The FLARE-FT2 confirmatory study is a prospective, single-arm, multicenter study of the FlowTriever2 Catheter for mechanical thrombectomy of pulmonary embolism (PE).
The study is a prospective, single-arm, multicenter study to evaluate the safety and effectiveness of the FlowTriever2 Catheter for mechanical thrombectomy in patients eligible for endovascular treatment of acute pulmonary embolism (PE). The subjects who meet the inclusion/exclusion criteria will be enrolled in the study. The enrollment period is over a period of approximately 12 months. All study subjects actively participate through the 30-day visit (-5 / +15 days) following treatment. Study participation includes screening, baseline, treatment, 48-hour visit, and 30-day follow-up. The study population consists of subjects that have an acute PE. Subject eligibility is determined based on data available to the Investigator at the time of enrollment. Subjects must meet all inclusion and no exclusion criteria to be eligible for the study. All subjects that complete the procedure and the follow-ups are included in the analysis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
The FlowTriever2 Catheter is utilized for the treatment of Pulmonary Embolism via mechanical thrombectomy of thrombus in the pulmonary arteries.
Carondelet St. Joseph's Hospital
Tucson, Arizona, United States
Yale University
New Haven, Connecticut, United States
Memorial Health University Medical Center
Savannah, Georgia, United States
Baptist Health
Louisville, Kentucky, United States
Primary Safety Endpoint (Composite): Incidence of Adjudicated Serious Adverse Events (SAE)
Incidence of adjudicated Serious Adverse Events (SAE), which is a composite of: * Mortality through 48 hours after the index procedure related to FlowTriever2 Catheter * Major bleeding through 48 hours after the index procedure related to FlowTriever2 Catheter * 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: Device-related mortality and device-related major bleeding components assessed through 48 hours after index procedure. Intra-procedural device or procedure-related AE component assessed until index procedure completion (index procedure: approx. 50 mins).
Primary Effectiveness Endpoint: Change in Mean Pulmonary Arterial Pressure (mmHg)
Change in mean pulmonary arterial pressure measured via right heart catheterization at the beginning of the treatment procedure and at the end of the treatment procedure.
Time frame: Intraprocedural (at beginning and end of treatment procedure (index procedure: approximately 50 minutes))
Secondary Safety Endpoint: Number of Patient Mortalities
Number of adjudicated all-cause mortalities through the 30-day visit (visit window = 30 days from procedure -5 / +15 days)
Time frame: 30 days post procedure (-5 / +15 days)
Secondary Safety Endpoint: Number of Device-Related Serious Adverse Events
Number of adjudicated device-related SAE through the 30-day visit (visit window = 30 days from procedure -5 / +15 days)
Time frame: 30 days post procedure (-5 / +15 days)
Secondary Safety Endpoint: Number of Symptomatic Recurrences of PE
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Virtua Health
Camden, New Jersey, United States
Oklahoma Heart Institute
Tulsa, Oklahoma, United States
University of Tennessee Medical Center
Knoxville, Tennessee, United States
Number of adjudicated symptomatic recurrences of pulmonary embolism through the 30-day visit (visit window = 30 days from procedure -5 / +15 days)
Time frame: 30 days post procedure (-5 / +15 days)
Secondary Effectiveness Endpoint: Change in Systolic Pulmonary Arterial Pressure (mmHg)
Change in systolic pulmonary arterial pressure measured via right heart catheterization at the beginning of the treatment procedure and at the end of the treatment procedure
Time frame: Intraprocedural (at beginning and end of treatment procedure (index procedure: approximately 50 minutes))
Secondary Effectiveness Endpoint: Number of Patients With Adjunctive Thrombolytic Use
Number of patients who received adjunctive thrombolytic medication during the index procedure
Time frame: During Procedure (index procedure: approximately 50 minutes)