RECRUITING

Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System

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Conditions

Pulmonary Embolism

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2021-06-25
Study Completion:2028-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04798261

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Clinical signs and symptoms consistent with acute PE with duration of 14 days or less
  2. 2. RV/LV ratio ≥ 0.9 assessed by diagnostic computed tomographic angiography (CTA) or echocardiogram
  3. 3. Frontline endovascular treatment with the Indigo Aspiration System per IFU
  4. 4. Patient is ≥ 18 years of age
  5. 5. Informed consent obtained per Institutional Review Board/Ethics Committee requirements
  1. 1. Contraindication to systemic or therapeutic doses of anticoagulants (e.g. heparin)
  2. 2. Stage IV (metastatic) cancer, active lung cancer or previous history of surgery in the affected lung(s) or chest radiation
  3. 3. Known serious, uncontrolled sensitivity to radiographic agents
  4. 4. Life expectancy \< 180 days
  5. 5. Patients on ECMO
  6. 6. Pregnant patients
  7. 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. 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

Contacts and Locations

Study Contact

Joanne Krasnoff
CONTACT
650-455-4462
jkrasnoff@penumbrainc.com
Aisha Pascua
CONTACT
415-601-9561
apascua@penumbrainc.com

Principal Investigator

John Moriarty, MD
PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Andrew Sharp, MD
PRINCIPAL_INVESTIGATOR
University College Dublin and The Mater Misericordiae Hospital

Study Locations (Sites)

Long Beach Medical Center
Long Beach, California, 90806
United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
UCLA Medical Center
Los Angeles, California, 90095
United States
Sharp Memorial Hospital
San Diego, California, 92123
United States
Manatee Memorial Hospital
Bradenton, Florida, 34205
United States
Blake Medical Center/Nova Clinical Research
Bradenton, Florida, 34209
United States
University of Florida Shands Hospital
Gainesville, Florida, 32608
United States
Radiology and Imaging Specialists
Lakeland, Florida, 33805
United States
Jackson Memorial Hospital
Miami, Florida, 33136
United States
Baptist Health Miami Cardiac and Vascular Institute
Miami, Florida, 33176
United States
AdventHealth Orlando
Orlando, Florida, 32803
United States
St. Joseph Hospital - BayCare
Tampa, Florida, 33614
United States
University Hospital Augusta
Augusta, Georgia, 30901
United States
Loyola University Medical Center
Maywood, Illinois, 600153
United States
KUMC
Kansas City, Kansas, 66160
United States
LSU Health Sciences Center
Shreveport, Louisiana, 71103
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Charlton Memorial Hospital
Fall River, Massachusetts, 02720
United States
Ascension St. John Hospital
Detroit, Michigan, 48236
United States
University of Minnesota
Minneapolis, Minnesota, 55455
United States
Mercy Hospital South
Saint Louis, Missouri, 63128
United States
Cooper Health System
Camden, New Jersey, 08103
United States
Lovelace Health System
Albuquerque, New Mexico, 87102
United States
Bellevue Hospital Center
New York, New York, 10016
United States
Mount Sinai Hospital
New York, New York, 10029
United States
Columbia University Medical Center/NYPH
New York, New York, 10032
United States
St. Francis Hospital and Heart Center
Roslyn, New York, 11576
United States
Staten Island University Hospital
Staten Island, New York, 10305
United States
SUNY Upstate Medical University
Syracuse, New York, 13210
United States
NC Heart and Vascular Research
Raleigh, North Carolina, 27607
United States
Christ Hospital
Cincinnati, Ohio, 45219
United States
TriHealth Good Samaritan Hospital
Cincinnati, Ohio, 45220
United States
Kettering Medical Center
Kettering, Ohio, 45429
United States
INTEGRIS Baptist Medical Center
Oklahoma City, Oklahoma, 73112
United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140
United States
Miriam Hospital
Providence, Rhode Island, 02903
United States
Sentara Norfolk General
Norfolk, Virginia, 23507
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Penumbra Inc.

  • John Moriarty, MD, PRINCIPAL_INVESTIGATOR, University of California, Los Angeles
  • Andrew Sharp, MD, PRINCIPAL_INVESTIGATOR, University College Dublin and The Mater Misericordiae Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-06-25
Study Completion Date2028-02

Study Record Updates

Study Start Date2021-06-25
Study Completion Date2028-02

Terms related to this study

Additional Relevant MeSH Terms

  • Pulmonary Embolism