Trial Outcomes & Findings for FlowTriever2 Pulmonary Embolectomy Clinical Study (NCT NCT05560763)

Last Updated: 2025-10-08

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

50 participants

Primary outcome timeframe

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).

Results posted on

2025-10-08

Participant Flow

All subjects presenting to the hospital/emergency department with a pulmonary embolism (PE) and meeting all eligibility requirements for enrollment in the FLARE-FT2 study.

Participant milestones

Participant milestones
Measure	All Subjects All participants who were treated with the FlowTriever System and FlowTriever2 Catheter for mechanical thrombectomy of PE.
Overall Study STARTED	50
Overall Study Enrollment Population	42
Overall Study Intent-to-Treat Population	42
Overall Study Modified Intent-to-Treat Population	42
Overall Study Full Analysis Set Population	42
Overall Study Completed Cases Population	38
Overall Study COMPLETED	46
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	All Subjects All participants who were treated with the FlowTriever System and FlowTriever2 Catheter for mechanical thrombectomy of PE.
Overall Study Withdrawal by Subject	4

Baseline Characteristics

This analysis is only applied to subjects that have a history of cancer (7).

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Subjects n=50 Participants All participants who were treated with the FlowTriever System and FlowTriever2 Catheter for mechanical thrombectomy of PE.
Age, Continuous	63 years n=50 Participants
Sex: Female, Male Female	20 Participants n=50 Participants
Sex: Female, Male Male	30 Participants n=50 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=50 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	46 Participants n=50 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=50 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=50 Participants
Race (NIH/OMB) Asian	0 Participants n=50 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=50 Participants
Race (NIH/OMB) Black or African American	12 Participants n=50 Participants
Race (NIH/OMB) White	37 Participants n=50 Participants
Race (NIH/OMB) More than one race	0 Participants n=50 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=50 Participants
Height (m)	1.75 m n=50 Participants
Weight (kg)	99.9 kg n=50 Participants
BMI (kg/m^2)	33.2 kg/m^2 n=50 Participants
Tobacco Use Current	12 Participants n=50 Participants
Tobacco Use Past	12 Participants n=50 Participants
Tobacco Use Never	26 Participants n=50 Participants
Prior Pulmonary Embolism (PE) Yes	8 Participants n=50 Participants
Prior Pulmonary Embolism (PE) No	42 Participants n=50 Participants
Prior deep venous thrombosis (DVT) Yes	14 Participants n=50 Participants
Prior deep venous thrombosis (DVT) No	36 Participants n=50 Participants
History of pulmonary hypertension Yes	2 Participants n=50 Participants
History of pulmonary hypertension No	48 Participants n=50 Participants
History of systemic hypertension Yes	28 Participants n=50 Participants
History of systemic hypertension No	22 Participants n=50 Participants
History of coronary artery disease (CAD) Yes	4 Participants n=50 Participants
History of coronary artery disease (CAD) No	46 Participants n=50 Participants
History of congestive heart failure (CHF) Yes	3 Participants n=50 Participants
History of congestive heart failure (CHF) No	47 Participants n=50 Participants
History of coronary artery bypass graft (CABG) Yes	0 Participants n=50 Participants
History of coronary artery bypass graft (CABG) No	50 Participants n=50 Participants
History of chronic obstructive pulmonary disease (COPD) Yes	4 Participants n=50 Participants
History of chronic obstructive pulmonary disease (COPD) No	46 Participants n=50 Participants
History of myocardial infarction (MI) Yes	2 Participants n=50 Participants
History of myocardial infarction (MI) No	48 Participants n=50 Participants
Patent foramen ovale (PFO) / shunt Yes	1 Participants n=50 Participants
Patent foramen ovale (PFO) / shunt No	49 Participants n=50 Participants
Prior cerebrovascular accident (prior stroke/transient ischemic attack (TIA)) Yes	1 Participants n=50 Participants
Prior cerebrovascular accident (prior stroke/transient ischemic attack (TIA)) No	49 Participants n=50 Participants
