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Evaluation of a new thrombectomy system for treating pulmonary embolism

A Safety and Feasibility Single-Arm Study of a Novel Catheter Thrombectomy Device For the Treatment of Pulmonary Embolism (ENGULF)

Not applicable Interventional Endovascular Engineering · NCT05597891

This study is testing a new device to see if it can safely remove blood clots from the lungs in patients with a serious type of pulmonary embolism.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment181 (estimated)
Ages18 Years to 90 Years
SexAll
SponsorEndovascular Engineering Industry-sponsored
Locations19 sites (Pasadena, California and 18 other locations)
Trial IDNCT05597891 on ClinicalTrials.gov

What this trial studies

This study evaluates the initial safety and clinical feasibility of the Hēlo PE Thrombectomy System in patients with acute submassive pulmonary embolism. Participants will undergo a thrombectomy procedure using this innovative device to assess its effectiveness in removing blood clots from the pulmonary arteries. The study aims to gather data on the system's performance and its potential to improve patient outcomes in this critical condition. The trial will include patients who meet specific clinical criteria related to their pulmonary embolism diagnosis.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 90 who exhibit clinical signs of acute submassive pulmonary embolism and meet specific diagnostic criteria.

Not a fit: Patients with chronic pulmonary embolism or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new, effective treatment option for patients suffering from acute submassive pulmonary embolism.

How similar studies have performed: While this approach is innovative, similar studies evaluating thrombectomy systems for pulmonary embolism have shown promising results, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Asterisks \* indicate entry criteria that can be evaluated during prescreening without obtaining informed consent as they are part of standard of care PE management. Asterisks in parenthesis (\*) indicate entry criteria that can be evaluated during prescreening without obtaining informed consent at Sites that routinely perform CTA as part of standard of care in PE management.

Inclusion Criteria:

Patients must meet ALL of the following criteria to be eligible for participation in the study:

1. \*Patient is \> 18 and \< 90 years old
2. \*Clinical signs and symptoms consistent with acute submassive PE with duration ≤ 14 days, as determined by the Investigator
3. (\*)CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery)
4. (\*)RV/LV ratio of ≥ 0.9 (Enrollment qualification assessment based on Investigator's interpretation of RV/LV ratio at baseline)
5. \*Systolic blood pressure ≥ 90 mmHg (initial SBP may be ≥ 80 mmHg if the pressure recovers to ≥ 90 mmHg with fluids)
6. \*Heart rate \< 130 BPM prior to procedure
7. \*Patient is deemed medically eligible for interventional procedure(s), per investigator guidelines and clinical judgment
8. Patient signs a written Informed Consent form to participate in the study, prior to any study mandated procedures

Exclusion Criteria:

Patients must be EXCLUDED from participation in this study if ANY of the following criteria are met:

1. \*Acute massive PE at presentation
2. \*Prior PE within last 6 months
3. \*Thrombolytic use within 30 days of baseline CTA
4. \*Pulmonary hypertension with peak pulmonary artery systolic pressure \> 70 mmHg by right heart catheterization
5. \*Vasopressor requirement after fluids to keep pressure ≥ 90 mmHg
6. \*FiO2 requirement \> 40% or \> 6 LPM to keep oxygen saturation \> 90%
7. \*Hematocrit \< 28% (NOTE: hematocrit required within 24 hours of index procedure)
8. \*Platelets \< 100,000/μL
9. \*Serum creatinine \> 1.8 mg/dL
10. \*International normalized ratio (INR) \> 3
11. \*aPTT (or PTT) \> 50 seconds on no anticoagulation
12. \*Major trauma \< 14 days
13. \*Presence of intracardiac lead in the right ventricle or right atrium placed within 6 months
14. \*Cardiovascular or pulmonary surgery within last 7 days
15. \*Life expectancy less than 1 year due to advanced malignancy, as determined by the investigator at the time of enrollment
16. \*Known bleeding diathesis or coagulation disorder
17. \*Known left bundle branch block
18. \*History of severe pulmonary arterial hypertension
19. \*History of chronic left heart disease with left ventricular ejection fraction ≤ 30%
20. \*History of uncompensated heart failure
21. \*History of underlying lung disease that is oxygen dependent
22. \*Presence of IVC filter and or iliocaval stents
23. \*History of heparin-induced thrombocytopenia (HIT)
24. \*Any contraindication to systemic or therapeutic doses of heparin or anticoagulants
25. \*Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated
26. \*Known allergy to any device component
27. (\*)Imaging evidence or other evidence that suggests, in the opinion of the Investigator, the Subject is not appropriate for mechanical thrombectomy intervention (e.g., inability to navigate to target location, predominately chronic clot or non-clot embolus)
28. \*Life expectancy of \< 90 days, as determined by Investigator
29. \*Female who is pregnant or nursing
30. \*Current participation in another investigational drug or device treatment study

Where this trial is running

Pasadena, California and 18 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Pulmonary Embolism
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.