FlowTriever2 Pulmonary Embolectomy Clinical Study

Pulmonary Embolism Clinical Trial

— FLARE-FT2  

Official title:

FlowTriever Pulmonary Embolectomy Clinical Study - FlowTriever2

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05560763
• Other study ID #: 21-001
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 14, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: December 2023
• Source: Inari Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: May 31, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

Device:
• FlowTriever2 Catheter
The FlowTriever2 Catheter is utilized for the treatment of Pulmonary Embolism

Locations

Country	Name	City	State
United States	Virtua Health	Camden	New Jersey
United States	University of Tennessee Medical Center	Knoxville	Tennessee
United States	Baptist Health	Louisville	Kentucky
United States	Yale University	New Haven	Connecticut
United States	Memorial Health University Medical Center	Savannah	Georgia
United States	Carondelet St. Joseph's Hospital	Tucson	Arizona
United States	Oklahoma Heart Institute	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Inari Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patient Mortalities (48 hours)	Mortality through 48 hours after the index procedure related to FlowTriever2 Catheter	48 hours post procedure
Primary	Number of Major Bleeding Occurrences	Major bleeding through 48 hours after the index procedure related to FlowTriever2 Catheter	48 hours post procedure
Primary	Primary Safety: Serious Adverse Event 3	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	Up to 30 days post procedure
Primary	Effectiveness: Change in Mean Pulmonary Arterial Pressure (mmHg)	The study's primary effectiveness endpoint is the change in mean pulmonary arterial pressure from baseline pre-procedure and post-procedure.	During procedure
Secondary	Number of Patient Mortalities (30 days)	All-cause mortality through the 30-day visit (visit window = 30 days from procedure -5 / +15 days)	Up to 30 days post procedure
Secondary	Number of Device-Related Serious Adverse Events	Number of device-related SAE through the 30-day visit (visit window = 30 days from procedure -5 / +15 days)	Up to 30 days post procedure
Secondary	Number of recurrences of PE	Symptomatic recurrence of pulmonary embolism through the 30-day visit (visit window = 30 days from procedure -5 / +15 days)	Up to 30 days post procedure
Secondary	Change in Systolic Pulmonary Arterial Pressure (mmHg)	The change in systolic pulmonary arterial pressure from baseline pre-procedure to post-procedure	During procedure
Secondary	Number of Adjunctive Thrombolytic Uses	Incidence of adjunctive thrombolytic use	During procedure