RecruitingNot ApplicableNCT05597891
Endovascular Engineering ENGULF Study
A Safety and Feasibility Single-Arm Study of a Novel Catheter Thrombectomy Device For the Treatment of Pulmonary Embolism (ENGULF)
Sponsor
Endovascular Engineering
Enrollment
181 participants
Start Date
Jan 12, 2023
Study Type
INTERVENTIONAL
Conditions
Summary
Evaluation of initial safety and clinical feasibility of the Hēlo PE Thrombectomy System for thrombectomy in acute submassive pulmonary embolism (PE).
Eligibility
Min Age: 18 YearsMax Age: 90 Years
Inclusion Criteria10
- Asterisks * indicate entry criteria that can be evaluated during prescreening without obtaining informed consent as they are part of standard of care PE management. Asterisks in parenthesis (*) indicate entry criteria that can be evaluated during prescreening without obtaining informed consent at Sites that routinely perform CTA as part of standard of care in PE management.
- 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
Exclusion Criteria31
- 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
- *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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
DEVICEHēlo PE Thombectomy System
Treatment with the Hēlo PE Thombectomy System for thromboembolectomy
Locations(19)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05597891
Related Trials
Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy
NCT0559111840 locations
Emergency Medicine Pulmonary Embolism Testing Multicentre Study
NCT063202364 locations
Post-Market Celect Platinum Vena Cava Filter and Gunther Tulip Retrieval Set Study
NCT058817987 locations
Ultrasound-assisted, Catheter-directed Thrombolysis for Acute Intermediate-high-risk Pulmonary Embolism
NCT061439691 location
Data Clustering Study With Artificial Intelligence and Phenotyping of Patients With Acute Pulmonary Embolism
NCT061839441 location