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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Long Beach Medical Center
  Long Beach, California, United States Recruiting
• Cedars-Sinai Medical Center
  Los Angeles, California, United States Recruiting
• UCLA Medical Center
  Los Angeles, California, United States Recruiting
• UC Irvine Medical Center
  Orange, California, United States Recruiting
• UCSD Jacobs
  San Diego, California, United States Recruiting
• Sharp Memorial Hospital
  San Diego, California, United States Recruiting

+29 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: John Moriarty, MD — University of California, Los Angeles
• Study coordinator: Joanne Krasnoff
• Email: jkrasnoff@penumbrainc.com
• Phone: 650-455-4462

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.