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FlowTriever Pulmonary Embolectomy Clinical Study (FLARE)

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ClinicalTrials.gov Identifier: NCT02692586
Recruitment Status : Completed
First Posted : February 26, 2016
Results First Posted : April 29, 2021
Last Update Posted : May 24, 2021
Sponsor:
Information provided by (Responsible Party):
Inari Medical

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Pulmonary Embolism
Acute Pulmonary Embolism
Submassive Pulmonary Embolism
Massive Pulmonary Embolism
Intervention Device: FlowTriever System
Enrollment 106
Recruitment Details  
Pre-assignment Details  
Arm/Group Title FlowTriever System
Hide Arm/Group Description FlowTriever System
Period Title: Overall Study
Started 106
Completed 103
Not Completed 3
Reason Not Completed
Death from undiagnosed breast cancer through 30-day follow-up             1
Received adjunctive thrombolytics             2
Arm/Group Title FlowTriever System
Hide Arm/Group Description FlowTriever System
Overall Number of Baseline Participants 104
Hide Baseline Analysis Population Description
Measure Analysis Population Description: Measure Analysis Population Description: Study subjects with no thrombolytic agents administered during the index procedure (n = 104).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 104 participants
55.6  (13.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants
Female
48
  46.2%
Male
56
  53.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
103
  99.0%
Unknown or Not Reported
1
   1.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
1
   1.0%
Black or African American
17
  16.3%
White
86
  82.7%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Pre-procedural RV/LV ratio  
Mean (Standard Deviation)
Unit of measure:  Ratio
Number Analyzed 104 participants
1.56  (0.34)
1.Primary Outcome
Title Change in RV/LV Ratio
Hide Description Change in RV/LV ratio from baseline to 48 hours
Time Frame Baseline to 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with symptomatic, computed tomography-documented PE and RV/LV ratios ≥ 0.9 treated with the FlowTriever System that were not administered thrombolytic agents during the index procedure (n = 104)
Arm/Group Title FlowTriever System
Hide Arm/Group Description:
Patients treated with the FlowTriever System
Overall Number of Participants Analyzed 104
Mean (Standard Error)
Unit of Measure: RV/LV ratio
0.38  (0.03)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FlowTriever System
Comments [Not Specified]
Type of Statistical Test Superiority
Comments To detect an RV/LV ratio change > 0.12 with a power of 80% at one-sided alpha = 0.025, the necessary sample size was calculated to be ≥ 52, 31, or 21 patients (to detect RV/LV ratio changes of 0.20, 0.225, or 0.25, respectively).
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
2.Primary Outcome
Title Number of Participants With Major Adverse Events
Hide Description Device-related death, major bleeding, and treatment related AEs
Time Frame Within 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with symptomatic, computed tomography-documented PE and RV/LV ratios ≥ 0.9 treated with the FlowTriever System that were not administered thrombolytic agents during the index procedure (n = 104)
Arm/Group Title FlowTriever System
Hide Arm/Group Description:
Patients treated with the FlowTriever System
Overall Number of Participants Analyzed 104
Measure Type: Count of Participants
Unit of Measure: Participants
Participants experiencing MAEs
4
   3.8%
Participants not experiencing MAEs
100
  96.2%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FlowTriever System
Comments [Not Specified]
Type of Statistical Test Superiority
Comments The hypothesized composite MAE rate was expected to be about 13%. The necessary sample size to detect a difference from an expected MAE rate of 13% with 80% power was calculated to be 103 patients (with a one-sided p value = 0.05).
Statistical Test of Hypothesis P-Value < 0.0001
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
Time Frame 30 +/- 3 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title FlowTriever System
Hide Arm/Group Description FlowTriever System
All-Cause Mortality
FlowTriever System
Affected / at Risk (%)
Total   1/106 (0.94%)    
Hide Serious Adverse Events
FlowTriever System
Affected / at Risk (%) # Events
Total   14/106 (13.21%)    
Blood and lymphatic system disorders   
Anemia   1/106 (0.94%)  2
Heparin-induced thrombocytopenia   1/106 (0.94%)  1
Cardiac disorders   
Atrial fibrillation   1/106 (0.94%)  1
Coronary artery stenosis   1/106 (0.94%)  1
Myocardial ischaemia   1/106 (0.94%)  1
Congenital, familial and genetic disorders   
Gastrointestinal arteriovenous malformation   1/106 (0.94%)  1
Gastrointestinal disorders   
Gastrointestinal haemorrhage   1/106 (0.94%)  1
Ileus   1/106 (0.94%)  1
Intestinal obstruction   1/106 (0.94%)  1
General disorders   
Catheter site hematoma   1/106 (0.94%)  1
Infections and infestations   
Pneumonia   1/106 (0.94%)  1
Respiratory tract infection   1/106 (0.94%)  1
Sepsis   1/106 (0.94%)  1
Injury, poisoning and procedural complications   
Postoperative renal failure   1/106 (0.94%)  1
Road traffic accident   1/106 (0.94%)  1
Metabolism and nutrition disorders   
Acute respiratory failure   1/106 (0.94%)  1
Respiratory failure   1/106 (0.94%)  1
Respiratory, thoracic and mediastinal disorders   
Pleural effusion   1/106 (0.94%)  1
Pneumonia aspiration   1/106 (0.94%)  1
Pulmonary embolism   2/106 (1.89%)  2
Pulmonary hemorrhage   1/106 (0.94%)  1
Pulmonary infarction   1/106 (0.94%)  1
Respiratory arrest   2/106 (1.89%)  2
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
FlowTriever System
Affected / at Risk (%) # Events
Total   0/106 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ashleigh Willson
Organization: Inari Medical
Phone: 877-923-4747
EMail: ashleigh.willson@inarimedical.com
Layout table for additonal information
Responsible Party: Inari Medical
ClinicalTrials.gov Identifier: NCT02692586    
Other Study ID Numbers: 15-001
First Submitted: February 23, 2016
First Posted: February 26, 2016
Results First Submitted: April 2, 2021
Results First Posted: April 29, 2021
Last Update Posted: May 24, 2021