FLARE: FlowTriever Pulmonary Embolectomy Clinical Study

• Sponsor: Inari Medical (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02692586
• Collaborator: (none)
• Enrollment: 106
• Locations: 18
• Arm: 1
• Duration (Months): 19
• Patients Per Site: 5.9
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

Evaluate the safety and effectiveness of the FlowTriever System for use in the removal of emboli from the pulmonary arteries in the treatment of acute pulmonary embolism.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Embolism; Acute Pulmonary Embolism; Submassive Pulmonary Embolism; Massive Pulmonary Embolism	Device: FlowTriever System	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 106 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: FlowTriever Pulmonary Embolectomy Clinical Study
• Study Start Date: Apr 1, 2016
• Actual Primary Completion Date: Nov 1, 2017
• Actual Study Completion Date: Nov 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: FlowTriever System	Device: FlowTriever System

Outcome Measures

Primary Outcome Measures

1. Change in RV/LV Ratio [Baseline to 48 hours]

   Change in RV/LV ratio from baseline to 48 hours

2. Number of Participants With Major Adverse Events [Within 48 hours]

   Device-related death, major bleeding, and treatment related AEs

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Clinical signs, symptoms and presentation consistent with acute PE

• PE symptom duration ≤ 14 days

• CTA evidence of proximal PE

• RV/LV ratio ≥ 0.9 without syncope

• Systolic BP ≥ 90 mmHg

• Stable heart rate <130 BPM prior to procedure

• Patient deemed medically eligible for interventional procedure(s), per institutional guidelines and/or clinical judgment

Exclusion Criteria:

• Thrombolytic use within 30 days of baseline CTA

• Pulmonary hypertension with peak PAP > 70 mmHg by right heart catheterization

• Vasopressor requirement after fluids to keep pressure ≥ 90 mm Hg

• FiO2 requirement > 40% or > 6 LPM to keep oxygen saturation > 90%

• Hematocrit < 28% within 6 hours of index procedure

• Platelets < 100,000/µL

• Serum creatinine > 1.8 mg/dL

• INR > 3

• Major trauma ISS > 15

• Presence of intracardiac lead in right ventricle or 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

• Any contraindication to systemic or therapeutic doses of heparin or anticoagulants

• Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated

• Imaging evidence or other evidence that suggests the subject is not appropriate for mechanical thrombectomy intervention

• Life expectancy of < 90 days

• Female who is pregnant or nursing

• Current participation in another investigational drug or device treatment study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	East Alabama Heart & Vascular	Auburn	Alabama	United States
2	St. Vincent's	Birmingham	Alabama	United States
3	Cedars-Sinai Medical Center	Los Angeles	California	United States
4	Florida Hospital	Orlando	Florida	United States
5	Sacred Heart Hospital	Pensacola	Florida	United States
6	Tampa General Hospital	Tampa	Florida	United States
7	Emory University	Atlanta	Georgia	United States
8	Ephraim McDowell Regional Medical Center	Danville	Kentucky	United States
9	Baptist Health	Louisville	Kentucky	United States
10	East Jefferson General Hospital	Metairie	Louisiana	United States
11	North Shore University Hospital	Manhasset	New York	United States
12	Ohio State University	Columbus	Ohio	United States
13	OhioHealth Riverside Methodist Hospital	Columbus	Ohio	United States
14	UPMC Hamot	Erie	Pennsylvania	United States
15	Penn Presbyterian Medical Center	Philadelphia	Pennsylvania	United States
16	UPMC	Pittsburgh	Pennsylvania	United States
17	Houston Methodist Hospital	Houston	Texas	United States
18	Charleston Area Medical Center	Charleston	West Virginia	United States

Sponsors and Collaborators

• Inari Medical

Investigators

• Study Chair: Kenneth Rosenfield, MD, Massachusetts General Hospital
• Study Chair: Victor Tapson, MD, Cedars-Sinai Medical Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 30, 2016

More Information

Publications

None provided.

