FlowTriever2 Pulmonary Embolectomy Clinical Study

Not Applicable

Completed

• Conditions: Pulmonary Embolism
• Interventions: Device: FlowTriever2 Catheter

• Registration Number: NCT05560763
• Lead Sponsor: Inari Medical

Brief Summary

The FLARE-FT2 confirmatory study is a prospective, single-arm, multicenter study of the FlowTriever2 Catheter.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-21
• Study First Submitted QC: 2022-09-27
• Study First Posted: 2022-09-29
• Study Start: 2023-02-14
• Primary Completion: 2024-09-09
• Study Completion: 2024-09-09
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-06
• Last Update Posted: 2025-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Clinical signs and symptoms consistent with acute PE
• PE symptom duration ≤ 14 days
• CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery)
• RV/LV ratio of ≥ 0.9 (NOTE: Enrollment qualification assessment based on Investigator's interpretation of RV/LV ratio)
• Systolic blood pressure ≥ 90 mmHg (initial SBP may be ≥ 80 mmHg if the pressure recovers to ≥ 90 mmHg with fluids)
• Stable heart rate < 130 BPM prior to procedure
• Patient is deemed medically eligible for interventional procedure(s), per institutional guidelines and/or clinical judgment.
• FlowTriever2 Catheter enters the vasculature

Exclusion Criteria

• Thrombolytic use within 30 days of baseline CTA
• Pulmonary hypertension with peak pulmonary artery 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
• INR > 3
• Major trauma Injury Severity Score (ISS) > 15
• Presence of intracardiac lead in the right ventricle or right atrium placed within 6 months
• Cardiovascular or pulmonary surgery within last 7 days
• Actively progressing cancer
• Known bleeding diathesis or coagulation disorder
• Left bundle branch block
• History of severe or chronic 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
• History of chest irradiation
• History of heparin-induced thrombocytopenia (HIT) Any contraindication to systemic or therapeutic doses heparin or anticoagulants
• Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Completed Cases	FlowTriever2 Catheter	-

Primary Outcome Measures

Name	Time	Method
Primary Safety: Serious Adverse Event 3	Up to 30 days post procedure	Intra-procedural device or procedure-related adverse events, including: * Clinical deterioration defined by hemodynamic or respiratory worsening; * Pulmonary vascular injury related to FlowTriever2 Catheter; * Cardiac injury related to FlowTriever2 Catheter
Effectiveness: Change in Mean Pulmonary Arterial Pressure (mmHg)	During procedure	The study's primary effectiveness endpoint is the change in mean pulmonary arterial pressure from baseline pre-procedure and post-procedure.
Number of Patient Mortalities (48 hours)	48 hours post procedure	Mortality through 48 hours after the index procedure related to FlowTriever2 Catheter
Number of Major Bleeding Occurrences	48 hours post procedure	Major bleeding through 48 hours after the index procedure related to FlowTriever2 Catheter

Secondary Outcome Measures

Name	Time	Method
Number of Patient Mortalities (30 days)	Up to 30 days post procedure	All-cause mortality through the 30-day visit (visit window = 30 days from procedure -5 / +15 days)
Number of Device-Related Serious Adverse Events	Up to 30 days post procedure	Number of device-related SAE through the 30-day visit (visit window = 30 days from procedure -5 / +15 days)
Number of recurrences of PE	Up to 30 days post procedure	Symptomatic recurrence of pulmonary embolism through the 30-day visit (visit window = 30 days from procedure -5 / +15 days)
Number of Adjunctive Thrombolytic Uses	During procedure	Incidence of adjunctive thrombolytic use
Change in Systolic Pulmonary Arterial Pressure (mmHg)	During procedure	The change in systolic pulmonary arterial pressure from baseline pre-procedure to post-procedure

Trial Locations

Locations (7)

Memorial Health University Medical Center; 🇺🇸 Savannah, Georgia, United States

Virtua Health; 🇺🇸 Camden, New Jersey, United States

Carondelet St. Joseph's Hospital; 🇺🇸 Tucson, Arizona, United States

Oklahoma Heart Institute; 🇺🇸 Tulsa, Oklahoma, United States

University of Tennessee Medical Center; 🇺🇸 Knoxville, Tennessee, United States

Baptist Health; 🇺🇸 Louisville, Kentucky, United States

Yale University; 🇺🇸 New Haven, Connecticut, United States