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

May 14, 2026 updated by: Penumbra Inc.

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Australia
    • South Australia
      • Bedford Park, South Australia, Australia, 5043
        • Recruiting
        • Flinders Medical Centre
  • Brazil
      • Brasília, Brazil, 70390-700
        • Recruiting
        • Hospital Santa Lucia Sul
  • Germany
      • Mainz, Germany, 55131
        • Recruiting
        • Universitaetsmedizin Mainz
      • Weinheim, Germany, 69469
        • Completed
        • GRN-Klinik Weinheim
    • Baden-Wurttemberg
      • Mannheim, Baden-Wurttemberg, Germany, 68167
        • Recruiting
        • Universitätsmedizin Mannheim
  • Italy
      • Grosseto, Italy, 58100
        • Recruiting
        • Ospedale Misericordia
      • Torino, Italy, 10154
        • Recruiting
        • Ospedale San Giovanni Bosco
  • Netherlands
      • Leiden, Netherlands, 2333 ZA
        • Recruiting
        • Leids Universitair Medisch Centrum
  • Poland
      • Krakow, Poland, 31-202
        • Recruiting
        • Krakowski Szpital Specjalistyczny św. Jana Pawła II
      • Otwock, Poland, 05-400
        • Recruiting
        • Europejskie Centrum Zdrowia Otwock
      • Poznan, Poland, 61-848
        • Recruiting
        • Uniwersytecki Szpital Kliniczny w Poznaniu
      • Warsaw, Poland, 02-005
        • Recruiting
        • Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
  • Portugal
      • Carnaxide, Portugal, 2790-134
        • Recruiting
        • Hospital de Santa Cruz
  • Spain
      • Granada, Spain, 18014
        • Recruiting
        • Hospital Universitario Virgen de la Nieves
      • Zaragoza, Spain, 50009
        • Recruiting
        • Hospital Clínico Universitario Lozano Blesa
  • Switzerland
      • Bern, Switzerland, CH-3010
        • Recruiting
        • Inselspital, Universitätsspital Bern
  • United Kingdom
      • London, United Kingdom, NW3 2QG
        • Recruiting
        • Royal Free Hospital
    • Sussex
      • Brighton, Sussex, United Kingdom, BN2 5BE
        • Recruiting
        • Royal Sussex County Hospital
    • Wales
      • Cardiff, Wales, United Kingdom, CF14 4XW
        • Recruiting
        • University Hospital of Wales
  • United States
    • California
      • Long Beach, California, United States, 90806
        • Recruiting
        • Long Beach Medical Center
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars-Sinai Medical Center
      • Los Angeles, California, United States, 90095
        • Recruiting
        • UCLA Medical Center
      • Orange, California, United States, 92868
        • Recruiting
        • UC Irvine Medical Center
      • San Diego, California, United States, 92123
        • Recruiting
        • Sharp Memorial Hospital
      • San Diego, California, United States, 92037
        • Recruiting
        • UCSD Jacobs
    • Delaware
      • Newark, Delaware, United States, 19718
        • Recruiting
        • Christiana Care Hospital
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Recruiting
        • Medstar Washington Hospital Center
    • Florida
      • Bradenton, Florida, United States, 34205
        • Recruiting
        • Manatee Memorial Hospital
      • Brandenton, Florida, United States, 34209
        • Recruiting
        • Blake Medical Center/Nova Clinical Research
      • Delray Beach, Florida, United States, 33484
        • Recruiting
        • Delray Medical Center, Inc.
      • Gainesville, Florida, United States, 32608
        • Recruiting
        • University of Florida Shands Hospital
      • Lakeland, Florida, United States, 33805
        • Recruiting
        • Radiology and Imaging Specialists
      • Miami, Florida, United States, 33136
        • Recruiting
        • Jackson Memorial Hospital
      • Miami, Florida, United States, 33176
        • Recruiting
        • Baptist Health Miami Cardiac and Vascular Institute
      • Orlando, Florida, United States, 32803
        • Recruiting
        • AdventHealth Orlando
      • Petersburg, Florida, United States, 33709
        • Recruiting
        • HCA Florida Northside Hospital
      • Tampa, Florida, United States, 33606
        • Recruiting
        • Tampa General Hospital
      • Tampa, Florida, United States, 33614
        • Recruiting
        • St. Joseph Hospital - BayCare
    • Georgia
      • Augusta, Georgia, United States, 30901
        • Recruiting
        • University Hospital Augusta
    • Illinois
      • Belleville, Illinois, United States, 62226
        • Recruiting
        • Memorial Hospital Belleville
      • Maywood, Illinois, United States, 600153
        • Recruiting
        • Loyola University Medical Center
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Completed
        • KUMC
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • Recruiting
        • LSU Health Sciences Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
      • Fall River, Massachusetts, United States, 02720
        • Recruiting
        • Charlton Memorial Hospital
    • Michigan
      • Detroit, Michigan, United States, 48236
        • Recruiting
        • Ascension St. John Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Completed
        • University of Minnesota
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Recruiting
        • University of Mississippi Medical Center
    • Missouri
      • St Louis, Missouri, United States, 63128
        • Recruiting
        • Mercy Hospital South
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Recruiting
        • Cooper Health System
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Recruiting
        • Lovelace Health System
    • New York
      • New York, New York, United States, 10029
        • Recruiting
        • Mount Sinai Hospital
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Medical Center/NYPH
      • New York, New York, United States, 10016
        • Recruiting
        • Bellevue Hospital Center
      • Roslyn, New York, United States, 11576
        • Recruiting
        • St. Francis Hospital and Heart Center
      • Staten Island, New York, United States, 10305
        • Recruiting
        • Staten Island University Hospital
      • Syracuse, New York, United States, 13210
        • Recruiting
        • SUNY Upstate Medical University
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • Recruiting
        • NC Heart and Vascular Research
    • Ohio
      • Cincinnati, Ohio, United States, 45220
        • Recruiting
        • TriHealth Good Samaritan Hospital
      • Cincinnati, Ohio, United States, 45219
        • Completed
        • Christ Hospital
      • Columbus, Ohio, United States, 43213
        • Recruiting
        • Mount Carmel East
      • Kettering, Ohio, United States, 45429
        • Recruiting
        • Kettering Medical Center
      • Toledo, Ohio, United States, 43606
        • Recruiting
        • ProMedica Toledo Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Recruiting
        • INTEGRIS Baptist Medical Center
      • Tulsa, Oklahoma, United States, 74104
        • Recruiting
        • Hillcrest Medical Center
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17101
        • Recruiting
        • UPMC Harrisburg
      • Hershey, Pennsylvania, United States, 17033
        • Recruiting
        • Penn State Health Milton S. Hershey Medical Center
      • Philadelphia, Pennsylvania, United States, 19140
        • Recruiting
        • Temple University Hospital
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Recruiting
        • Miriam Hospital
    • Tennessee
      • Jackson, Tennessee, United States, 38301
        • Recruiting
        • Jackson-Madison County General Hospital
      • Knoxville, Tennessee, United States, 37934
        • Recruiting
        • Turkey Creek Medical Center
    • Texas
      • San Antonio, Texas, United States, 78112
        • Recruiting
        • Methodist Hospital Metropolitan
      • The Woodlands, Texas, United States, 77385
        • Recruiting
        • Houston Methodist The Woodlands Hospital
      • Tyler, Texas, United States, 75701
        • Recruiting
        • Christus Mother Frances Hospital
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Recruiting
        • Sentara Norfolk General
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with acute pulmonary embolism

