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

  • End date
    Mar 3, 2026
  • participants needed
  • sponsor
    Penumbra Inc.
Updated on 4 October 2022
computed tomography angiography


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).

Condition lung embolism, Pulmonary Disease, Lung Disease, Pulmonary Embolism
Treatment Indigo Aspiration System
Clinical Study IdentifierNCT04798261
SponsorPenumbra Inc.
Last Modified on4 October 2022


Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

Contraindication to systemic or therapeutic doses of anticoagulants (e.g. heparin)
Stage III/IV cancer or cancer which requires active chemotherapy during the course of the study
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
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What happens next?
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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