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

NCT05821426 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: KT1-CLN010
• Study Type: interventional
• Target: 130
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Pulmonary Embolism

Keywords

Pulmonary Embolism; eTrieve

Outcome Measures

Primary Outcomes (2)

• MAE

  Number of Major Adverse Event (MAE) within 48 hours post-index procedure, as adjudicated by the Clinical Events Committee (CEC)

  48 hours

• 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 Outcomes (6)

• Use of thrombolytics

  within 48 hours

• ICU/hospitalization length

  within 30 days

• Modified Miller score

  at 48 hours

• Mortality

  within 30 days

• Device related SAE

  within 30 days

Study Arms (1)

eTrieve PE Kit

EXPERIMENTAL

Device: eTrieve PE Kit

Interventions

eTrieve PE Kit DEVICE

Patients will be treated with the eTrieve PE Kit

eTrieve PE Kit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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):
• Hematocrit \< 28%
• Platelets \< 100,000/µL
• Serum creatinine \> 1.8 mg/dL
• 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

Sponsors & Collaborators

• Magneto Thrombectomy Solutions: lead

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Tami Abudi

CONTACT

+972 (52) 5989833; tami@magts.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2023
• First Posted: April 20, 2023
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: September 29, 2025

Record last verified: 2025-09