Actively Recruiting
Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System
Led by Penumbra Inc. · Updated on 2026-04-14
1500
Participants Needed
74
Research Sites
344 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical signs and symptoms consistent with acute PE with duration of 14 days or less
- RV/LV ratio 20.9 assessed by diagnostic computed tomographic angiography (CTA) or echocardiogram
- Frontline endovascular treatment with the Indigo Aspiration System per IFU
- Patient is 218 years of age
- Informed consent obtained per Institutional Review Board/Ethics Committee requirements
You will not qualify if you...
- 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 less than 180 days
- Patients on ECMO
- Pregnant patients
- Current participation in another investigational drug or device study that may confound the results of this study
- Other medical, social, or psychological conditions that could limit participation or impact study integrity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 74 locations
1
Long Beach Medical Center
Long Beach, California, United States, 90806
Actively Recruiting
2
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
3
UCLA Medical Center
Los Angeles, California, United States, 90095
Actively Recruiting
4
UC Irvine Medical Center
Orange, California, United States, 92868
Actively Recruiting
5
UCSD Jacobs
San Diego, California, United States, 92037
Actively Recruiting
6
Sharp Memorial Hospital
San Diego, California, United States, 92123
Actively Recruiting
7
Christiana Care Hospital
Newark, Delaware, United States, 19718
Actively Recruiting
8
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
9
Manatee Memorial Hospital
Bradenton, Florida, United States, 34205
Actively Recruiting
10
Blake Medical Center/Nova Clinical Research
Brandenton, Florida, United States, 34209
Actively Recruiting
11
Delray Medical Center, Inc.
Delray Beach, Florida, United States, 33484
Actively Recruiting
12
University of Florida Shands Hospital
Gainesville, Florida, United States, 32608
Actively Recruiting
13
Radiology and Imaging Specialists
Lakeland, Florida, United States, 33805
Actively Recruiting
14
Jackson Memorial Hospital
Miami, Florida, United States, 33136
Actively Recruiting
15
Baptist Health Miami Cardiac and Vascular Institute
Miami, Florida, United States, 33176
Actively Recruiting
16
AdventHealth Orlando
Orlando, Florida, United States, 32803
Actively Recruiting
17
HCA Florida Northside Hospital
Petersburg, Florida, United States, 33709
Actively Recruiting
18
Tampa General Hospital
Tampa, Florida, United States, 33606
Actively Recruiting
19
St. Joseph Hospital - BayCare
Tampa, Florida, United States, 33614
Actively Recruiting
20
University Hospital Augusta
Augusta, Georgia, United States, 30901
Actively Recruiting
21
Memorial Hospital Belleville
Belleville, Illinois, United States, 62226
Actively Recruiting
22
Loyola University Medical Center
Maywood, Illinois, United States, 600153
Actively Recruiting
23
KUMC
Kansas City, Kansas, United States, 66160
Completed
24
LSU Health Sciences Center
Shreveport, Louisiana, United States, 71103
Actively Recruiting
25
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
26
Charlton Memorial Hospital
Fall River, Massachusetts, United States, 02720
Actively Recruiting
27
Ascension St. John Hospital
Detroit, Michigan, United States, 48236
Actively Recruiting
28
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Completed
29
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Actively Recruiting
30
Mercy Hospital South
St Louis, Missouri, United States, 63128
Actively Recruiting
31
Cooper Health System
Camden, New Jersey, United States, 08103
Actively Recruiting
32
Lovelace Health System
Albuquerque, New Mexico, United States, 87102
Actively Recruiting
33
Bellevue Hospital Center
New York, New York, United States, 10016
Actively Recruiting
34
Mount Sinai Hospital
New York, New York, United States, 10029
Actively Recruiting
35
Columbia University Medical Center/NYPH
New York, New York, United States, 10032
Actively Recruiting
36
St. Francis Hospital and Heart Center
Roslyn, New York, United States, 11576
Actively Recruiting
37
Staten Island University Hospital
Staten Island, New York, United States, 10305
Actively Recruiting
38
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
Actively Recruiting
39
NC Heart and Vascular Research
Raleigh, North Carolina, United States, 27607
Actively Recruiting
40
Christ Hospital
Cincinnati, Ohio, United States, 45219
Completed
41
TriHealth Good Samaritan Hospital
Cincinnati, Ohio, United States, 45220
Actively Recruiting
42
Mount Carmel East
Columbus, Ohio, United States, 43213
Actively Recruiting
43
Kettering Medical Center
Kettering, Ohio, United States, 45429
Actively Recruiting
44
ProMedica Toledo Hospital
Toledo, Ohio, United States, 43606
Actively Recruiting
45
INTEGRIS Baptist Medical Center
Oklahoma City, Oklahoma, United States, 73112
Actively Recruiting
46
Hillcrest Medical Center
Tulsa, Oklahoma, United States, 74104
Actively Recruiting
47
UPMC Harrisburg
Harrisburg, Pennsylvania, United States, 17101
Actively Recruiting
48
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Actively Recruiting
49
Miriam Hospital
Providence, Rhode Island, United States, 02903
Actively Recruiting
50
Jackson-Madison County General Hospital
Jackson, Tennessee, United States, 38301
Actively Recruiting
51
Turkey Creek Medical Center
Knoxville, Tennessee, United States, 37934
Actively Recruiting
52
Methodist Hospital Metropolitan
San Antonio, Texas, United States, 78112
Actively Recruiting
53
Houston Methodist The Woodlands Hospital
The Woodlands, Texas, United States, 77385
Actively Recruiting
54
Christus Mother Frances Hospital
Tyler, Texas, United States, 75701
Actively Recruiting
55
Sentara Norfolk General
Norfolk, Virginia, United States, 23507
Actively Recruiting
56
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
57
Flinders Medical Centre
Bedford Park, South Australia, Australia, 5043
Actively Recruiting
58
Hospital Santa Lucia Sul
Brasília, Brazil, 70390-700
Actively Recruiting
59
Universitätsmedizin Mannheim
Mannheim, Baden-Wurttemberg, Germany, 68167
Actively Recruiting
60
GRN-Klinik Weinheim
Weinheim, Germany, 69469
Completed
61
Ospedale Misericordia
Grosseto, Italy, 58100
Actively Recruiting
62
Ospedale San Giovanni Bosco
Torino, Italy, 10154
Actively Recruiting
63
Leids Universitair Medisch Centrum
Leiden, Netherlands, 2333 ZA
Actively Recruiting
64
Krakowski Szpital Specjalistyczny św. Jana Pawła II
Krakow, Poland, 31-202
Actively Recruiting
65
Europejskie Centrum Zdrowia Otwock
Otwock, Poland, 05-400
Actively Recruiting
66
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, Poland, 61-848
Actively Recruiting
67
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Warsaw, Poland, 02-005
Actively Recruiting
68
Hospital de Santa Cruz
Carnaxide, Portugal, 2790-134
Actively Recruiting
69
Hospital Universitario Virgen de la Nieves
Granada, Spain, 18014
Actively Recruiting
70
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Spain, 50009
Actively Recruiting
71
Inselspital, Universitätsspital Bern
Bern, Switzerland, CH-3010
Actively Recruiting
72
Royal Sussex County Hospital
Brighton, Sussex, United Kingdom, BN2 5BE
Actively Recruiting
73
University Hospital of Wales
Cardiff, Wales, United Kingdom, CF14 4XW
Actively Recruiting
74
Royal Free Hospital
London, United Kingdom, NW3 2QG
Actively Recruiting
Research Team
J
Joanne Krasnoff
CONTACT
A
Aisha Pascua
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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