Hypercoagulable state Yes	0 Participants n=50 Participants
Hypercoagulable state No	50 Participants n=50 Participants
History of cancer Yes	7 Participants n=50 Participants
History of cancer No	43 Participants n=50 Participants
Active Cancer Yes	0 Participants n=7 Participants • This analysis is only applied to subjects that have a history of cancer (7).
Active Cancer No	7 Participants n=7 Participants • This analysis is only applied to subjects that have a history of cancer (7).
History of renal disease (chronic renal insufficiency) Yes	3 Participants n=50 Participants
History of renal disease (chronic renal insufficiency) No	47 Participants n=50 Participants
On dialysis Yes	0 Participants n=3 Participants • This analysis is only applied to subjects that have a history of renal disease (chronic renal insufficiency) (3).
On dialysis No	3 Participants n=3 Participants • This analysis is only applied to subjects that have a history of renal disease (chronic renal insufficiency) (3).
Recent surgery (within 30 days) Yes	6 Participants n=50 Participants
Recent surgery (within 30 days) No	44 Participants n=50 Participants
Recent surgery type Orthopedic	2 Participants n=6 Participants • This analysis is only applied to subjects that have had recent surgery (within the last 30 days) (6).
Recent surgery type Neurological	1 Participants n=6 Participants • This analysis is only applied to subjects that have had recent surgery (within the last 30 days) (6).
Recent surgery type Abdomen	1 Participants n=6 Participants • This analysis is only applied to subjects that have had recent surgery (within the last 30 days) (6).
Recent surgery type Other	2 Participants n=6 Participants • This analysis is only applied to subjects that have had recent surgery (within the last 30 days) (6).
Recent trauma (within 30 days) Yes	1 Participants n=50 Participants
Recent trauma (within 30 days) No	49 Participants n=50 Participants
Thrombolytic contraindication None	48 Participants n=50 Participants
Thrombolytic contraindication Relative	1 Participants n=50 Participants
Thrombolytic contraindication Absolute	1 Participants n=50 Participants
Relative thrombolytic contraindication Oral anticoagulation except for aspirin	1 Condition applies to subject n=1 Participants • This analysis is only applied to subjects that have relative thrombolytic contraindication (1).
Relative thrombolytic contraindication Therapeutic LMWH within 24 hours	1 Condition applies to subject n=1 Participants • This analysis is only applied to subjects that have relative thrombolytic contraindication (1).
Absolute thrombolytic contraindication with recent intracranial/spinal surgery or head trauma	1 Participants n=1 Participants • This analysis is only applied to subjects that have an absolute thrombolytic contraindication (1).
History of diabetes Yes	14 Participants n=50 Participants
History of diabetes No	36 Participants n=50 Participants
Diabetes type Diabetes mellitus type 1	1 Participants n=14 Participants • This analysis is only applied to subjects that have diabetes (14).
Diabetes type Diabetes mellitus type 2	13 Participants n=14 Participants • This analysis is only applied to subjects that have diabetes (14).
Current COVID-19 status COVID-19 positive	1 Participants n=50 Participants
Current COVID-19 status COVID-19 negative	12 Participants n=50 Participants
Current COVID-19 status COVID-19 status unknown	37 Participants n=50 Participants
Prior COVID-19 infection Previously recovered	6 Participants n=50 Participants
Prior COVID-19 infection Prior infection unknown	33 Participants n=50 Participants
Prior COVID-19 infection Not applicable	11 Participants n=50 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	All Subjects n=50 Participants All participants who were treated with the FlowTriever System and FlowTriever2 Catheter for mechanical thrombectomy of PE.
Primary Safety Endpoint (Composite): Incidence of Adjudicated Serious Adverse Events (SAE) Yes	0 Participants
Primary Safety Endpoint (Composite): Incidence of Adjudicated Serious Adverse Events (SAE) No	50 Participants

PRIMARY outcome

Timeframe: Intraprocedural (at beginning and end of treatment procedure (index procedure: approximately 50 minutes))

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.

