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

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NCT04798261 · readout ≤ 134 d

Sponsored by Penumbra Inc. (industry) · PEN — their whole pipeline →.

Phase
Status
Recruiting
Study type
Observational
Enrollment
1,500estimated
Sites
79
Countries
Australia, Austria, Brazil +9

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2021-06-25actualWhen the study began enrolling
Primary completionDec 2026estimatedThe date the last participant is measured for the primary outcome — the readout window
Study completionFeb 2028estimatedThe whole study's end, after follow-up
First posted2021-03-15actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2026-07-06actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

  • Pulmonary Embolism

Intervention

  • Device: Indigo Aspiration System

Primary outcomes

what the primary-completion date above is the date OF
Safety: Composite of major adverse events
measured 48 hours
Performance: Change in RV/LV Ratio
measured 48 hours post-procedure

Publications

Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.

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