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Clinical Trials in the USA / NCT04798261
Recruiting Observational

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

NCT04798261 · tracked via the Priya Life Science USA tracker
Sponsor
Penumbra Inc.
Phase
Observational
Started
2021-06-25
Last updated
2026-07-06

Condition(s) studied

Pulmonary Embolism

Investigational drug(s) / intervention(s)

Indigo Aspiration System

Indigo Aspiration System: Indigo Aspiration System

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (79)

FacilityCityRegionStatus
Long Beach Medical Center Long Beach California Recruiting
Cedars-Sinai Medical Center Los Angeles California Recruiting
UCLA Medical Center Los Angeles California Recruiting
UC Irvine Medical Center Orange California Recruiting
UCSD Jacobs San Diego California Recruiting
Sharp Memorial Hospital San Diego California Recruiting
Christiana Care Hospital Newark Delaware Recruiting
MedStar Washington Hospital Center Washington D.C. District of Columbia Recruiting
Manatee Memorial Hospital Bradenton Florida Recruiting
Blake Medical Center/Nova Clinical Research Brandenton Florida Recruiting
Delray Medical Center, Inc. Delray Beach Florida Recruiting
University of Florida Shands Hospital Gainesville Florida Recruiting
Radiology and Imaging Specialists Lakeland Florida Recruiting
Jackson Memorial Hospital Miami Florida Recruiting
Baptist Health Miami Cardiac and Vascular Institute Miami Florida Recruiting
AdventHealth Orlando Orlando Florida Recruiting
HCA Florida Northside Hospital Petersburg Florida Recruiting
Tampa General Hospital Tampa Florida Recruiting
St. Joseph Hospital - BayCare Tampa Florida Recruiting
University Hospital Augusta Augusta Georgia Recruiting
Memorial Hospital Belleville Belleville Illinois Recruiting
Glenbrook Hospital Glenview Illinois Recruiting
Loyola University Medical Center Maywood Illinois Recruiting
KUMC Kansas City Kansas Completed
LSU Health Sciences Center Shreveport Louisiana Recruiting
Massachusetts General Hospital Boston Massachusetts Recruiting
Charlton Memorial Hospital Fall River Massachusetts Recruiting
Ascension St. John Hospital Detroit Michigan Recruiting
University of Minnesota Minneapolis Minnesota Completed
University of Mississippi Medical Center Jackson Mississippi Recruiting
Mercy Hospital South St Louis Missouri Recruiting
Cooper Health System Camden New Jersey Recruiting
Lovelace Health System Albuquerque New Mexico Recruiting
Bellevue Hospital Center New York New York Recruiting
Mount Sinai Hospital New York New York Recruiting
Columbia University Medical Center/NYPH New York New York Recruiting
St. Francis Hospital and Heart Center Roslyn New York Recruiting
Staten Island University Hospital Staten Island New York Recruiting
SUNY Upstate Medical University Syracuse New York Recruiting
NC Heart and Vascular Research Raleigh North Carolina Recruiting

+ 39 more sites — see the full list on the official registry below.

More Penumbra Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04798261 on ClinicalTrials.gov ↗ ← All trials in the USA