Recruiting

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

Sponsor:

Penumbra Inc.

Code:

NCT04798261

Conditions

Pulmonary Embolism

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Indigo Aspiration System

Study Details

Brief 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).

Conditions

Pulmonary Embolism

Study ID

NCT04798261

Start date

Jun 25, 2021

Status verified date

Jul, 2026

Completion date

Feb, 2028

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

1500 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients with acute pulmonary embolism

Interventions

Indigo Aspiration System

Primary outcome measure

Safety: Composite of major adverse events [ Time Frame: 48 hours ]
Performance: Change in RV/LV Ratio [ Time Frame: 48 hours post-procedure ]

Central Contacts and Locations

Central contacts

Joanne Krasnoff

650-455-4462 jkrasnoff@penumbrainc.com

Aisha Pascua

415-601-9561 apascua@penumbrainc.com

Locations

Long Beach Medical Center

Recruiting

Long Beach, California, United States, 90806

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

UCLA Medical Center

Recruiting

Los Angeles, California, United States, 90095

UC Irvine Medical Center

Recruiting

Orange, California, United States, 92868

UCSD Jacobs

Recruiting

San Diego, California, United States, 92037

Sharp Memorial Hospital

Recruiting

San Diego, California, United States, 92123

Christiana Care Hospital

Recruiting

Newark, Delaware, United States, 19718

MedStar Washington Hospital Center

Recruiting

Washington D.C., District of Columbia, United States, 20010

Manatee Memorial Hospital

Recruiting

Bradenton, Florida, United States, 34205

Blake Medical Center/Nova Clinical Research

Recruiting

Brandenton, Florida, United States, 34209

Delray Medical Center, Inc.

Recruiting

Delray Beach, Florida, United States, 33484

University of Florida Shands Hospital

Recruiting

Gainesville, Florida, United States, 32608

Radiology and Imaging Specialists

Recruiting

Lakeland, Florida, United States, 33805

Jackson Memorial Hospital

Recruiting

Miami, Florida, United States, 33136

Baptist Health Miami Cardiac and Vascular Institute

Recruiting

Miami, Florida, United States, 33176

AdventHealth Orlando

Recruiting

Orlando, Florida, United States, 32803

HCA Florida Northside Hospital

Recruiting

Petersburg, Florida, United States, 33709

Tampa General Hospital

Recruiting

Tampa, Florida, United States, 33606

St. Joseph Hospital - BayCare

Recruiting

Tampa, Florida, United States, 33614

University Hospital Augusta

Recruiting

Augusta, Georgia, United States, 30901

Memorial Hospital Belleville

Recruiting

Belleville, Illinois, United States, 62226

Glenbrook Hospital

Recruiting

Glenview, Illinois, United States, 60026

Loyola University Medical Center

Recruiting

Maywood, Illinois, United States, 600153

LSU Health Sciences Center

Recruiting

Shreveport, Louisiana, United States, 71103

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Charlton Memorial Hospital

Recruiting

Fall River, Massachusetts, United States, 02720

Ascension St. John Hospital

Recruiting

Detroit, Michigan, United States, 48236

University of Mississippi Medical Center

Recruiting

Jackson, Mississippi, United States, 39216

Mercy Hospital South

Recruiting

St Louis, Missouri, United States, 63128

Cooper Health System

Recruiting

Camden, New Jersey, United States, 08103

Lovelace Health System

Recruiting

Albuquerque, New Mexico, United States, 87102

Bellevue Hospital Center

Recruiting

New York, New York, United States, 10016

Mount Sinai Hospital

Recruiting

New York, New York, United States, 10029

Columbia University Medical Center/NYPH

Recruiting

New York, New York, United States, 10032

St. Francis Hospital and Heart Center

Recruiting

Roslyn, New York, United States, 11576

Staten Island University Hospital

Recruiting

Staten Island, New York, United States, 10305

SUNY Upstate Medical University

Recruiting

Syracuse, New York, United States, 13210

NC Heart and Vascular Research

Recruiting

Raleigh, North Carolina, United States, 27607

TriHealth Good Samaritan Hospital

Recruiting

Cincinnati, Ohio, United States, 45220

Mount Carmel East

Recruiting

Columbus, Ohio, United States, 43213

Kettering Medical Center

Recruiting

Kettering, Ohio, United States, 45429

ProMedica Toledo Hospital

Recruiting

Toledo, Ohio, United States, 43606

INTEGRIS Baptist Medical Center

Recruiting

Oklahoma City, Oklahoma, United States, 73112

Hillcrest Medical Center

Recruiting

Tulsa, Oklahoma, United States, 74104

UPMC Harrisburg

Recruiting

Harrisburg, Pennsylvania, United States, 17101

Penn State Health Milton S. Hershey Medical Center

Recruiting

Hershey, Pennsylvania, United States, 17033

Temple University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19140

Miriam Hospital

Recruiting

Providence, Rhode Island, United States, 02903

Jackson-Madison County General Hospital

Recruiting

Jackson, Tennessee, United States, 38301

Turkey Creek Medical Center

Recruiting

Knoxville, Tennessee, United States, 37934

Methodist Hospital Metropolitan

Recruiting

San Antonio, Texas, United States, 78112

Houston Methodist The Woodlands Hospital

Recruiting

The Woodlands, Texas, United States, 77385

Christus Mother Frances Hospital

Recruiting

Tyler, Texas, United States, 75701

Sentara Norfolk General

Recruiting

Norfolk, Virginia, United States, 23507

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

More Information

Sponsor

Penumbra Inc.

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Penumbra Inc. on 2026-07-06.