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NCT04798261Recruiting

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

Penumbra Inc.

Start Date

6/25/2021

Completion Date

2/1/2028

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 Criteria

Age Range: 18 years to No maximum

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

Interventions

DEVICE

Indigo Aspiration System

Interested in This Trial?

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Conditions

Pulmonary Embolism

Locations

Long Beach Medical Center

Long Beach, California 90806

United States

Cedars-Sinai Medical Center

Los Angeles, California 90048

United States

UCLA Medical Center

Los Angeles, California 90095

United States

UC Irvine Medical Center

Orange, California 92868

United States

UCSD Jacobs

San Diego, California 92037

United States

Sharp Memorial Hospital

San Diego, California 92123

United States

Christiana Care Hospital

Newark, Delaware 19718

United States

MedStar Washington Hospital Center

Washington D.C., District of Columbia 20010

United States

Manatee Memorial Hospital

Bradenton, Florida 34205

United States

Blake Medical Center/Nova Clinical Research

Brandenton, Florida 34209

United States

Delray Medical Center, Inc.

Delray Beach, Florida 33484

United States

University of Florida Shands Hospital

Gainesville, Florida 32608

United States

Radiology and Imaging Specialists

Lakeland, Florida 33805

United States

Jackson Memorial Hospital

Miami, Florida 33136

United States

Baptist Health Miami Cardiac and Vascular Institute

Miami, Florida 33176

United States

AdventHealth Orlando

Orlando, Florida 32803

United States

HCA Florida Northside Hospital

Petersburg, Florida 33709

United States

Tampa General Hospital

Tampa, Florida 33606

United States

St. Joseph Hospital - BayCare

Tampa, Florida 33614

United States

University Hospital Augusta

Augusta, Georgia 30901

United States

Memorial Hospital Belleville

Belleville, Illinois 62226

United States

Glenbrook Hospital

Glenview, Illinois 60026

United States

Loyola University Medical Center

Maywood, Illinois 600153

United States

KUMC

Kansas City, Kansas 66160

United States

LSU Health Sciences Center

Shreveport, Louisiana 71103

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Charlton Memorial Hospital

Fall River, Massachusetts 02720

United States

Ascension St. John Hospital

Detroit, Michigan 48236

United States

University of Minnesota

Minneapolis, Minnesota 55455

United States

University of Mississippi Medical Center

Jackson, Mississippi 39216

United States

Mercy Hospital South

St Louis, Missouri 63128

United States

Cooper Health System

Camden, New Jersey 08103

United States

Lovelace Health System

Albuquerque, New Mexico 87102

United States

Bellevue Hospital Center

New York, New York 10016

United States

Mount Sinai Hospital

New York, New York 10029

United States

Columbia University Medical Center/NYPH

New York, New York 10032

United States

St. Francis Hospital and Heart Center

Roslyn, New York 11576

United States

Staten Island University Hospital

Staten Island, New York 10305

United States

SUNY Upstate Medical University

Syracuse, New York 13210

United States

NC Heart and Vascular Research

Raleigh, North Carolina 27607

United States

Christ Hospital

Cincinnati, Ohio 45219

United States

TriHealth Good Samaritan Hospital

Cincinnati, Ohio 45220

United States

Mount Carmel East

Columbus, Ohio 43213

United States

Kettering Medical Center

Kettering, Ohio 45429

United States

ProMedica Toledo Hospital

Toledo, Ohio 43606

United States

INTEGRIS Baptist Medical Center

Oklahoma City, Oklahoma 73112

United States

Hillcrest Medical Center

Tulsa, Oklahoma 74104

United States

UPMC Harrisburg

Harrisburg, Pennsylvania 17101

United States

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania 17033

United States

Temple University Hospital

Philadelphia, Pennsylvania 19140

United States

Miriam Hospital

Providence, Rhode Island 02903

United States

Jackson-Madison County General Hospital

Jackson, Tennessee 38301

United States

Turkey Creek Medical Center

Knoxville, Tennessee 37934

United States

Methodist Hospital Metropolitan

San Antonio, Texas 78112

United States

Houston Methodist The Woodlands Hospital

The Woodlands, Texas 77385

United States

Christus Mother Frances Hospital

Tyler, Texas 75701

United States

Sentara Norfolk General

Norfolk, Virginia 23507

United States

Medical College of Wisconsin

Milwaukee, Wisconsin 53226

United States

Westmead Hospital

Westmead, New South Wales 2145

Australia

Flinders Medical Centre

Bedford Park, South Australia 5043

Australia

MedUni Graz-Univ.-Klinikum Graz

Graz, 8036

Austria

Hospital Santa Lucia Sul

Brasília, 70390-700

Brazil

Universitätsmedizin Mannheim

Mannheim, Baden-Wurttemberg 68167

Germany

Universitaetsmedizin Mainz

Mainz, 55131

Germany

GRN-Klinik Weinheim

Weinheim, 69469

Germany

Ospedale Misericordia

Grosseto, 58100

Italy

Ospedale San Giovanni Bosco

Torino, 10154

Italy

Leids Universitair Medisch Centrum

Leiden, 2333 ZA

Netherlands

Krakowski Szpital Specjalistyczny św. Jana Pawła II

Krakow, 31-202

Poland

Europejskie Centrum Zdrowia Otwock

Otwock, 05-400

Poland

Uniwersytecki Szpital Kliniczny w Poznaniu

Poznan, 61-848

Poland

Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego

Warsaw, 02-005

Poland

Hospital de Santa Cruz

Carnaxide, 2790-134

Portugal

Hospital Universitario Virgen de la Nieves

Granada, 18014

Spain

Hospital Clínico Universitario Lozano Blesa

Zaragoza, 50009

Spain

Inselspital, Universitätsspital Bern

Bern, CH-3010

Switzerland

Royal Sussex County Hospital

Brighton, Sussex BN2 5BE

United Kingdom

University Hospital of Wales

Cardiff, Wales CF14 4XW

United Kingdom

Royal Free Hospital

London, NW3 2QG

United Kingdom