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

  • STATUS
    Recruiting
  • End date
    Mar 3, 2026
  • participants needed
    600
  • sponsor
    Penumbra Inc.
Updated on 4 October 2022
angiography
computed tomography angiography

Summary

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).

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

Eligibility

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

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.

Learn more

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

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note