Endovascular Engineering ENGULF Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

181 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-12

Study Completion Date

2025-09-30

Brief Summary

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

Detailed Description

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Conditions

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Pulmonary Embolism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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 131 subjects, to yield 100 evaluable subjects at 48 hours post procedure.

Group Type EXPERIMENTAL

Hēlo PE Thombectomy System

Intervention Type DEVICE

Treatment with the Hēlo PE Thombectomy System for thromboembolectomy

Interventions

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Hēlo PE Thombectomy System

Treatment with the Hēlo PE Thombectomy System for thromboembolectomy

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrew Klein, MD

Role: PRINCIPAL_INVESTIGATOR

Piedmont Heart

Julie Bulman, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

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United States

Central Contacts

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Patricia Chu

Role: CONTACT

Phone: 3103089089

Role: primary

Mallory Yarolimek

Role: backup

Other Identifiers

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CLN01001

Identifier Type: -

Identifier Source: org_study_id

Endovascular Engineering ENGULF Study

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

Investigational Device

Hēlo PE Thombectomy System

Interventions

Hēlo PE Thombectomy System

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors