Pulmonary EmbolismNCT04798261
Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System
An observational study of Pulmonary Embolism, run by Penumbra Inc. at 79 sites in 12 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- Indigo Aspiration System
- Type of treatment
- Medical device
- How many people
- 1,500 participants
- Where
- 79 sitesin 12 countries
- Study dates
- 25 Jun 2021to Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute pulmonary embolism
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
79 sites in 12 countries. Contact the study team or a site near you to ask about taking part.
79 sites in 12 countries
United States58 sites, 55 recruiting
- Recruiting
Lovelace Health System
Albuquerque, New Mexico, 87102
- Recruiting
University Hospital Augusta
Augusta, Georgia, 30901
- Recruiting
Memorial Hospital Belleville
Belleville, Illinois, 62226
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
- Recruiting
Manatee Memorial Hospital
Bradenton, Florida, 34205
- Recruiting
Blake Medical Center/Nova Clinical Research
Brandenton, Florida, 34209
- Recruiting
Cooper Health System
Camden, New Jersey, 08103
- Completed
Christ Hospital
Cincinnati, Ohio, 45219
- Recruiting
TriHealth Good Samaritan Hospital
Cincinnati, Ohio, 45220
- Recruiting
Mount Carmel East
Columbus, Ohio, 43213
- Recruiting
Delray Medical Center, Inc.
Delray Beach, Florida, 33484
- Recruiting
Ascension St. John Hospital
Detroit, Michigan, 48236
- Recruiting
Charlton Memorial Hospital
Fall River, Massachusetts, 02720
- Recruiting
University of Florida Shands Hospital
Gainesville, Florida, 32608
- Recruiting
Glenbrook Hospital
Glenview, Illinois, 60026
- Recruiting
UPMC Harrisburg
Harrisburg, Pennsylvania, 17101
- Recruiting
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
- Recruiting
University of Mississippi Medical Center
Jackson, Mississippi, 39216
- Recruiting
Jackson-Madison County General Hospital
Jackson, Tennessee, 38301
- Completed
KUMC
Kansas City, Kansas, 66160
- Recruiting
Kettering Medical Center
Kettering, Ohio, 45429
- Recruiting
Turkey Creek Medical Center
Knoxville, Tennessee, 37934
- Recruiting
Radiology and Imaging Specialists
Lakeland, Florida, 33805
- Recruiting
Long Beach Medical Center
Long Beach, California, 90806
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
- Recruiting
UCLA Medical Center
Los Angeles, California, 90095
- Recruiting
Loyola University Medical Center
Maywood, Illinois, 600153
- Recruiting
Jackson Memorial Hospital
Miami, Florida, 33136
- Recruiting
Baptist Health Miami Cardiac and Vascular Institute
Miami, Florida, 33176
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
- Completed
University of Minnesota
Minneapolis, Minnesota, 55455
- Recruiting
Bellevue Hospital Center
New York, New York, 10016
- Recruiting
Mount Sinai Hospital
New York, New York, 10029
- Recruiting
Columbia University Medical Center/NYPH
New York, New York, 10032
- Recruiting
Christiana Care Hospital
Newark, Delaware, 19718
- Recruiting
Sentara Norfolk General
Norfolk, Virginia, 23507
- Recruiting
INTEGRIS Baptist Medical Center
Oklahoma City, Oklahoma, 73112
- Recruiting
UC Irvine Medical Center
Orange, California, 92868
- Recruiting
AdventHealth Orlando
Orlando, Florida, 32803
- Recruiting
HCA Florida Northside Hospital
Petersburg, Florida, 33709
- Recruiting
Temple University Hospital
Philadelphia, Pennsylvania, 19140
- Recruiting
Miriam Hospital
Providence, Rhode Island, 02903
- Recruiting
NC Heart and Vascular Research
Raleigh, North Carolina, 27607
- Recruiting
St. Francis Hospital and Heart Center
Roslyn, New York, 11576
- Recruiting
Methodist Hospital Metropolitan
San Antonio, Texas, 78112
- Recruiting
UCSD Jacobs
San Diego, California, 92037
- Recruiting
Sharp Memorial Hospital
San Diego, California, 92123
- Recruiting
LSU Health Sciences Center
Shreveport, Louisiana, 71103
- Recruiting
Mercy Hospital South
St Louis, Missouri, 63128
- Recruiting
Staten Island University Hospital
Staten Island, New York, 10305
- Recruiting
SUNY Upstate Medical University
Syracuse, New York, 13210
- Recruiting
Tampa General Hospital
Tampa, Florida, 33606
- Recruiting
St. Joseph Hospital - BayCare
Tampa, Florida, 33614
- Recruiting
Houston Methodist The Woodlands Hospital
The Woodlands, Texas, 77385
- Recruiting
ProMedica Toledo Hospital
Toledo, Ohio, 43606
- Recruiting
Hillcrest Medical Center
Tulsa, Oklahoma, 74104
- Recruiting
Christus Mother Frances Hospital
Tyler, Texas, 75701
- Recruiting
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Poland4 sites, 4 recruiting
- Recruiting
Krakowski Szpital Specjalistyczny św. Jana Pawła II
Krakow, 31-202
- Recruiting
Europejskie Centrum Zdrowia Otwock
Otwock, 05-400
- Recruiting
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, 61-848
- Recruiting
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Warsaw, 02-005
Germany3 sites, 2 recruiting
- Recruiting
Universitaetsmedizin Mainz
Mainz, 55131
- Recruiting
Universitätsmedizin Mannheim
Mannheim, Baden-Wurttemberg, 68167
- Completed
GRN-Klinik Weinheim
Weinheim, 69469
United Kingdom3 sites, 2 recruiting
- Recruiting
Royal Sussex County Hospital
Brighton, Sussex, BN2 5BE
- Completed
University Hospital of Wales
Cardiff, Wales, CF14 4XW
- Recruiting
Royal Free Hospital
London, NW3 2QG
Australia2 sites, 2 recruiting
- Recruiting
Flinders Medical Centre
Bedford Park, South Australia, 5043
- Recruiting
Westmead Hospital
Westmead, New South Wales, 2145
Italy2 sites, 2 recruiting
- Recruiting
Ospedale Misericordia
Grosseto, 58100
- Recruiting
Ospedale San Giovanni Bosco
Torino, 10154
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitario Virgen de la Nieves
Granada, 18014
- Recruiting
Hospital Clínico Universitario Lozano Blesa
Zaragoza, 50009
Austria1 site, 1 recruiting
- Recruiting
MedUni Graz-Univ.-Klinikum Graz
Graz, 8036
Brazil1 site, 1 recruiting
- Recruiting
Hospital Santa Lucia Sul
Brasília, 70390-700
Netherlands1 site, 1 recruiting
- Recruiting
Leids Universitair Medisch Centrum
Leiden, 2333 ZA
Portugal1 site, 1 recruiting
- Recruiting
Hospital de Santa Cruz
Carnaxide, 2790-134
Switzerland1 site, 1 recruiting
- Recruiting
Inselspital, Universitätsspital Bern
Bern, CH-3010
About this study
Official title: STRIKE-PE: A Prospective, Multicenter Study of the Indigo™ Aspiration System Seeking to Evaluate the Long-Term Safety and Outcomes of Treating Pulmonary Embolism
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
- Being tested
- Indigo Aspiration System
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indigo Aspiration SystemDevice
Indigo Aspiration System
| Study group | Role | What they receive |
|---|---|---|
| Patients with acute pulmonary embolism | Not described Receives: Device: Indigo Aspiration System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 48 hours
Performance: Change in RV/LV Ratio
Change in RV/LV Ratio (matched imaging pairs CTA or echocardiogram, as available)
Measured: 48 hours post-procedure
Secondary outcomes (8)
Quality of Life assessed via PEmb-QoL
Self-assessment of PE related complaints and daily living limitations (including work and social)
Measured: 90 days post-procedure
Quality of Life assessed via EQ-5D-5L
Self-assessment of activities of daily living
Measured: 90 days post-procedure
Functional outcome assessed NYHA
Physician assessment of heart failure symptoms and activity level
Measured: 90 days post-procedure
Functional outcome assessed via 6MWT
Walking distance over a 6 minute period to assess functional capacity
Measured: 90 days post-procedure
Perceived dyspnea assessed via Borg Scale
Category rating scale to measure perceived dyspnea
Measured: 90 days post-procedure
Incidence of device related SAE(s)
Measured: 365 days
Any-cause mortality
Measured: Within 30 days
Symptomatic PE recurrence
Measured: Within 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start25 Jun 2021
- Primary completionDec 2026 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Penumbra Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Moriarty, MD, Principal investigator, University of California, Los AngelesAleksander Araszkiewicz, MD, PhD, Principal investigator, Uniwersytecki Szpital Kliniczny w Poznaniu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04798261
- Sponsor's protocol ID
- 18135
- Status last verified
- Nov 2026
- First submitted
- 26 Feb 2021
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 40878986
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STRIKE-PE: A Prospective, Multicenter Study of the Indigo™ Aspiration System Seeking to Evaluate the Long-Term Safety and Outcomes of Treating Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT04798261
- Acronym / sponsor ID
- 18135
- Conditions
- Pulmonary Embolism
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Penumbra Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Jun 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 15 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with acute pulmonary embolism | – | Device: Indigo Aspiration System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute pulmonary embolism
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indigo Aspiration SystemIndigo Aspiration System | Device | Patients with acute pulmonary embolism |
Primary outcome
Safety: Composite of major adverse events
Time frame: 48 hours
A composite of device-related death, major bleeding, device-related clinical deterioration, device-related pulmonary vascular injury and device-related cardiac injury
Performance: Change in RV/LV Ratio
Time frame: 48 hours post-procedure
Change in RV/LV Ratio (matched imaging pairs CTA or echocardiogram, as available)
8 secondary outcomes
Quality of Life assessed via PEmb-QoL
Time frame: 90 days post-procedure
Quality of Life assessed via EQ-5D-5L
Time frame: 90 days post-procedure
Functional outcome assessed NYHA
Time frame: 90 days post-procedure
Functional outcome assessed via 6MWT
Time frame: 90 days post-procedure
Perceived dyspnea assessed via Borg Scale
Time frame: 90 days post-procedure
Incidence of device related SAE(s)
Time frame: 365 days
Any-cause mortality
Time frame: Within 30 days
Symptomatic PE recurrence
Time frame: Within 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Derived from this study: PubMed 40878986Moriarty 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.
- Individual participant dataSharing planned: No
Related trials for Pulmonary Embolism
Not yet recruiting
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Pulmonary Embolism (PE), Pulmonary Embolism With Right Ventricle Enlargement
RecruitingObservational study
Inari VISION Registry
Pulmonary Embolism
RecruitingPhase 3
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RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
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REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John Moriarty, MD principal investigator
University of California, Los Angeles
Aleksander Araszkiewicz, MD, PhD principal investigator
Uniwersytecki Szpital Kliniczny w Poznaniu
79 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Embolism, run by Penumbra Inc. at 79 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 79 sites in United States, Poland, Germany, United Kingdom, Australia and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joanne Krasnoff (650-455-4462, jkrasnoff@penumbrainc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: Composite of major adverse events (time frame: 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04798261, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.