Outcome measures

Outcome measures
Measure	All Subjects n=50 Participants All participants who were treated with the FlowTriever System and FlowTriever2 Catheter for mechanical thrombectomy of PE.
Primary Effectiveness Endpoint: Change in Mean Pulmonary Arterial Pressure (mmHg)	-5.50 mmHg Interval -29.0 to 15.0

SECONDARY outcome

Timeframe: 30 days post procedure (-5 / +15 days)

Number of adjudicated all-cause mortalities through the 30-day visit (visit window = 30 days from procedure -5 / +15 days)

Outcome measures

Outcome measures
Measure	All Subjects n=50 Participants All participants who were treated with the FlowTriever System and FlowTriever2 Catheter for mechanical thrombectomy of PE.
Secondary Safety Endpoint: Number of Patient Mortalities Yes	0 Participants
Secondary Safety Endpoint: Number of Patient Mortalities No	46 Participants
Secondary Safety Endpoint: Number of Patient Mortalities Withdrawn	4 Participants

SECONDARY outcome

Timeframe: 30 days post procedure (-5 / +15 days)

Number of adjudicated device-related SAE through the 30-day visit (visit window = 30 days from procedure -5 / +15 days)

Outcome measures

Outcome measures
Measure	All Subjects n=50 Participants All participants who were treated with the FlowTriever System and FlowTriever2 Catheter for mechanical thrombectomy of PE.
Secondary Safety Endpoint: Number of Device-Related Serious Adverse Events Yes	0 Participants
Secondary Safety Endpoint: Number of Device-Related Serious Adverse Events No	46 Participants
Secondary Safety Endpoint: Number of Device-Related Serious Adverse Events Withdrawn	4 Participants

SECONDARY outcome

Timeframe: 30 days post procedure (-5 / +15 days)

Number of adjudicated symptomatic recurrences of pulmonary embolism through the 30-day visit (visit window = 30 days from procedure -5 / +15 days)

Outcome measures

Outcome measures
Measure	All Subjects n=50 Participants All participants who were treated with the FlowTriever System and FlowTriever2 Catheter for mechanical thrombectomy of PE.
Secondary Safety Endpoint: Number of Symptomatic Recurrences of PE Yes	0 Participants
Secondary Safety Endpoint: Number of Symptomatic Recurrences of PE No	46 Participants
Secondary Safety Endpoint: Number of Symptomatic Recurrences of PE Withdrawn	4 Participants

SECONDARY outcome

Timeframe: Intraprocedural (at beginning and end of treatment procedure (index procedure: approximately 50 minutes))

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

Outcome measures

Outcome measures
Measure	All Subjects n=50 Participants All participants who were treated with the FlowTriever System and FlowTriever2 Catheter for mechanical thrombectomy of PE.
Secondary Effectiveness Endpoint: Change in Systolic Pulmonary Arterial Pressure (mmHg)	-8.00 mmHg Interval -37.0 to 17.0

SECONDARY outcome

Timeframe: During Procedure (index procedure: approximately 50 minutes)

Number of patients who received adjunctive thrombolytic medication during the index procedure

Outcome measures

Outcome measures
Measure	All Subjects n=50 Participants All participants who were treated with the FlowTriever System and FlowTriever2 Catheter for mechanical thrombectomy of PE.
Secondary Effectiveness Endpoint: Number of Patients With Adjunctive Thrombolytic Use Yes	0 Participants
Secondary Effectiveness Endpoint: Number of Patients With Adjunctive Thrombolytic Use No	50 Participants

