CompletedNot Applicable

Endovascular Engineering ENGULF Study

United States177 participantsStarted 2023-01-12

Plain-language summary

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

Who can participate

Age range18 Years – 90 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. \*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

Exclusion criteria

✕. \*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

What they're measuring

Primary Safety Objective

Timeframe: 48 hours following the procedure

Primary Performance Objective

Timeframe: 48 hours following the procedure

Trial details

NCT IDNCT05597891

SponsorEndovascular Engineering

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03-02

View on ClinicalTrials.gov More Pulmonary Embolism trials