Home › Trials › NCT04798261

Evaluating the long-term safety and outcomes of the Indigo Aspiration System for pulmonary embolism treatment

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

Penumbra Inc. · NCT04798261

This study is testing how safe and effective the Indigo Aspiration System is for treating pulmonary embolism in patients over the long term.

Quick facts

Study typeObservational
Enrollment1500 (estimated)
Ages18 Years and up
SexAll
SponsorPenumbra Inc. (industry)
Drugs / interventionsradiation
Locations74 sites (Long Beach, California and 73 other locations)
Trial IDNCT04798261 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the long-term functional outcomes, safety, and performance of the Indigo Aspiration System in treating pulmonary embolism (PE). It includes patients who exhibit clinical signs of acute PE and have a specific RV/LV ratio, ensuring they receive frontline endovascular treatment with the device. The study will gather real-world data to evaluate how effective and safe this treatment is over time.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with acute pulmonary embolism symptoms lasting 14 days or less and a specific RV/LV ratio.

Not a fit: Patients with contraindications to anticoagulants, severe cancer, or those with a life expectancy of less than 180 days may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term safety and effectiveness of a novel treatment for pulmonary embolism.

How similar studies have performed: While this study focuses on a specific device, similar approaches in evaluating endovascular treatments for pulmonary embolism have shown promise in the past.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion 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

Exclusion Criteria:

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

Where this trial is running

Long Beach, California and 73 other locations

+24 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Pulmonary Embolism

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.