Adverse Events

All Subjects

Serious events: 10 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	All Subjects n=50 participants at risk All participants who were treated with the FlowTriever System and FlowTriever2 Catheter for mechanical thrombectomy of PE.
Injury, poisoning and procedural complications Vascular access site haemorrhage	4.0% 2/50 • Number of events 2 • All AEs were followed by the Investigator until resolution or until the 30-day follow-up visit when the patient exited the study. Collection of adverse events started after the time that the informed consent form was signed and the subject was enrolled. Adverse events were monitored throughout the study up until each patient's exit from the study.
Injury, poisoning and procedural complications Vascular access site haematoma	2.0% 1/50 • Number of events 1 • All AEs were followed by the Investigator until resolution or until the 30-day follow-up visit when the patient exited the study. Collection of adverse events started after the time that the informed consent form was signed and the subject was enrolled. Adverse events were monitored throughout the study up until each patient's exit from the study.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	2.0% 1/50 • Number of events 1 • All AEs were followed by the Investigator until resolution or until the 30-day follow-up visit when the patient exited the study. Collection of adverse events started after the time that the informed consent form was signed and the subject was enrolled. Adverse events were monitored throughout the study up until each patient's exit from the study.
Respiratory, thoracic and mediastinal disorders Hypoxia	2.0% 1/50 • Number of events 1 • All AEs were followed by the Investigator until resolution or until the 30-day follow-up visit when the patient exited the study. Collection of adverse events started after the time that the informed consent form was signed and the subject was enrolled. Adverse events were monitored throughout the study up until each patient's exit from the study.
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.0% 1/50 • Number of events 1 • All AEs were followed by the Investigator until resolution or until the 30-day follow-up visit when the patient exited the study. Collection of adverse events started after the time that the informed consent form was signed and the subject was enrolled. Adverse events were monitored throughout the study up until each patient's exit from the study.
Vascular disorders Acute myocardial infarction	2.0% 1/50 • Number of events 1 • All AEs were followed by the Investigator until resolution or until the 30-day follow-up visit when the patient exited the study. Collection of adverse events started after the time that the informed consent form was signed and the subject was enrolled. Adverse events were monitored throughout the study up until each patient's exit from the study.
Vascular disorders Hypotension	2.0% 1/50 • Number of events 1 • All AEs were followed by the Investigator until resolution or until the 30-day follow-up visit when the patient exited the study. Collection of adverse events started after the time that the informed consent form was signed and the subject was enrolled. Adverse events were monitored throughout the study up until each patient's exit from the study.
General disorders Pain	2.0% 1/50 • Number of events 1 • All AEs were followed by the Investigator until resolution or until the 30-day follow-up visit when the patient exited the study. Collection of adverse events started after the time that the informed consent form was signed and the subject was enrolled. Adverse events were monitored throughout the study up until each patient's exit from the study.
Infections and infestations Osteomyelitis	2.0% 1/50 • Number of events 1 • All AEs were followed by the Investigator until resolution or until the 30-day follow-up visit when the patient exited the study. Collection of adverse events started after the time that the informed consent form was signed and the subject was enrolled. Adverse events were monitored throughout the study up until each patient's exit from the study.
Metabolism and nutrition disorders Adrenal insufficiency	2.0% 1/50 • Number of events 1 • All AEs were followed by the Investigator until resolution or until the 30-day follow-up visit when the patient exited the study. Collection of adverse events started after the time that the informed consent form was signed and the subject was enrolled. Adverse events were monitored throughout the study up until each patient's exit from the study.

