FlowTriever2 Pulmonary Embolectomy Clinical Study (FLARE-FT2)
Primary Purpose
Pulmonary Embolism
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FlowTriever2 Catheter
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Embolism
Eligibility Criteria
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
Sites / Locations
- Yale University
- Baptist Health
- Virtua Health
- Oklahoma Heart Institute
- University of Tennessee Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Completed Cases
Arm Description
Outcomes
Primary Outcome Measures
Number of Patient Mortalities (48 hours)
Mortality through 48 hours after the index procedure related to FlowTriever2 Catheter
Number of Major Bleeding Occurrences
Major bleeding through 48 hours after the index procedure related to FlowTriever2 Catheter
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
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.
Secondary Outcome Measures
Number of Patient Mortalities (30 days)
All-cause mortality through the 30-day visit (visit window = 30 days from procedure -5 / +15 days)
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)
Number of recurrences of PE
Symptomatic recurrence of pulmonary embolism through the 30-day visit (visit window = 30 days from procedure -5 / +15 days)
Change in Systolic Pulmonary Arterial Pressure (mmHg)
The change in systolic pulmonary arterial pressure from baseline pre-procedure to post-procedure
Number of Adjunctive Thrombolytic Uses
Incidence of adjunctive thrombolytic use
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05560763
Brief Title
FlowTriever2 Pulmonary Embolectomy Clinical Study
Acronym
FLARE-FT2
Official Title
FlowTriever Pulmonary Embolectomy Clinical Study - FlowTriever2
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 14, 2023 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inari Medical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The FLARE-FT2 confirmatory study is a prospective, single-arm, multicenter study of the FlowTriever2 Catheter.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Completed Cases
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
FlowTriever2 Catheter
Intervention Description
The FlowTriever2 Catheter is utilized for the treatment of Pulmonary Embolism
Primary Outcome Measure Information:
Title
Number of Patient Mortalities (48 hours)
Description
Mortality through 48 hours after the index procedure related to FlowTriever2 Catheter
Time Frame
48 hours post procedure
Title
Number of Major Bleeding Occurrences
Description
Major bleeding through 48 hours after the index procedure related to FlowTriever2 Catheter
Time Frame
48 hours post procedure
Title
Primary Safety: Serious Adverse Event 3
Description
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
Time Frame
Up to 30 days post procedure
Title
Effectiveness: Change in Mean Pulmonary Arterial Pressure (mmHg)
Description
The study's primary effectiveness endpoint is the change in mean pulmonary arterial pressure from baseline pre-procedure and post-procedure.
Time Frame
During procedure
Secondary Outcome Measure Information:
Title
Number of Patient Mortalities (30 days)
Description
All-cause mortality through the 30-day visit (visit window = 30 days from procedure -5 / +15 days)
Time Frame
Up to 30 days post procedure
Title
Number of Device-Related Serious Adverse Events
Description
Number of device-related SAE through the 30-day visit (visit window = 30 days from procedure -5 / +15 days)
Time Frame
Up to 30 days post procedure
Title
Number of recurrences of PE
Description
Symptomatic recurrence of pulmonary embolism through the 30-day visit (visit window = 30 days from procedure -5 / +15 days)
Time Frame
Up to 30 days post procedure
Title
Change in Systolic Pulmonary Arterial Pressure (mmHg)
Description
The change in systolic pulmonary arterial pressure from baseline pre-procedure to post-procedure
Time Frame
During procedure
Title
Number of Adjunctive Thrombolytic Uses
Description
Incidence of adjunctive thrombolytic use
Time Frame
During procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
Baptist Health
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Virtua Health
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Oklahoma Heart Institute
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
University of Tennessee Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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FlowTriever2 Pulmonary Embolectomy Clinical Study
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