
🇩🇪Berlin, Germany
Klinikum Chemnitz gGmbH
🇩🇪Chemnitz, Germany
Universitätsklinikum Erlangen
🇩🇪Erlangen, Germany
Foundation Ophthalmic Adolphe De Rothschild
🇫🇷Paris, France
Universitätsklinikum Schleswig-Holstein Campus Lübeck
🇩🇪Lübeck, Germany
Universitätsklinikum Magdeburg A. ö. R.
🇩🇪Magdeburg, Germany
Davidovsky Moscow City Hospital №23
🇷🇺Moscow, Russian Federation
City Clinical Hospital No. 1
🇷🇺Moscow, Russian Federation
Hospital Clínico Universitario Virgen de la Arrixaca
🇪🇸Murcia, Spain
Multidisciplinary City Hospital №2
🇷🇺Saint Petersburg, Russian Federation
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
St. Jude Medical Center
🇺🇸Fullerton, California, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States