Clinical trial NCT05560763: FlowTriever2 Pulmonary Embolectomy Clinical Study
Official title: FlowTriever Pulmonary Embolectomy Clinical Study - FlowTriever2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Embolism
Lead sponsor: Inari Medical
Sponsor class: INDUSTRY
First posted: 2022-09-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Number of Patient Mortalities (48 hours)
timeFrame: 48 hours post procedure
measure: Number of Major Bleeding Occurrences
timeFrame: 48 hours post procedure
measure: Primary Safety: Serious Adverse Event 3
timeFrame: Up to 30 days post procedure
measure: Effectiveness: Change in Mean Pulmonary Arterial Pressure (mmHg)
timeFrame: During procedure
Secondary outcomes:
measure: Number of Patient Mortalities (30 days)
timeFrame: Up to 30 days post procedure
measure: Number of Device-Related Serious Adverse Events
timeFrame: Up to 30 days post procedure
measure: Number of recurrences of PE
timeFrame: Up to 30 days post procedure
measure: Change in Systolic Pulmonary Arterial Pressure (mmHg)
timeFrame: During procedure
measure: Number of Adjunctive Thrombolytic Uses
timeFrame: During procedure
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Carondelet St. Joseph's Hospital
state: Arizona
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Savannah
country: United States
facility: Memorial Health University Medical Center
state: Georgia
city: Louisville
country: United States
facility: Baptist Health
state: Kentucky
city: Camden
country: United States
facility: Virtua Health
state: New Jersey
city: Tulsa
country: United States
facility: Oklahoma Heart Institute
state: Oklahoma
city: Knoxville
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
Study officials:
References: