Endovascular Engineering ENGULF Study (ENGULF)

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

Evaluation of initial safety and clinical feasibility of the Hēlo PE Thrombectomy System for thrombectomy in acute submassive pulmonary embolism (PE).

Study Overview

• Status: Completed
• Conditions: Pulmonary Embolism
• Intervention / Treatment: Device: Hēlo PE Thombectomy System

• Study Type: Interventional
• Enrollment (Actual): 177
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90017
      • PIH Health Good Samaritan Hospital
    • Pasadena, California, United States, 91105
      • Huntington Hospital
    • Torrance, California, United States, 90505
      • Torrance Memorial Medical Center
    • Torrance, California, United States, 90502
      • The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
  • Florida
    • Delray Beach, Florida, United States, 33484
      • Delray Medical Center
    • Jacksonville, Florida, United States, 32207
      • Baptist Health Research Institute
    • Jacksonville, Florida, United States, 32216
      • HCA Florida Memorial Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Northside Hospital
    • Atlanta, Georgia, United States, 30309
      • Piedmont Heart
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02215
      • Brigham and Women's Hospital
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • TriHealth Hatton Research Institute
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19122
      • Temple University
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Wellmont Cardiology Services / Ballad Health
    • Knoxville, Tennessee, United States, 37934
      • Tennova Healthcare - Turkey Creek Medical Center
  • Texas
    • Austin, Texas, United States, 78705
      • Austin Heart
    • Dallas, Texas, United States, 75204
      • Baylor Scott & White Research Institute
    • Houston, Texas, United States, 77030
      • UT Health
  • Wisconsin
    • La Crosse, Wisconsin, United States, 54601
      • Gundersen Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Investigational Device; The study design includes two cohorts: a Pre-Pivotal Cohort of up to 50 subjects (25 Feasibility and up to 25 Roll-Ins), and a Pivotal Cohort enrolling up to 170 subjects, to yield 100 evaluable subjects at 48 hours post procedure treated with the Helo PE Thrombectomy System and no less than 40 subjects treated with blood reinfusion via the Helo BRS.	Device: Hēlo PE Thombectomy System; Treatment with the Hēlo PE Thombectomy System for thromboembolectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Safety Objective	Composite device-related Major Adverse Event (MAE) rate, defined as any of the following events within 48 hours (+/- 24 hours) of the procedure: Death; Life-threatening, disabling or major bleeding as defined by VARC-2; Serious adverse events, including, clinical deterioration, pulmonary vascular injury, and cardiac injury	48 hours following the procedure
Primary Performance Objective	Clinical Success, defined as the reduction in RV/LV ratio from baseline to 48 hours (+/- 24 hours, or discharge, whichever occurs first) as assessed by CTA	48 hours following the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Performance Objective	Clinical Success, defined as the reduction in RV/LV ratio from baseline to 48 hours (+/- 24 hours, or discharge, whichever occurs first) as assessed by CTA	48 hours following the procedure

Collaborators and Investigators

• Sponsor: Endovascular Engineering
• Investigators: Principal Investigator: Andrew Klein, MD, Piedmont Heart; Principal Investigator: Julie Bulman, MD, Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2023
• Primary Completion (Actual): March 2, 2026
• Study Completion (Actual): March 30, 2026

Study Registration Dates

• First Submitted: October 14, 2022
• First Submitted That Met QC Criteria: October 24, 2022
• First Posted (Actual): October 28, 2022

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Pulmonary Embolism
• Other Study ID Numbers: CLN01001

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