Recruiting OBSERVATIONAL NCT04798261

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

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

Sponsor: Penumbra Inc.

Conditions Pulmonary Embolism

Interventions Indigo Aspiration System

Updated 27 times since 2021 Last updated: Apr 9, 2026 Started: Jun 25, 2021 Primary completion: Dec 1, 2026 Completion: Feb 1, 2028

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A observational or N/A phase clinical study on Pulmonary Embolism, this trial is actively recruiting participants. The trial is conducted by Penumbra Inc. and has accumulated 27 data snapshots since 2021. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

Change History

27 versions recorded

Apr 16, 2026 — Present [daily]

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First recorded

Eligibility 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).

Contact Information

Sponsor contact:

Penumbra Inc.

Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Albuquerque, United States , Augusta, United States , Bedford Park, Australia , Belleville, United States , Bern, Switzerland , Boston, United States , Bradenton, United States , Brandenton, United States , Brasília, Brazil , Brighton, United Kingdom and 64 more locations