Endovascular Engineering ENGULF Study

NCT05597891 | Completed FDA Device

• 1 other identifier: CLN01001
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 21

Brief Summary

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

Conditions

Pulmonary Embolism

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Investigational Device

EXPERIMENTAL

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

Interventions

Hēlo PE Thombectomy System DEVICE

Treatment with the Hēlo PE Thombectomy System for thromboembolectomy

Investigational Device

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients must be EXCLUDED from participation in this study if ANY of the following criteria are met:
• \*Acute massive PE at presentation
• \*Prior PE within last 6 months
• \*Thrombolytic use within 30 days of baseline CTA
• \*Pulmonary hypertension with peak pulmonary artery systolic pressure \> 70 mmHg by right heart catheterization
• \*Vasopressor requirement after fluids to keep pressure ≥ 90 mmHg
• \*FiO2 requirement \> 40% or \> 6 LPM to keep oxygen saturation \> 90%
• \*Hematocrit \< 28% (NOTE: hematocrit required within 24 hours of index procedure)
• \*Platelets \< 100,000/μL
• \*Serum creatinine \> 1.8 mg/dL
• \*International normalized ratio (INR) \> 3
• \*aPTT (or PTT) \> 50 seconds on no anticoagulation
• \*Major trauma \< 14 days
• \*Presence of intracardiac lead in the right ventricle or right atrium placed within 6 months
• \*Cardiovascular or pulmonary surgery within last 7 days

Sponsors & Collaborators

• Endovascular Engineering: lead

Study Sites (21)

PIH Health Good Samaritan Hospital

Los Angeles, California, 90017, United States

Location

Huntington Hospital

Pasadena, California, 91105, United States

Location

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

Torrance, California, 90502, United States

Location

Torrance Memorial Medical Center

Torrance, California, 90505, United States

Location

Delray Medical Center

Delray Beach, Florida, 33484, United States

Location

Baptist Health Research Institute

Jacksonville, Florida, 32207, United States

Location

HCA Florida Memorial Hospital

Jacksonville, Florida, 32216, United States

Location

Piedmont Heart

Atlanta, Georgia, 30309, United States

Location

Northside Hospital

Atlanta, Georgia, 30342, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

Location

TriHealth Hatton Research Institute

Cincinnati, Ohio, 45242, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Temple University

Philadelphia, Pennsylvania, 19122, United States

Location

Wellmont Cardiology Services / Ballad Health

Kingsport, Tennessee, 37660, United States

Location

Tennova Healthcare - Turkey Creek Medical Center

Knoxville, Tennessee, 37934, United States

Location

Austin Heart

Austin, Texas, 78705, United States

Location

Baylor Scott & White Research Institute

Dallas, Texas, 75204, United States

Location

UT Health

Houston, Texas, 77030, United States

Location

Gundersen Health

La Crosse, Wisconsin, 54601, United States

Location

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Andrew Klein, MD

  Piedmont Heart

  PRINCIPAL INVESTIGATOR

• Julie Bulman, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: October 28, 2022
• Study Start: January 12, 2023
• Primary Completion: March 2, 2026
• Study Completion: March 30, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (21)