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Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System
Sponsor: Penumbra Inc.
Summary
The objective of this study is to evaluate real world long-term functional outcomes, safety and performance of the Indigo Aspiration System for the treatment of pulmonary embolism (PE).
Official title: STRIKE-PE: A Prospective, Multicenter Study of the Indigo™ Aspiration System Seeking to Evaluate the Long-Term Safety and Outcomes of Treating Pulmonary Embolism
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
1500
Start Date
2021-06-25
Completion Date
2028-02
Last Updated
2026-02-23
Healthy Volunteers
No
Conditions
Interventions
Indigo Aspiration System
Indigo Aspiration System
Locations (72)
Long Beach Medical Center
Long Beach, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
UCLA Medical Center
Los Angeles, California, United States
UC Irvine Medical Center
Orange, California, United States
Sharp Memorial Hospital
San Diego, California, United States
Christiana Care Hospital
Newark, Delaware, United States
Manatee Memorial Hospital
Bradenton, Florida, United States
Blake Medical Center/Nova Clinical Research
Brandenton, Florida, United States
Delray Medical Center, Inc.
Delray Beach, Florida, United States
University of Florida Shands Hospital
Gainesville, Florida, United States
Radiology and Imaging Specialists
Lakeland, Florida, United States
Jackson Memorial Hospital
Miami, Florida, United States
Baptist Health Miami Cardiac and Vascular Institute
Miami, Florida, United States
AdventHealth Orlando
Orlando, Florida, United States
HCA Florida Northside Hospital
Petersburg, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
St. Joseph Hospital - BayCare
Tampa, Florida, United States
University Hospital Augusta
Augusta, Georgia, United States
Memorial Hospital Belleville
Belleville, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
KUMC
Kansas City, Kansas, United States
LSU Health Sciences Center
Shreveport, Louisiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Charlton Memorial Hospital
Fall River, Massachusetts, United States
Ascension St. John Hospital
Detroit, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Mercy Hospital South
St Louis, Missouri, United States
Cooper Health System
Camden, New Jersey, United States
Lovelace Health System
Albuquerque, New Mexico, United States
Bellevue Hospital Center
New York, New York, United States
Mount Sinai Hospital
New York, New York, United States
Columbia University Medical Center/NYPH
New York, New York, United States
St. Francis Hospital and Heart Center
Roslyn, New York, United States
Staten Island University Hospital
Staten Island, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
NC Heart and Vascular Research
Raleigh, North Carolina, United States
Christ Hospital
Cincinnati, Ohio, United States
TriHealth Good Samaritan Hospital
Cincinnati, Ohio, United States
Mount Carmel East
Columbus, Ohio, United States
Kettering Medical Center
Kettering, Ohio, United States
ProMedica Toledo Hospital
Toledo, Ohio, United States
INTEGRIS Baptist Medical Center
Oklahoma City, Oklahoma, United States
Hillcrest Medical Center
Tulsa, Oklahoma, United States
UPMC Harrisburg
Harrisburg, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Miriam Hospital
Providence, Rhode Island, United States
Jackson-Madison County General Hospital
Jackson, Tennessee, United States
Turkey Creek Medical Center
Knoxville, Tennessee, United States
Methodist Hospital Metropolitan
San Antonio, Texas, United States
Houston Methodist The Woodlands Hospital
The Woodlands, Texas, United States
Christus Mother Frances Hospital
Tyler, Texas, United States
Sentara Norfolk General
Norfolk, Virginia, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Flinders Medical Centre
Bedford Park, South Australia, Australia
Hospital Santa Lucia Sul
Brasília, Brazil
Universitätsmedizin Mannheim
Mannheim, Baden-Wurttemberg, Germany
GRN-Klinik Weinheim
Weinheim, Germany
Ospedale Misericordia
Grosseto, Italy
Ospedale San Giovanni Bosco
Torino, Italy
Leids Universitair Medisch Centrum
Leiden, Netherlands
Krakowski Szpital Specjalistyczny św. Jana Pawła II
Krakow, Poland
Europejskie Centrum Zdrowia Otwock
Otwock, Poland
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, Poland
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Warsaw, Poland
Hospital de Santa Cruz
Carnaxide, Portugal
Hospital Universitario Virgen de la Nieves
Granada, Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Spain
Inselspital, Universitätsspital Bern
Bern, Switzerland
Royal Sussex County Hospital
Brighton, Sussex, United Kingdom
University Hospital of Wales
Cardiff, Wales, United Kingdom
Royal Free Hospital
London, United Kingdom