Clinical trial NCT05597891: Endovascular Engineering ENGULF Study
Official title: A Safety and Feasibility Single-Arm Study of a Novel Catheter Thrombectomy Device For the Treatment of Pulmonary Embolism (ENGULF)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Embolism
Lead sponsor: Endovascular Engineering
Sponsor class: INDUSTRY
First posted: 2022-10-28
Enrollment: 181
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Primary Safety Objective
timeFrame: 48 hours following the procedure
measure: Primary Performance Objective
timeFrame: 48 hours following the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Huntington Hospital
state: California
city: Torrance
country: United States
facility: The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
state: California
city: Torrance
country: United States
facility: Torrance Memorial Medical Center
state: California
city: Delray Beach
country: United States
facility: Delray Medical Center
state: Florida
city: Jacksonville
country: United States
facility: Baptist Health Research Institute
state: Florida
city: Jacksonville
country: United States
facility: HCA Florida Memorial Hospital
state: Florida
city: Atlanta
country: United States
facility: Piedmont Heart
state: Georgia
city: Atlanta
country: United States
facility: Northside Hospital
state: Georgia
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Cincinnati
country: United States
facility: TriHealth Hatton Research Institute
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Kingsport
country: United States
facility: Wellmont Cardiology Services / Ballad Health
state: Tennessee
city: Knoxville
country: United States
facility: Tennova Healthcare - Turkey Creek Medical Center
state: Tennessee
city: Austin
country: United States
facility: Austin Heart
state: Texas
city: Dallas
country: United States
facility: Baylor Scott & White Research Institute
state: Texas
city: Houston
country: United States
facility: UT Health
state: Texas
city: La Crosse
country: United States
facility: Gundersen Health
state: Wisconsin
Study officials:
affiliation: Piedmont Heart
name: Andrew Klein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beth Israel Deaconess Medical Center
name: Julie Bulman, MD
role: PRINCIPAL_INVESTIGATOR
References: