What this study is
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).
What's being tested
- Indigo Aspiration System
Intervention · DEVICE
Indigo Aspiration System
Study details
- 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
- Sponsor
- Penumbra Inc.
- Conditions
- Pulmonary Embolism
- Enrolling
- 1,500 people
- Starts
- 2021-06-25
- Est. completion
- 2028-02
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- Contraindication to systemic or therapeutic doses of anticoagulants (e.g. heparin)
- Stage IV (metastatic) cancer, active lung cancer or previous history of surgery in the affected lung(s) or chest radiation
- Known serious, uncontrolled sensitivity to radiographic agents
- Life expectancy < 180 days
- Patients on ECMO
- Pregnant patients
- Current participation in another investigational drug or device study that may confound the results of this study. Studies requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational studies
- Other medical, social, or psychological conditions that, in the opinion of the Investigator, precludes the patient from appropriate consent, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (79)
74 openLong Beach Medical Center
Long Beach, California, United States
RecruitingCedars-Sinai Medical Center
Los Angeles, California, United States
RecruitingUCLA Medical Center
Los Angeles, California, United States
RecruitingUC Irvine Medical Center
Orange, California, United States
RecruitingUCSD Jacobs
San Diego, California, United States
RecruitingSharp Memorial Hospital
San Diego, California, United States
RecruitingChristiana Care Hospital
Newark, Delaware, United States
RecruitingMedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
RecruitingManatee Memorial Hospital
Bradenton, Florida, United States
RecruitingBlake Medical Center/Nova Clinical Research
Brandenton, Florida, United States
RecruitingDelray Medical Center, Inc.
Delray Beach, Florida, United States
RecruitingUniversity of Florida Shands Hospital
Gainesville, Florida, United States
RecruitingRadiology and Imaging Specialists
Lakeland, Florida, United States
RecruitingJackson Memorial Hospital
Miami, Florida, United States
RecruitingBaptist Health Miami Cardiac and Vascular Institute
Miami, Florida, United States
RecruitingAdventHealth Orlando
Orlando, Florida, United States
RecruitingHCA Florida Northside Hospital
Petersburg, Florida, United States
RecruitingTampa General Hospital
Tampa, Florida, United States
RecruitingSt. Joseph Hospital - BayCare
Tampa, Florida, United States
RecruitingUniversity Hospital Augusta
Augusta, Georgia, United States
RecruitingMemorial Hospital Belleville
Belleville, Illinois, United States
RecruitingGlenbrook Hospital
Glenview, Illinois, United States
RecruitingLoyola University Medical Center
Maywood, Illinois, United States
RecruitingLSU Health Sciences Center
Shreveport, Louisiana, United States
RecruitingMassachusetts General Hospital
Boston, Massachusetts, United States
RecruitingCharlton Memorial Hospital
Fall River, Massachusetts, United States
RecruitingAscension St. John Hospital
Detroit, Michigan, United States
RecruitingUniversity of Mississippi Medical Center
Jackson, Mississippi, United States
RecruitingMercy Hospital South
St Louis, Missouri, United States
RecruitingCooper Health System
Camden, New Jersey, United States
RecruitingLovelace Health System
Albuquerque, New Mexico, United States
RecruitingBellevue Hospital Center
New York, New York, United States
RecruitingMount Sinai Hospital
New York, New York, United States
RecruitingColumbia University Medical Center/NYPH
New York, New York, United States
RecruitingSt. Francis Hospital and Heart Center
Roslyn, New York, United States
RecruitingStaten Island University Hospital
Staten Island, New York, United States
RecruitingSUNY Upstate Medical University
Syracuse, New York, United States
RecruitingNC Heart and Vascular Research
Raleigh, North Carolina, United States
RecruitingTriHealth Good Samaritan Hospital
Cincinnati, Ohio, United States
RecruitingMount Carmel East
Columbus, Ohio, United States
RecruitingKettering Medical Center
Kettering, Ohio, United States
RecruitingProMedica Toledo Hospital
Toledo, Ohio, United States
RecruitingINTEGRIS Baptist Medical Center
Oklahoma City, Oklahoma, United States
RecruitingHillcrest Medical Center
Tulsa, Oklahoma, United States
RecruitingUPMC Harrisburg
Harrisburg, Pennsylvania, United States
RecruitingPenn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
RecruitingTemple University Hospital
Philadelphia, Pennsylvania, United States
RecruitingMiriam Hospital
Providence, Rhode Island, United States
RecruitingJackson-Madison County General Hospital
Jackson, Tennessee, United States
RecruitingTurkey Creek Medical Center
Knoxville, Tennessee, United States
RecruitingMethodist Hospital Metropolitan
San Antonio, Texas, United States
RecruitingHouston Methodist The Woodlands Hospital
The Woodlands, Texas, United States
RecruitingChristus Mother Frances Hospital
Tyler, Texas, United States
RecruitingSentara Norfolk General
Norfolk, Virginia, United States
RecruitingMedical College of Wisconsin
Milwaukee, Wisconsin, United States
RecruitingKUMC
Kansas City, Kansas, United States
CompletedUniversity of Minnesota
Minneapolis, Minnesota, United States
CompletedChrist Hospital
Cincinnati, Ohio, United States
Completed
21 sites outside the US
Westmead Hospital
Westmead, New South Wales, Australia
RecruitingFlinders Medical Centre
Bedford Park, South Australia, Australia
RecruitingMedUni Graz-Univ.-Klinikum Graz
Graz, Austria
RecruitingHospital Santa Lucia Sul
Brasília, Brazil
RecruitingUniversitätsmedizin Mannheim
Mannheim, Baden-Wurttemberg, Germany
RecruitingUniversitaetsmedizin Mainz
Mainz, Germany
RecruitingOspedale Misericordia
Grosseto, Italy
RecruitingOspedale San Giovanni Bosco
Torino, Italy
RecruitingLeids Universitair Medisch Centrum
Leiden, Netherlands
RecruitingKrakowski Szpital Specjalistyczny św. Jana Pawła II
Krakow, Poland
RecruitingEuropejskie Centrum Zdrowia Otwock
Otwock, Poland
RecruitingUniwersytecki Szpital Kliniczny w Poznaniu
Poznan, Poland
RecruitingUniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Warsaw, Poland
RecruitingHospital de Santa Cruz
Carnaxide, Portugal
RecruitingHospital Universitario Virgen de la Nieves
Granada, Spain
RecruitingHospital Clínico Universitario Lozano Blesa
Zaragoza, Spain
RecruitingInselspital, Universitätsspital Bern
Bern, Switzerland
RecruitingRoyal Sussex County Hospital
Brighton, Sussex, United Kingdom
RecruitingRoyal Free Hospital
London, United Kingdom
RecruitingGRN-Klinik Weinheim
Weinheim, Germany
CompletedUniversity Hospital of Wales
Cardiff, Wales, United Kingdom
Completed
Study team
Sponsor
Penumbra Inc.
Study ID 18135
Principal investigator
John Moriarty, MD
University of California, Los Angeles
Principal investigator
Aleksander Araszkiewicz, MD, PhD
Uniwersytecki Szpital Kliniczny w Poznaniu
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.