Pulmonary EmbolismENGULFNCT05597891
Endovascular Engineering ENGULF Study
A study testing Hēlo PE Thombectomy System in people with Pulmonary Embolism, run by Endovascular Engineering at 21 sites in United States.
Trial summary
Evaluation of initial safety and clinical feasibility of the Hēlo PE Thrombectomy System for thrombectomy in acute submassive pulmonary embolism (PE). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- Hēlo PE Thombectomy System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 21 sitesUnited States
- Study dates
- 12 Jan 2023to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- *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
Who cannot join
- 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
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- *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
- *Life expectancy less than 1 year due to advanced malignancy, as determined by the investigator at the time of enrollment
- *Known bleeding diathesis or coagulation disorder
- *Known left bundle branch block
- *History of severe pulmonary arterial hypertension
- *History of chronic left heart disease with left ventricular ejection fraction ≤ 30%
- *History of uncompensated heart failure
- *History of underlying lung disease that is oxygen dependent
- *Presence of IVC filter and or iliocaval stents
- *History of heparin-induced thrombocytopenia (HIT)
- *Any contraindication to systemic or therapeutic doses of heparin or anticoagulants
- *Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated
- *Known allergy to any device component
- (*)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)
- *Life expectancy of < 90 days, as determined by Investigator
- *Female who is pregnant or nursing
- *Current participation in another investigational drug or device treatment study
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Piedmont Heart
Atlanta, Georgia, 30309
Northside Hospital
Atlanta, Georgia, 30342
Austin Heart
Austin, Texas, 78705
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Brigham and Women's Hospital
Boston, Massachusetts, 02215
TriHealth Hatton Research Institute
Cincinnati, Ohio, 45242
Baylor Scott & White Research Institute
Dallas, Texas, 75204
Delray Medical Center
Delray Beach, Florida, 33484
UT Health
Houston, Texas, 77030
Indiana University
Indianapolis, Indiana, 46202
Baptist Health Research Institute
Jacksonville, Florida, 32207
HCA Florida Memorial Hospital
Jacksonville, Florida, 32216
Wellmont Cardiology Services / Ballad Health
Kingsport, Tennessee, 37660
Tennova Healthcare - Turkey Creek Medical Center
Knoxville, Tennessee, 37934
Gundersen Health
La Crosse, Wisconsin, 54601
PIH Health Good Samaritan Hospital
Los Angeles, California, 90017
Huntington Hospital
Pasadena, California, 91105
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Temple University
Philadelphia, Pennsylvania, 19122
The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, 90502
Torrance Memorial Medical Center
Torrance, California, 90505
About this study
Official title: 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).
- Conditions
- Pulmonary Embolism
- Being tested
- Hēlo PE Thombectomy System
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hēlo PE Thombectomy SystemDevice
Treatment with the Hēlo PE Thombectomy System for thromboembolectomy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Hēlo PE Thombectomy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 48 hours following the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start12 Jan 2023
- Primary completion2 Mar 2026
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endovascular Engineering
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Klein, MD, Principal investigator, Piedmont HeartJulie Bulman, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05597891
- Sponsor's protocol ID
- CLN01001
- Acronym
- ENGULF
- Status last verified
- Apr 2026
- First submitted
- 14 Oct 2022
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Feasibility Single-Arm Study of a Novel Catheter Thrombectomy Device For the Treatment of Pulmonary Embolism (ENGULF)
- ClinicalTrials.gov ID
- NCT05597891
- Acronym / sponsor ID
- ENGULF / CLN01001
- Conditions
- Pulmonary Embolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Endovascular EngineeringIndustry (pharma, biotech, devices)
- Study start
- 12 Jan 2023 (actual)
- Primary completion
- 2 Mar 2026 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 28 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of initial safety and clinical feasibility of the Hēlo PE Thrombectomy System for thrombectomy in acute submassive pulmonary embolism (PE).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Investigational Device | Experimental | Device: Hēlo PE Thombectomy SystemThe 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (31 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hēlo PE Thombectomy SystemTreatment with the Hēlo PE Thombectomy System for thromboembolectomy | Device | Investigational Device |
Primary outcome
Primary Safety Objective
Time frame: 48 hours following the procedure
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
Primary Performance Objective
Time frame: 48 hours following the procedure
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Klein, MD principal investigator
Piedmont Heart
Julie Bulman, MD principal investigator
Beth Israel Deaconess Medical Center
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hēlo PE Thombectomy System in people with Pulmonary Embolism, run by Endovascular Engineering at 21 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Objective (time frame: 48 hours following the procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.