RECRUITING

Endovascular Engineering ENGULF Study

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2023-01-12

Study Completion:2025-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05597891

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 90 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
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	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

Inclusion Criteria

Exclusion Criteria

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

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

Contacts and Locations

Study Contact

Patricia Chu

CONTACT

3103089089

pchu@endovascularengineering.com

Debra Cogan

CONTACT

4085150820

dcogan@endovascularengineering.com

Principal Investigator

Andrew Klein, MD

PRINCIPAL_INVESTIGATOR

Piedmont Heart

Julie Bulman, MD

PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Study Locations (Sites)

The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Torrance, California, 90502

United States

Torrance Memorial Medical Center

Torrance, California, 90505

United States

Delray Medical Center

Delray Beach, Florida, 33484

United States

HCA Florida Memorial Hospital

Jacksonville, Florida, 32216

United States

Piedmont Heart

Atlanta, Georgia, 30309

United States

Northside Hospital

Atlanta, Georgia, 30342

United States

Indiana University

Indianapolis, Indiana, 46202

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

United States

Brigham and Women's Hospital

Boston, Massachusetts, 02215

United States

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

Wellmont Cardiology Services / Ballad Health

Kingsport, Tennessee, 37660

United States

Tennova Healthcare - Turkey Creek Medical Center

Knoxville, Tennessee, 37934

United States

Austin Heart

Austin, Texas, 78705

United States

Collaborators and Investigators

Sponsor: Endovascular Engineering

Andrew Klein, MD, PRINCIPAL_INVESTIGATOR, Piedmont Heart
Julie Bulman, MD, PRINCIPAL_INVESTIGATOR, Beth Israel Deaconess Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-12

Study Completion Date2025-09-30

Study Record Updates

Study Start Date2023-01-12

Study Completion Date2025-09-30

Terms related to this study

Additional Relevant MeSH Terms

Pulmonary Embolism