Early access
Sign in
Taking people in United StatesNo phase

Long-term safety and outcomes of the Indigo Aspiration System for pulmonary embolism

Follows adults with pulmonary embolism treated using the Indigo Aspiration System device.

Key facts

Who runs it
Penumbra Inc.
Where
Albuquerque, Augusta, Belleville, Boston, Bradenton, Brandenton, Camden, Cincinnati, Columbus, Delray Beach, Detroit, Fall River, Gainesville, Glenview, Harrisburg, Hershey, Jackson, Kansas City, Kettering, Knoxville, Lakeland, Long Beach, Los Angeles, Maywood, Miami, Milwaukee, Minneapolis, New York, Newark, Norfolk, Oklahoma City, Orange, Orlando, Petersburg, Philadelphia, Providence, Raleigh, Roslyn, San Antonio, San Diego, Shreveport, St Louis, Staten Island, Syracuse, Tampa, The Woodlands, Toledo, Tulsa, Tyler, and Washington D.C., United StatesSee the 58 sitesAlso in 11 other countries, 21 sites
Trial code
Registry title
Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System
Status
Recruiting
People taking part
1,500 people, planned
Started
25 Jun 2021
Expected to end
Feb 2028
Type of study
Observational
Treatments tested
  • Indigo Aspiration System
Record updated
6 November 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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 take part

  • Stage IV (metastatic) cancer, active lung cancer or previous history of surgery in the affected lung(s) or chest radiation
  • 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
  • Contraindication to systemic or therapeutic doses of anticoagulants (e.g. heparin)
  • Known serious, uncontrolled sensitivity to radiographic agents
  • Life expectancy < 180 days
  • Patients on ECMO
  • Pregnant patients