Other adverse events

Other adverse events
Measure	All Subjects n=50 participants at risk All participants who were treated with the FlowTriever System and FlowTriever2 Catheter for mechanical thrombectomy of PE.
Vascular disorders Deep Vein Thrombosis	4.0% 2/50 • Number of events 2 • All AEs were followed by the Investigator until resolution or until the 30-day follow-up visit when the patient exited the study. Collection of adverse events started after the time that the informed consent form was signed and the subject was enrolled. Adverse events were monitored throughout the study up until each patient's exit from the study.
Vascular disorders Blood Loss Anaemia	2.0% 1/50 • Number of events 1 • All AEs were followed by the Investigator until resolution or until the 30-day follow-up visit when the patient exited the study. Collection of adverse events started after the time that the informed consent form was signed and the subject was enrolled. Adverse events were monitored throughout the study up until each patient's exit from the study.
Vascular disorders Hypertension	2.0% 1/50 • Number of events 1 • All AEs were followed by the Investigator until resolution or until the 30-day follow-up visit when the patient exited the study. Collection of adverse events started after the time that the informed consent form was signed and the subject was enrolled. Adverse events were monitored throughout the study up until each patient's exit from the study.
Vascular disorders Hypertensive emergency	2.0% 1/50 • Number of events 1 • All AEs were followed by the Investigator until resolution or until the 30-day follow-up visit when the patient exited the study. Collection of adverse events started after the time that the informed consent form was signed and the subject was enrolled. Adverse events were monitored throughout the study up until each patient's exit from the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	4.0% 2/50 • Number of events 2 • All AEs were followed by the Investigator until resolution or until the 30-day follow-up visit when the patient exited the study. Collection of adverse events started after the time that the informed consent form was signed and the subject was enrolled. Adverse events were monitored throughout the study up until each patient's exit from the study.
Respiratory, thoracic and mediastinal disorders COVID-19	2.0% 1/50 • Number of events 1 • All AEs were followed by the Investigator until resolution or until the 30-day follow-up visit when the patient exited the study. Collection of adverse events started after the time that the informed consent form was signed and the subject was enrolled. Adverse events were monitored throughout the study up until each patient's exit from the study.
Respiratory, thoracic and mediastinal disorders Haemoptysis	2.0% 1/50 • Number of events 1 • All AEs were followed by the Investigator until resolution or until the 30-day follow-up visit when the patient exited the study. Collection of adverse events started after the time that the informed consent form was signed and the subject was enrolled. Adverse events were monitored throughout the study up until each patient's exit from the study.
Musculoskeletal and connective tissue disorders Pain in extremity	4.0% 2/50 • Number of events 2 • All AEs were followed by the Investigator until resolution or until the 30-day follow-up visit when the patient exited the study. Collection of adverse events started after the time that the informed consent form was signed and the subject was enrolled. Adverse events were monitored throughout the study up until each patient's exit from the study.
Cardiac disorders Atrial fibrillation	2.0% 1/50 • Number of events 1 • All AEs were followed by the Investigator until resolution or until the 30-day follow-up visit when the patient exited the study. Collection of adverse events started after the time that the informed consent form was signed and the subject was enrolled. Adverse events were monitored throughout the study up until each patient's exit from the study.
Injury, poisoning and procedural complications Fall	2.0% 1/50 • Number of events 1 • All AEs were followed by the Investigator until resolution or until the 30-day follow-up visit when the patient exited the study. Collection of adverse events started after the time that the informed consent form was signed and the subject was enrolled. Adverse events were monitored throughout the study up until each patient's exit from the study.
Injury, poisoning and procedural complications Post procedural haemorrhage	2.0% 1/50 • Number of events 1 • All AEs were followed by the Investigator until resolution or until the 30-day follow-up visit when the patient exited the study. Collection of adverse events started after the time that the informed consent form was signed and the subject was enrolled. Adverse events were monitored throughout the study up until each patient's exit from the study.
Nervous system disorders Headache	2.0% 1/50 • Number of events 1 • All AEs were followed by the Investigator until resolution or until the 30-day follow-up visit when the patient exited the study. Collection of adverse events started after the time that the informed consent form was signed and the subject was enrolled. Adverse events were monitored throughout the study up until each patient's exit from the study.

Additional Information

Ashleigh Willson

Inari Medical

Phone: 925-330-3446

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place