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

Recruiting now

Conditions studied: Pulmonary Embolism

In brief

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).

Key facts

Study ID

NCT04798261

Run by

Penumbra Inc.

People needed

1500

Starts

2021-06-25

Expected to finish

2028-02-01

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Contraindication to systemic or therapeutic doses of anticoagulants (e.g. heparin)
• Stage IV (metastatic) cancer, active lung cancer or previous history of surgery in the affected lung(s) or chest radiation
• 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

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
• Long Beach Medical Center — Long Beach, California, United States (enrolling)
• UC Irvine Medical Center — Orange, California, United States (enrolling)
• UCSD Jacobs — San Diego, California, United States (enrolling)
• UCLA Medical Center — Los Angeles, California, United States (enrolling)
• Christiana Care Hospital — Newark, Delaware, United States (enrolling)
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States (enrolling)
• Manatee Memorial Hospital — Bradenton, Florida, United States (enrolling)
• Blake Medical Center/Nova Clinical Research — Brandenton, Florida, United States (enrolling)
• Delray Medical Center, Inc. — Delray Beach, Florida, United States (enrolling)
• Sharp Memorial Hospital — San Diego, California, United States (enrolling)
• Radiology and Imaging Specialists — Lakeland, Florida, United States (enrolling)
• Jackson Memorial Hospital — Miami, Florida, United States (enrolling)
• Baptist Health Miami Cardiac and Vascular Institute — Miami, Florida, United States (enrolling)
• AdventHealth Orlando — Orlando, Florida, United States (enrolling)
• HCA Florida Northside Hospital — Petersburg, Florida, United States (enrolling)
• Tampa General Hospital — Tampa, Florida, United States (enrolling)
• St. Joseph Hospital - BayCare — Tampa, Florida, United States (enrolling)
• University Hospital Augusta — Augusta, Georgia, United States (enrolling)
• Memorial Hospital Belleville — Belleville, Illinois, United States (enrolling)
• Glenbrook Hospital — Glenview, Illinois, United States (enrolling)
• Loyola University Medical Center — Maywood, Illinois, United States (enrolling)
• University of Florida Shands Hospital — Gainesville, Florida, United States (enrolling)
• LSU Health Sciences Center — Shreveport, Louisiana, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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