Endovascular Engineering ENGULF Study

Pulmonary Embolism Clinical Trial

— ENGULF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05597891
• Other study ID #: CLN01001
• Status: Recruiting
• Phase: N/A
• Start date: January 12, 2023
• Est. completion date: September 30, 2025

Study information

• Verified date: January 2024
• Source: Endovascular Engineering
• Contact: Patricia Chu
• Phone: 3103089089
• Email: pchu[@]endovascularengineering.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 181
• Est. completion date: September 30, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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 > 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:

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

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

Device:
• Viper Catheter System
Treatment with the Viper Catheter System for thromboembolectomy

Locations

Country	Name	City	State
United States	Piedmont Heart	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Endovascular Engineering

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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