Evaluation of the Magneto eTrieve™ PE Kit for Endovascular Thrombectomy in Subjects With Acute Pulmonary Embolism

Pulmonary Embolism Clinical Trial

— eTrieve II  

Official title:

Evaluation of the Safety and Effectiveness of Magneto eTrieve™ PE Kit for Endovascular Thrombectomy in Subjects With Acute Pulmonary Embolism

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05821426
• Other study ID #: KT1-CLN010
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: August 2025

Study information

• Verified date: March 2024
• Source: Magneto Thrombectomy Solutions
• Contact: Tami Abudi
• Phone: +972 (52) 5989833
• Email: tami[@]magts.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective, multi-center, open-label, single-arm clinical study of the safety and effectiveness of the eTrieve™ in subjects presenting with signs and symptoms of acute intermediate-risk pulmonary embolism

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: August 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years

• Clinical signs, symptoms, and presentation consistent with acute pulmonary embolism (PE)

• PE symptom duration = 14 days

• Filling defect in at least one main or lobar pulmonary artery on CTA

• Right ventricle / left ventricle (RV/LV) ratio = 0.9 on CTA (Investigator's reading)

• Systolic blood pressure = 90 mmHg

• Stable heart rate < 130 BPM prior to the index procedure

• Anatomy that, in the opinion of the interventionalist, allows safe passage of the eTrieve™ catheters

• Written informed consent

Exclusion Criteria:

• Patients with a combined reason for their decompensation (e.g., a patient with both sepsis and PE)

• PE within 3 months prior to screening assessment

• Thrombolytic use within 30 days prior to baseline CTA

• Pulmonary hypertension with peak systolic PAP > 70 mmHg

• Inotrope or vasopressor requirement after fluid administration to keep the systolic blood pressure = 90 mmHg

• Fraction of inspired Oxygen (FiO2) requirement > 40% or supplemental oxygen > 6 LPM to keep oxygen saturation > 90%

• Any of the following laboratory findings (within 6 hours prior to index procedure):

1. Hematocrit < 28%

2. Platelets < 100,000/µL

3. Serum creatinine > 1.8 mg/dL

4. INR > 3

• Major trauma Injury Severity Score (ISS) > 15 within 14 days prior to screening assessment

• Intracardiac lead in right ventricle, right atrium or coronary sinus, placed within 6 months prior to screening assessment

• Known presence of intracardiac clot

• Cardiovascular or pulmonary surgery within last 7 days

• Active malignancy and / or on chemotherapy

• Known bleeding diathesis or coagulation disorder

• Left bundle branch block

• History of severe or chronic pulmonary arterial hypertension

• History of left ventricular ejection fraction = 30%

• History of decompensated heart failure

• History of underlying oxygen dependent lung disease

• History of chest irradiation

• History of Heparin Induced Thrombocytopenia (HIT)

• Any contraindication to systemic therapeutic doses of heparin or other anticoagulants

• Known anaphylactic reaction to radiographic contrast agents that cannot be adequately pre-medicated

• Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically

• Imaging evidence or other evidence that suggests, in the opinion of the investigator, the subject is not appropriate for mechanical thrombectomy intervention

• Life expectancy of < 90 days as determined by the investigator

• Co-morbid condition(s) that, in the opinion of the investigator, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study

• Female who is pregnant or nursing

• Current participation in another investigational drug or device treatment study

• Previous enrollment in the eTrieve™ II Study

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

Device:
• eTrieve PE Kit
Patients will be treated with the eTrieve PE Kit

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Magneto Thrombectomy Solutions

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MAE	Number of Major Adverse Event (MAE) within 48 hours post-index procedure, as adjudicated by the Clinical Events Committee (CEC)	48 hours
Primary	RV/LV ratio	Change in RV/LV ratio from baseline to 48 hours post-index procedure (or discharge, whichever occurs first) as assessed by the CTA core laboratory	48 hours
Secondary	Use of thrombolytics	Use of thrombolytics within 48 hours post-index procedure	within 48 hours
Secondary	ICU/hospitalization length	Length of stay in the Intensive Care Unit (ICU)/hospital, associated with the index thrombectomy procedure	within 30 days
Secondary	Modified Miller score	Change in the Modified Miller Score between baseline and 48 hours post-index procedure as assessed by the CTA core laboratory	at 48 hours
Secondary	Mortality	Mortality due to any cause within 30 days post-index procedure	within 30 days
Secondary	Device related SAE	Device-related serious adverse events within 30 days post-index procedure, as adjudicated by the CEC	within 30 days
Secondary	PE reocurrence	Symptomatic PE recurrence within 30 days post-index procedure	within 30 days