A Safety and Feasibility Single-Arm Study of a Novel Catheter Thrombectomy Device For the Treatment of Pulmonary Embolism

Study Overview
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Brief Summary
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Evaluation of initial safety and clinical feasibility of the Viper Catheter System for thrombectomy in acute submassive pulmonary embolism (PE).

Official Title
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A Safety and Feasibility Single-Arm Study of a Novel Catheter Thrombectomy Device For the Treatment of Pulmonary Embolism (ENGULF)

Conditions
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Pulmonary Embolism

Intervention / Treatment
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* Device: Viper Catheter System


Participation Criteria
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Eligibility Criteria
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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. Inclusion Criteria: Patients must meet ALL of the following criteria to be eligible for participation in the study: *Patient is > 22 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, or authorized representative, 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: *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 6 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 underlying lung disease that is oxygen dependent *History of chest irradiation *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 *Morbid obesity defined as BMI > 45

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational Device<br> | Device: Viper Catheter System<br>* Treatment with the Viper Catheter System for thromboembolectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Technical Success, defined as Viper Catheter System ability to perform all the following functions without device malfunctions: Ability to access the site of the embolism with the Viper Catheter System; Ability to position the Viper Catheter System and expand the funnel at the site of embolism; Ability to remove target thrombus without adjunctive treatment for the purpose of reducing clot burden; and Ability to retrieve and remove the Viper Catheter System intact | Within 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary 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 |