• Responsible Party: Inari Medical
• ClinicalTrials.gov Identifier: NCT02692586
• Other Study ID Numbers: 15-001
• First Posted: Feb 26, 2016
• Last Update Posted: May 24, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Inari Medical: Thromboembolism; Thrombectomy; Right Heart Strain; Submassive PE; Right Ventricle Dysfunction; Massive PE
• Additional relevant MeSH terms: Pulmonary Embolism; Embolism

Study Results

Participant Flow

Arm/Group Title	FlowTriever System
Arm/Group Description	FlowTriever System
Period Title: Overall Study
STARTED	106
COMPLETED	103
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	FlowTriever System
Arm/Group Description	FlowTriever System
Overall Participants	104
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55.6 (13.7)
Sex: Female, Male (Count of Participants)
Female	48 46.2%
Male	56 53.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	103 99%
Unknown or Not Reported	1 1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	1 1%
Black or African American	17 16.3%
White	86 82.7%
More than one race	0 0%
Unknown or Not Reported	0 0%
Pre-procedural RV/LV ratio (ratio) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [ratio]	1.56 (0.34)

Outcome Measures

1. Primary Outcome

Title	Change in RV/LV Ratio
Description	Change in RV/LV ratio from baseline to 48 hours
Time Frame	Baseline to 48 hours

Outcome Measure Data

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
Arm/Group Description	Patients treated with the FlowTriever System
Measure Participants	104
Mean (Standard Error) [RV/LV ratio]	0.38 (0.03)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	FlowTriever System
	Comments
	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
	Method	t-test, 1 sided
	Comments

2. Primary Outcome

Title	Number of Participants With Major Adverse Events
Description	Device-related death, major bleeding, and treatment related AEs
Time Frame	Within 48 hours

Outcome Measure Data

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
Arm/Group Description	Patients treated with the FlowTriever System
Measure Participants	104
Participants experiencing MAEs	4 3.8%
Participants not experiencing MAEs	100 96.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	FlowTriever System
	Comments
	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
	Method	t-test, 1 sided
	Comments

Adverse Events

Time Frame	30 +/- 3 days
Arm/Group Title	FlowTriever System
Arm/Group Description	FlowTriever System
All Cause Mortality
	FlowTriever System
	Affected / at Risk (%)	# Events
Total	1/106 (0.9%)
Serious Adverse Events
	FlowTriever System
	Affected / at Risk (%)	# Events
Total	14/106 (13.2%)
Blood and lymphatic system disorders
Anemia	1/106 (0.9%)	2
Heparin-induced thrombocytopenia	1/106 (0.9%)	1
Cardiac disorders
Atrial fibrillation	1/106 (0.9%)	1
Coronary artery stenosis	1/106 (0.9%)	1
Myocardial ischaemia	1/106 (0.9%)	1
Congenital, familial and genetic disorders
Gastrointestinal arteriovenous malformation	1/106 (0.9%)	1
Gastrointestinal disorders
Gastrointestinal haemorrhage	1/106 (0.9%)	1
Ileus	1/106 (0.9%)	1
Intestinal obstruction	1/106 (0.9%)	1
General disorders
Catheter site hematoma	1/106 (0.9%)	1
Infections and infestations
Pneumonia	1/106 (0.9%)	1
Respiratory tract infection	1/106 (0.9%)	1
Sepsis	1/106 (0.9%)	1
Injury, poisoning and procedural complications
Postoperative renal failure	1/106 (0.9%)	1
Road traffic accident	1/106 (0.9%)	1
Metabolism and nutrition disorders
Acute respiratory failure	1/106 (0.9%)	1
Respiratory failure	1/106 (0.9%)	1
Respiratory, thoracic and mediastinal disorders
Pleural effusion	1/106 (0.9%)	1
Pneumonia aspiration	1/106 (0.9%)	1
Pulmonary embolism	2/106 (1.9%)	2
Pulmonary hemorrhage	1/106 (0.9%)	1
Pulmonary infarction	1/106 (0.9%)	1
Respiratory arrest	2/106 (1.9%)	2
Other (Not Including Serious) Adverse Events
	FlowTriever System
	Affected / at Risk (%)	# Events
Total	0/106 (0%)

Limitations/Caveats

[Not Specified]

More Information

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.