Menu
Recruiting NCT04798261

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

— Observational Pulmonary Embolism

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Indigo Aspiration System.
Who it may be relevant to
Registry conditions: Pulmonary Embolism. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, Austria, Brazil, Germany +7
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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).

Interventions

  • Device Indigo Aspiration System
    Indigo Aspiration System

Primary outcome measures

  • Safety: Composite of major adverse events [Time frame: 48 hours]
  • Performance: Change in RV/LV Ratio [Time frame: 48 hours post-procedure]
Secondary outcome measures (8)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 58 centers
  • Long Beach Medical Center — Long Beach
  • Cedars-Sinai Medical Center — Los Angeles
  • UCLA Medical Center — Los Angeles
  • UC Irvine Medical Center — Orange
  • UCSD Jacobs — San Diego
  • Sharp Memorial Hospital — San Diego
  • Christiana Care Hospital — Newark
  • MedStar Washington Hospital Center — Washington D.C.
  • … and 50 more centers
Poland · 4 centers
  • Krakowski Szpital Specjalistyczny św. Jana Pawła II — Krakow
  • Europejskie Centrum Zdrowia Otwock — Otwock
  • Uniwersytecki Szpital Kliniczny w Poznaniu — Poznan
  • Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego — Warsaw
Germany · 3 centers
  • Universitätsmedizin Mannheim — Mannheim
  • Universitaetsmedizin Mainz — Mainz
  • GRN-Klinik Weinheim — Weinheim
United Kingdom · 3 centers
  • Royal Sussex County Hospital — Brighton
  • University Hospital of Wales — Cardiff
  • Royal Free Hospital — London
Australia · 2 centers
  • Westmead Hospital — Westmead
  • Flinders Medical Centre — Bedford Park
Italy · 2 centers
  • Ospedale Misericordia — Grosseto
  • Ospedale San Giovanni Bosco — Torino
Spain · 2 centers
  • Hospital Universitario Virgen de la Nieves — Granada
  • Hospital Clínico Universitario Lozano Blesa — Zaragoza
Austria · 1 center
  • MedUni Graz-Univ.-Klinikum Graz — Graz
Brazil · 1 center
  • Hospital Santa Lucia Sul — Brasília
Netherlands · 1 center
  • Leids Universitair Medisch Centrum — Leiden
Portugal · 1 center
  • Hospital de Santa Cruz — Carnaxide
Switzerland · 1 center
  • Inselspital, Universitätsspital Bern — Bern

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 PMID 40878986

Identifiers

NCT: NCT04798261 · 18135

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