NCT02692586

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 26, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

April 29, 2021

Completed
Last Updated

May 24, 2021

Status Verified

April 1, 2021

Enrollment Period

1.6 years

First QC Date

February 23, 2016

Results QC Date

April 2, 2021

Last Update Submit

April 28, 2021

Conditions

Pulmonary EmbolismAcute Pulmonary EmbolismSubmassive Pulmonary EmbolismMassive Pulmonary Embolism

Keywords

ThromboembolismThrombectomyRight Heart StrainSubmassive PERight Ventricle DysfunctionMassive PE

Outcome Measures

Primary Outcomes (2)

  • Change in RV/LV Ratio

    Change in RV/LV ratio from baseline to 48 hours

    Baseline to 48 hours

  • Number of Participants With Major Adverse Events

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

    Within 48 hours

Study Arms (1)

FlowTriever System

EXPERIMENTAL
Device: FlowTriever System

Interventions

FlowTriever SystemDEVICE
FlowTriever System

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

East Alabama Heart & Vascular

Auburn, Alabama, United States

Location

St. Vincent's

Birmingham, Alabama, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, United States

Location

Florida Hospital

Orlando, Florida, United States

Location

Sacred Heart Hospital

Pensacola, Florida, United States

Location

Tampa General Hospital

Tampa, Florida, United States

Location

Emory University

Atlanta, Georgia, United States

Location

Ephraim McDowell Regional Medical Center

Danville, Kentucky, United States

Location

Baptist Health

Louisville, Kentucky, United States

Location

East Jefferson General Hospital

Metairie, Louisiana, United States

Location

North Shore University Hospital

Manhasset, New York, United States

Location

Ohio State University

Columbus, Ohio, United States

Location

OhioHealth Riverside Methodist Hospital

Columbus, Ohio, United States

Location

UPMC Hamot

Erie, Pennsylvania, United States

Location

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, United States

Location

UPMC

Pittsburgh, Pennsylvania, United States

Location

Houston Methodist Hospital

Houston, Texas, United States

Location

Charleston Area Medical Center

Charleston, West Virginia, United States

Location

MeSH Terms

Conditions

Pulmonary EmbolismThromboembolism

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Ashleigh Willson
Organization
Inari Medical
ashleigh.willson@inarimedical.com
877-923-4747

Study Officials

  • Kenneth Rosenfield, MD

    Massachusetts General Hospital

    STUDY CHAIR

  • Victor Tapson, MD

    Cedars-Sinai Medical Center

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2016

First Posted

February 26, 2016

Study Start

April 1, 2016

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

May 24, 2021

Results First Posted

April 29, 2021

Record last verified: 2021-04

Locations

US(18)