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

Purpose

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).

Condition

  • Pulmonary Embolism

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Patients with acute pulmonary embolism
  • Device: Indigo Aspiration System
    Indigo Aspiration System

Recruiting Locations

Long Beach Medical Center
Long Beach, California 90806

Cedars-Sinai Medical Center
Los Angeles, California 90048

UCLA Medical Center
Los Angeles, California 90095

UC Irvine Medical Center
Orange, California 92868

UCSD Jacobs
San Diego, California 92037

Sharp Memorial Hospital
San Diego, California 92123

Christiana Care Hospital
Newark, Delaware 19718

MedStar Washington Hospital Center
Washington D.C., District of Columbia 20010

Manatee Memorial Hospital
Bradenton, Florida 34205

Blake Medical Center/Nova Clinical Research
Brandenton, Florida 34209

Delray Medical Center, Inc.
Delray Beach, Florida 33484

University of Florida Shands Hospital
Gainesville, Florida 32608

Radiology and Imaging Specialists
Lakeland, Florida 33805

Jackson Memorial Hospital
Miami, Florida 33136

Baptist Health Miami Cardiac and Vascular Institute
Miami, Florida 33176

AdventHealth Orlando
Orlando, Florida 32803

HCA Florida Northside Hospital
Petersburg, Florida 33709

Tampa General Hospital
Tampa, Florida 33606

St. Joseph Hospital - BayCare
Tampa, Florida 33614

University Hospital Augusta
Augusta, Georgia 30901

Memorial Hospital Belleville
Belleville, Illinois 62226

Glenbrook Hospital
Glenview, Illinois 60026

Loyola University Medical Center
Maywood, Illinois 600153

LSU Health Sciences Center
Shreveport, Louisiana 71103

Massachusetts General Hospital
Boston, Massachusetts 02114

Charlton Memorial Hospital
Fall River, Massachusetts 02720

Ascension St. John Hospital
Detroit, Michigan 48236

University of Mississippi Medical Center
Jackson, Mississippi 39216

Mercy Hospital South
St Louis, Missouri 63128

Cooper Health System
Camden, New Jersey 08103

Lovelace Health System
Albuquerque, New Mexico 87102

Bellevue Hospital Center
New York, New York 10016

Mount Sinai Hospital
New York, New York 10029

Columbia University Medical Center/NYPH
New York, New York 10032

St. Francis Hospital and Heart Center
Roslyn, New York 11576

Staten Island University Hospital
Staten Island, New York 10305

SUNY Upstate Medical University
Syracuse, New York 13210

NC Heart and Vascular Research
Raleigh, North Carolina 27607

TriHealth Good Samaritan Hospital
Cincinnati, Ohio 45220

Mount Carmel East
Columbus, Ohio 43213

Kettering Medical Center
Kettering, Ohio 45429

ProMedica Toledo Hospital
Toledo, Ohio 43606

INTEGRIS Baptist Medical Center
Oklahoma City, Oklahoma 73112

Hillcrest Medical Center
Tulsa, Oklahoma 74104

UPMC Harrisburg
Harrisburg, Pennsylvania 17101

Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania 17033

Temple University Hospital
Philadelphia, Pennsylvania 19140

Miriam Hospital
Providence, Rhode Island 02903

Jackson-Madison County General Hospital
Jackson, Tennessee 38301

Turkey Creek Medical Center
Knoxville, Tennessee 37934

Methodist Hospital Metropolitan
San Antonio, Texas 78112

Houston Methodist The Woodlands Hospital
The Woodlands, Texas 77385

Christus Mother Frances Hospital
Tyler, Texas 75701

Sentara Norfolk General
Norfolk, Virginia 23507

Medical College of Wisconsin
Milwaukee, Wisconsin 53226

More Details

Status
Recruiting
Sponsor
Penumbra Inc.

Study Contact

Joanne Krasnoff
650-455-4462
jkrasnoff@penumbrainc.com