Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System
STRIKE-PE: A Prospective, Multicenter Study of the Indigo™ Aspiration System Seeking to Evaluate the Long-Term Safety and Outcomes of Treating Pulmonary Embolism
1 other identifier
observational
1,500
11 countries
74
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2021
Longer than P75 for all trials
74 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2021
CompletedFirst Posted
Study publicly available on registry
March 15, 2021
CompletedStudy Start
First participant enrolled
June 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2028
April 14, 2026
February 1, 2026
5.4 years
February 26, 2021
April 9, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Safety: Composite of major adverse events
A composite of device-related death, major bleeding, device-related clinical deterioration, device-related pulmonary vascular injury and device-related cardiac injury
48 hours
Performance: Change in RV/LV Ratio
Change in RV/LV Ratio (matched imaging pairs CTA or echocardiogram, as available)
48 hours post-procedure
Secondary Outcomes (8)
Quality of Life assessed via PEmb-QoL
90 days post-procedure
Quality of Life assessed via EQ-5D-5L
90 days post-procedure
Functional outcome assessed NYHA
90 days post-procedure
Functional outcome assessed via 6MWT
90 days post-procedure
Perceived dyspnea assessed via Borg Scale
90 days post-procedure
- +3 more secondary outcomes
Study Arms (1)
Patients with acute pulmonary embolism
Interventions
Eligibility Criteria
Patients with acute pulmonary embolism
You may qualify if:
- Clinical signs and symptoms consistent with acute PE with duration of 14 days or less
- RV/LV ratio ≥ 0.9 assessed by diagnostic computed tomographic angiography (CTA) or echocardiogram
- Frontline endovascular treatment with the Indigo Aspiration System per IFU
- Patient is ≥ 18 years of age
- Informed consent obtained per Institutional Review Board/Ethics Committee requirements
You may not qualify if:
- 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 \< 180 days
- Patients on ECMO
- Pregnant patients
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Penumbra Inc.lead
Study Sites (74)
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
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
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
Flinders Medical Centre
Bedford Park, South Australia, 5043, Australia
Hospital Santa Lucia Sul
Brasília, 70390-700, Brazil
Universitätsmedizin Mannheim
Mannheim, Baden-Wurttemberg, 68167, 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
Related Publications (1)
Moriarty JM, Schiro BJ, Dohad SY, Tamaddon H, Davis HC, Shavelle DM, Chrysant GS, Iliadis EA, Dexter DJ 2nd, Ciampi Dopazo JJ, Holden A, West FM, Keeling B, Sharp ASP, Weinberg I. Periprocedural Results and Right Ventricular Outcomes of Computer Assisted Vacuum Thrombectomy Treatment of Acute Pulmonary Embolism: Interim Analysis of 300 Patients From the STRIKE-PE Study. J Am Heart Assoc. 2025 Sep 2;14(17):e039975. doi: 10.1161/JAHA.124.039975. Epub 2025 Aug 29.
PMID: 40878986DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John Moriarty, MD
University of California, Los Angeles
- PRINCIPAL INVESTIGATOR
Aleksander Araszkiewicz, MD, PhD
Uniwersytecki Szpital Kliniczny w Poznaniu
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2021
First Posted
March 15, 2021
Study Start
June 25, 2021
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
February 1, 2028
Last Updated
April 14, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share