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patients with acute pulmonary embolism
Device: Indigo Aspiration System
Indigo Aspiration System

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
48 hours
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)
48 hours post-procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quality of Life assessed via PEmb-QoL
Time Frame: 90 days post-procedure
Self-assessment of PE related complaints and daily living limitations (including work and social)
90 days post-procedure
Quality of Life assessed via EQ-5D-5L
Time Frame: 90 days post-procedure
Self-assessment of activities of daily living
90 days post-procedure
Functional outcome assessed NYHA
Time Frame: 90 days post-procedure
Physician assessment of heart failure symptoms and activity level
90 days post-procedure
Functional outcome assessed via 6MWT
Time Frame: 90 days post-procedure
Walking distance over a 6 minute period to assess functional capacity
90 days post-procedure
Perceived dyspnea assessed via Borg Scale
Time Frame: 90 days post-procedure
Category rating scale to measure perceived dyspnea
90 days post-procedure
Incidence of device related SAE(s)
Time Frame: 365 days
365 days
Any-cause mortality
Time Frame: Within 30 days
Within 30 days
Symptomatic PE recurrence
Time Frame: Within 30 days
Within 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Penumbra Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: John Moriarty, MD, University of California, Los Angeles
  • Principal Investigator: Aleksander Araszkiewicz, MD, PhD, Uniwersytecki Szpital Kliniczny w Poznaniu

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 25, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 26, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 15, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18135

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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