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

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).

Conditions

Pulmonary Embolism

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Study Overview

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Study Details

Study overview

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).

STRIKE-PE: A Prospective, Multicenter Study of the Indigo™ Aspiration System Seeking to Evaluate the Long-Term Safety and Outcomes of Treating Pulmonary Embolism

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

Condition
Pulmonary Embolism
Intervention / Treatment

-

Contacts and Locations

Long Beach

Long Beach Medical Center, Long Beach, California, United States, 90806

Los Angeles

Cedars-Sinai Medical Center, Los Angeles, California, United States, 90048

Los Angeles

UCLA Medical Center, Los Angeles, California, United States, 90095

San Diego

Sharp Memorial Hospital, San Diego, California, United States, 92123

Bradenton

Manatee Memorial Hospital, Bradenton, Florida, United States, 34205

Bradenton

Blake Medical Center/Nova Clinical Research, Bradenton, Florida, United States, 34209

Gainesville

University of Florida Shands Hospital, Gainesville, Florida, United States, 32608

Lakeland

Radiology and Imaging Specialists, Lakeland, Florida, United States, 33805

Miami

Jackson Memorial Hospital, Miami, Florida, United States, 33136

Miami

Baptist Health Miami Cardiac and Vascular Institute, Miami, Florida, United States, 33176

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Clinical signs and symptoms consistent with acute PE with duration of 14 days or less
  • 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
  • 1. Contraindication to systemic or therapeutic doses of anticoagulants (e.g. heparin)
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

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

2028-02