STRIKE-PE: A Prospective, Multicenter Study of the Indigo™ Aspiration System Seeking to Evaluate the Long-Term Safety and Outcomes of Treating Pulmonary Embolism
Status: Recruiting
Location: See all (71) locations...
Intervention Type: Device
Study Type: Observational
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Clinical signs and symptoms consistent with acute PE with duration of 14 days or less
• RV/LV ratio ≥ 0.9 assessed by diagnostic computed tomographic angiography (CTA) or echocardiogram
• Frontline endovascular treatment with the Indigo Aspiration System per IFU
• Patient is ≥ 18 years of age
• Informed consent obtained per Institutional Review Board/Ethics Committee requirements
Locations
United States
California
Long Beach Medical Center
RECRUITING
Long Beach
Cedars-Sinai Medical Center
RECRUITING
Los Angeles
UCLA Medical Center
RECRUITING
Los Angeles
UC Irvine Medical Center
RECRUITING
Orange
Sharp Memorial Hospital
RECRUITING
San Diego
Delaware
Christiana Care Hospital
RECRUITING
Newark
Florida
Manatee Memorial Hospital
RECRUITING
Bradenton
Blake Medical Center/Nova Clinical Research
RECRUITING
Brandenton
Delray Medical Center, Inc.
RECRUITING
Delray Beach
University of Florida Shands Hospital
RECRUITING
Gainesville
Radiology and Imaging Specialists
RECRUITING
Lakeland
Baptist Health Miami Cardiac and Vascular Institute
RECRUITING
Miami
Jackson Memorial Hospital
RECRUITING
Miami
AdventHealth Orlando
RECRUITING
Orlando
HCA Florida Northside Hospital
RECRUITING
Petersburg
St. Joseph Hospital - BayCare
RECRUITING
Tampa
Tampa General Hospital
RECRUITING
Tampa
Georgia
University Hospital Augusta
RECRUITING
Augusta
Illinois
Memorial Hospital Belleville
RECRUITING
Belleville
Loyola University Medical Center
RECRUITING
Maywood
Kansas
KUMC
COMPLETED
Kansas City
Louisiana
LSU Health Sciences Center
RECRUITING
Shreveport
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Charlton Memorial Hospital
RECRUITING
Fall River
Michigan
Ascension St. John Hospital
RECRUITING
Detroit
Minnesota
University of Minnesota
COMPLETED
Minneapolis
Missouri
Mercy Hospital South
RECRUITING
St Louis
Mississippi
University of Mississippi Medical Center
RECRUITING
Jackson
North Carolina
NC Heart and Vascular Research
RECRUITING
Raleigh
New Jersey
Cooper Health System
RECRUITING
Camden
New Mexico
Lovelace Health System
RECRUITING
Albuquerque
New York
Bellevue Hospital Center
RECRUITING
New York
Columbia University Medical Center/NYPH
RECRUITING
New York
Mount Sinai Hospital
RECRUITING
New York
St. Francis Hospital and Heart Center
RECRUITING
Roslyn
Staten Island University Hospital
RECRUITING
Staten Island
SUNY Upstate Medical University
RECRUITING
Syracuse
Ohio
Christ Hospital
COMPLETED
Cincinnati
TriHealth Good Samaritan Hospital
RECRUITING
Cincinnati
Mount Carmel East
RECRUITING
Columbus
Kettering Medical Center
RECRUITING
Kettering
ProMedica Toledo Hospital
RECRUITING
Toledo
Oklahoma
INTEGRIS Baptist Medical Center
RECRUITING
Oklahoma City
Hillcrest Medical Center
RECRUITING
Tulsa
Pennsylvania
UPMC Harrisburg
RECRUITING
Harrisburg
Temple University Hospital
RECRUITING
Philadelphia
Rhode Island
Miriam Hospital
RECRUITING
Providence
Tennessee
Jackson-Madison County General Hospital
RECRUITING
Jackson
Turkey Creek Medical Center
RECRUITING
Knoxville
Texas
Methodist Hospital Metropolitan
RECRUITING
San Antonio
Houston Methodist The Woodlands Hospital
RECRUITING
The Woodlands
Christus Mother Frances Hospital
RECRUITING
Tyler
Virginia
Sentara Norfolk General
RECRUITING
Norfolk
Wisconsin
Medical College of Wisconsin
RECRUITING
Milwaukee
Other Locations
Australia
Flinders Medical Centre
RECRUITING
Bedford Park
Brazil
Hospital Santa Lucia Sul
RECRUITING
Brasília
Germany
Universitätsmedizin Mannheim
RECRUITING
Mannheim
GRN-Klinik Weinheim
COMPLETED
Weinheim
Italy
Ospedale Misericordia
RECRUITING
Grosseto
Ospedale San Giovanni Bosco
RECRUITING
Torino
Netherlands
Leids Universitair Medisch Centrum
RECRUITING
Leiden
Poland
Krakowski Szpital Specjalistyczny św. Jana Pawła II
RECRUITING
Krakow
Europejskie Centrum Zdrowia Otwock
RECRUITING
Otwock
Uniwersytecki Szpital Kliniczny w Poznaniu
RECRUITING
Poznan
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
RECRUITING
Warsaw
Portugal
Hospital de Santa Cruz
RECRUITING
Carnaxide
Spain
Hospital Universitario Virgen de la Nieves
RECRUITING
Granada
Hospital Clínico Universitario Lozano Blesa
RECRUITING
Zaragoza
United Kingdom
Royal Sussex County Hospital
RECRUITING
Brighton
University Hospital of Wales
RECRUITING
Cardiff
Royal Free Hospital
RECRUITING
London
Contact Information
Primary
Joanne Krasnoff
jkrasnoff@penumbrainc.com
650-455-4462
Backup
Aisha Pascua
apascua@penumbrainc.com
415-601-9561
Time Frame
Start Date: 2021-06-25
Estimated Completion Date: 2028-02
Participants
Target number of participants: 1500
Treatments
Patients with acute pulmonary embolism
Related Therapeutic Areas
Sponsors
Leads: Penumbra Inc.