Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System
NCT ID: NCT04798261
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1500 participants
OBSERVATIONAL
2021-06-25
2028-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with acute pulmonary embolism
Indigo Aspiration System
Indigo Aspiration System
Interventions
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Indigo Aspiration System
Indigo Aspiration System
Eligibility Criteria
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Inclusion Criteria
2. RV/LV ratio ≥ 0.9 assessed by diagnostic computed tomographic angiography (CTA) or echocardiogram
3. Frontline endovascular treatment with the Indigo Aspiration System per IFU
4. Patient is ≥ 18 years of age
5. Informed consent obtained per Institutional Review Board/Ethics Committee requirements
Exclusion Criteria
2. Stage IV (metastatic) cancer, active lung cancer or previous history of surgery in the affected lung(s) or chest radiation
3. Known serious, uncontrolled sensitivity to radiographic agents
4. Life expectancy \< 180 days
5. Patients on ECMO
6. Pregnant patients
7. 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
8. 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
18 Years
ALL
No
Sponsors
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Penumbra Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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John Moriarty, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Andrew Sharp, MD
Role: PRINCIPAL_INVESTIGATOR
University College Dublin and The Mater Misericordiae Hospital
Locations
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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
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
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
Temple University Hospital
Philadelphia, Pennsylvania, United States
Miriam Hospital
Providence, Rhode Island, 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
Royal Sussex County Hospital
Brighton, Sussex, United Kingdom
University Hospital of Wales
Cardiff, Wales, United Kingdom
Royal Free Hospital
London, , United Kingdom
Countries
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Central Contacts
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References
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Moriarty JM, Schiro BJ, Dohad SY, Tamaddon H, Davis HC, Shavelle DM, Chrysant GS, Iliadis EA, Dexter DJ 2nd, Ciampi Dopazo JJ, Holden A, West FM, Keeling B, Sharp ASP, Weinberg I. Periprocedural Results and Right Ventricular Outcomes of Computer Assisted Vacuum Thrombectomy Treatment of Acute Pulmonary Embolism: Interim Analysis of 300 Patients From the STRIKE-PE Study. J Am Heart Assoc. 2025 Sep 2;14(17):e039975. doi: 10.1161/JAHA.124.039975. Epub 2025 Aug 29.
Other Identifiers
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18135
Identifier Type: -
Identifier Source: org_study_id