Where in United States

Also in 11 other countries, 21 sites

  • Lovelace Health SystemAlbuquerque, United StatesContact: Joanne KrasnoffTaking people
  • University Hospital AugustaAugusta, United StatesContact: Joanne KrasnoffTaking people
  • Memorial Hospital BellevilleBelleville, United StatesContact: Joanne KrasnoffTaking people
  • Massachusetts General HospitalBoston, United StatesContact: Joanne KrasnoffTaking people
  • Manatee Memorial HospitalBradenton, United StatesContact: Joanne KrasnoffTaking people
  • Blake Medical Center/Nova Clinical ResearchBrandenton, United StatesContact: Joanne KrasnoffTaking people
  • Cooper Health SystemCamden, United StatesContact: Joanne KrasnoffTaking people
  • TriHealth Good Samaritan HospitalCincinnati, United StatesContact: Joanne KrasnoffTaking people
  • Christ HospitalCincinnati, United StatesContact: Joanne KrasnoffNo longer taking part
  • Mount Carmel EastColumbus, United StatesContact: Joanne KrasnoffTaking people
  • Delray Medical Center, Inc.Delray Beach, United StatesContact: Joanne KrasnoffTaking people
  • Ascension St. John HospitalDetroit, United StatesContact: Joanne KrasnoffTaking people
  • Charlton Memorial HospitalFall River, United StatesContact: Joanne KrasnoffTaking people
  • University of Florida Shands HospitalGainesville, United StatesContact: Joanne KrasnoffTaking people
  • Glenbrook HospitalGlenview, United StatesContact: Joanne KrasnoffTaking people
  • UPMC HarrisburgHarrisburg, United StatesContact: Joanne KrasnoffTaking people
  • Penn State Health Milton S. Hershey Medical CenterHershey, United StatesContact: Joanne KrasnoffTaking people
  • Jackson-Madison County General HospitalJackson, United StatesContact: Joanne KrasnoffTaking people
  • University of Mississippi Medical CenterJackson, United StatesContact: Joanne KrasnoffTaking people
  • KUMCKansas City, United StatesContact: Joanne KrasnoffNo longer taking part
  • Kettering Medical CenterKettering, United StatesContact: Joanne KrasnoffTaking people
  • Turkey Creek Medical CenterKnoxville, United StatesContact: Joanne KrasnoffTaking people
  • Radiology and Imaging SpecialistsLakeland, United StatesContact: Joanne KrasnoffTaking people
  • Long Beach Medical CenterLong Beach, United StatesContact: Joanne KrasnoffTaking people
  • Cedars-Sinai Medical CenterLos Angeles, United StatesContact: Joanne KrasnoffTaking people
  • UCLA Medical CenterLos Angeles, United StatesContact: Joanne KrasnoffTaking people
  • Loyola University Medical CenterMaywood, United StatesContact: Joanne KrasnoffTaking people
  • Baptist Health Miami Cardiac and Vascular InstituteMiami, United StatesContact: Joanne KrasnoffTaking people
  • Jackson Memorial HospitalMiami, United StatesContact: Joanne KrasnoffTaking people
  • Medical College of WisconsinMilwaukee, United StatesContact: Joanne KrasnoffTaking people
  • University of MinnesotaMinneapolis, United StatesContact: Joanne KrasnoffNo longer taking part
  • Bellevue Hospital CenterNew York, United StatesContact: Joanne KrasnoffTaking people
  • Columbia University Medical Center/NYPHNew York, United StatesContact: Joanne KrasnoffTaking people
  • Mount Sinai HospitalNew York, United StatesContact: Joanne KrasnoffTaking people
  • Christiana Care HospitalNewark, United StatesContact: Joanne KrasnoffTaking people
  • Sentara Norfolk GeneralNorfolk, United StatesContact: Joanne KrasnoffTaking people
  • Integris Baptist Medical CenterOklahoma City, United StatesContact: Joanne KrasnoffTaking people
  • UC Irvine Medical CenterOrange, United StatesContact: Joanne KrasnoffTaking people
  • AdventHealth OrlandoOrlando, United StatesContact: Joanne KrasnoffTaking people
  • HCA Florida Northside HospitalPetersburg, United StatesContact: Joanne KrasnoffTaking people
  • Temple University HospitalPhiladelphia, United StatesContact: Joanne KrasnoffTaking people
  • Miriam HospitalProvidence, United StatesContact: Joanne KrasnoffTaking people
  • NC Heart and Vascular ResearchRaleigh, United StatesContact: Joanne KrasnoffTaking people
  • St. Francis Hospital and Heart CenterRoslyn, United StatesContact: Joanne KrasnoffTaking people
  • Methodist Hospital MetropolitanSan Antonio, United StatesContact: Joanne KrasnoffTaking people
  • Sharp Memorial HospitalSan Diego, United StatesContact: Joanne KrasnoffTaking people
  • UCSD JacobsSan Diego, United StatesContact: Joanne KrasnoffTaking people
  • LSU Health Sciences CenterShreveport, United StatesContact: Joanne KrasnoffTaking people
  • Mercy Hospital SouthSt Louis, United StatesContact: Joanne KrasnoffTaking people
  • Staten Island University HospitalStaten Island, United StatesContact: Joanne KrasnoffTaking people
  • SUNY Upstate Medical UniversitySyracuse, United StatesContact: Joanne KrasnoffTaking people
  • St. Joseph Hospital - BayCareTampa, United StatesContact: Joanne KrasnoffTaking people
  • Tampa General HospitalTampa, United StatesContact: Joanne KrasnoffTaking people
  • Houston Methodist The Woodlands HospitalThe Woodlands, United StatesContact: Joanne KrasnoffTaking people
  • ProMedica Toledo HospitalToledo, United StatesContact: Joanne KrasnoffTaking people
  • Hillcrest Medical CenterTulsa, United StatesContact: Joanne KrasnoffTaking people
  • Christus Mother Frances HospitalTyler, United StatesContact: Joanne KrasnoffTaking people
  • MedStar Washington Hospital CenterWashington D.C., United StatesContact: Joanne KrasnoffTaking people

About the trial

What the trial wants to find out

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).

The group in the trial

  • Patients with acute pulmonary embolism

    Treatment: Indigo Aspiration System

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Plain-language title
Long-term safety and outcomes of the Indigo Aspiration System for pulmonary embolismGenerated from the registry record. The registry title is the official one.
Record updated
6 November 2026