PEERLESS II: RCT of FlowTriever vs. Anticoagulation Alone in Pulmonary Embolism

Status: Recruiting
Location: See all (83) locations...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study is a prospective, multicenter, randomized controlled trial of the FlowTriever System plus anticoagulation compared to anticoagulation alone for intermediate-risk acute PE.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age at enrollment ≥ 18 years

• Objective evidence of a proximal filling defect in at least one main or lobar pulmonary artery, as confirmed by CTPA, pulmonary angiography, or other imaging modality

• RV dysfunction, as defined as one or more of the following: RV/LV ratio ≥ 0.9 or RV dilation or hypokinesis

• At least two additional risk factors, identified by at least one measure in two separate categories noted below:

• a. Hemodynamic: i. SBP 90-100mmHg ii. Resting heart rate \> 100 bpm b. Biomarker: i. Elevated\* cardiac troponin (troponin I or troponin T, conventional or high sensitivity) ii. Elevated\* BNP or NT-proBNP iii. Elevated venous lactate ≥2 mmol/L \* Elevated, meaning at or above the upper limit of normal, per local standards for the assay used c. Respiratory: i. O2 saturation \< 90% on room air ii. Supplemental O2 requirement ≥ 4 L/min iii. Respiratory rate ≥ 20 breaths/min iv. mMRC score \> 0

• Symptom onset within 14 days of confirmed PE diagnosis

• Willing and able to provide informed consent

Locations
United States
Alabama
Brookwood Medical Center
ACTIVE_NOT_RECRUITING
Birmingham
UAB Division of Cardiovascular Disease
RECRUITING
Birmingham
California
Huntington Memorial Hospital
RECRUITING
Pasadena
Colorado
University of Colorado, Denver
RECRUITING
Aurora
Connecticut
Yale University
RECRUITING
New Haven
Florida
HCA FL Largo Medical Center
RECRUITING
Largo
AdventHealth Orlando
RECRUITING
Orlando
Georgia
Emory University
RECRUITING
Atlanta
Illinois
Northwestern University
RECRUITING
Chicago
Kentucky
Baptist Health Louisville
WITHDRAWN
Louisville
Michigan
McLaren Greater Lansing
RECRUITING
Lansing
Minnesota
Metropolitan Heart & Vascular Institute
WITHDRAWN
Coon Rapids
Mayo Clinic
WITHDRAWN
Rochester
Missouri
Saint Luke's Hospital of Kansas City
RECRUITING
Kansas City
Mercy Hospital Springfield
RECRUITING
Springfield
Nebraska
Nebraska Medical Center
RECRUITING
Omaha
New Jersey
Virtua Health
RECRUITING
Camden
Valley Health
WITHDRAWN
Ridgewood
New York
SUNY, The University of Buffalo/Gates Vascular
RECRUITING
Buffalo
Northwell Health
RECRUITING
New York
Jamaica Hospital
RECRUITING
Queens
University of Rochester Medical Center
RECRUITING
Rochester
Stony Brook University Hospital
RECRUITING
Stony Brook
Montefiore Medical Center
RECRUITING
The Bronx
Ohio
University of Cincinnati Medical Center
RECRUITING
Cincinnati
The Cleveland Clinic Foundation
RECRUITING
Cleveland
Ohio State University - Wexner Medical Center
RECRUITING
Columbus
Pennsylvania
St. Luke's University Hospital
RECRUITING
Bethlehem
AHN Saint Vincent Hospital
RECRUITING
Erie
UPMC Hamot
RECRUITING
Erie
UPMC Harrisburg
RECRUITING
Harrisburg
The University of Pennsylvania
RECRUITING
Philadelphia
Thomas Jefferson University
NOT_YET_RECRUITING
Philadelphia
Allegheny Health Network Research Institute
RECRUITING
Pittsburgh
UPMC Heart and Vascular Institute
RECRUITING
Pittsburgh
Wellspan York Hospital
RECRUITING
York
Tennessee
HCA Tristar
RECRUITING
Brentwood
UTMC Knoxville
RECRUITING
Knoxville
Ascension Saint Thomas Hospital
RECRUITING
Nashville
Texas
Parkland Hospital
RECRUITING
Dallas
Texas Health Harris Methodist Hospital
RECRUITING
Fort Worth
Methodist Main Hospital
RECRUITING
San Antonio
Baylor Scott & White - Temple
RECRUITING
Temple
Virginia
Inova Fairfax
RECRUITING
Falls Church
Sentara Vascular Specialists
NOT_YET_RECRUITING
Norfolk
Washington
University of Washington
NOT_YET_RECRUITING
Seattle
Providence Sacred Heart
WITHDRAWN
Spokane
Wisconsin
Aurora Saint Luke's Medical Center
RECRUITING
Milwaukee
West Virginia
Charleston Area Medical Center
RECRUITING
Charleston
West Virginia University Ruby Memorial Hospital
RECRUITING
Morgantown
Other Locations
Belgium
Onze Lieve Vrouwziekenhuis
RECRUITING
Aalst
Canada
Royal Columbian Hospital
RECRUITING
New Westminster
Surrey Memorial Hospital
RECRUITING
Surrey
Vancouver General Hospital
RECRUITING
Vancouver
Denmark
Aarhus University Hospital
RECRUITING
Aarhus
France
CHU Lille
RECRUITING
Lille
Hôpital Louis Pradel
RECRUITING
Lyon
AP-HM Hopital La Timone
RECRUITING
Marseille
Hôpital Nord Marseille
RECRUITING
Marseille
Germany
University Hospital Augsburg
RECRUITING
Augsburg
Universitäts-Herzzentrum Bad Krozingen
RECRUITING
Bad Krozingen
Charité Campus Virchow Clinic - Klinik fuer Radiologie
RECRUITING
Berlin
Unfall Krankenhaus Berlin
RECRUITING
Berlin
University Hospital Cologne
RECRUITING
Cologne
HerzZentrum Dresden Universitaetsklinik
RECRUITING
Dresden
Universitaetsklinikum Dὒsseldorf
RECRUITING
Düsseldorf
Elisabeth Hospital GmbH
RECRUITING
Essen
Universitaetsklinikum Essen
RECRUITING
Essen
CCB Frankfurt
RECRUITING
Frankfurt
Universitaetsklinikum Hamburg Eppendorf
RECRUITING
Hamburg
University Hospital - Heidelberg
RECRUITING
Heidelberg
Universitaetsklinikum Saarlandes Homburg
WITHDRAWN
Homburg
Westpfalz Klinikum
RECRUITING
Kaiserslautern
Klinikum rechts der Isar (TUM)
NOT_YET_RECRUITING
Munich
Ludwig Maximilians-University
RECRUITING
Munich
University Hospital Regensburg
RECRUITING
Regensburg
Helios Kliniken Schwerin
RECRUITING
Schwerin
Schwarzwald-Baar-Klinikum
RECRUITING
Villingen-schwenningen
Poland
John Paul II Hospital
NOT_YET_RECRUITING
Krakow
Spain
Hopital Clinico Universitario San Carlos
RECRUITING
Madrid
Switzerland
Universitaetsspital Basel
RECRUITING
Basel
Universitätsspital Bern
RECRUITING
Bern
Luzerner Kantonsspital
RECRUITING
Lucerne
Contact Information
Primary
Cassandra Gamble
cassandra.gamble@inarimedical.com
763-412-5503
Time Frame
Start Date: 2023-11-17
Estimated Completion Date: 2026-07
Participants
Target number of participants: 1200
Treatments
Active_comparator: FlowTriever
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
Active_comparator: Anticoagulation
Commercially available/market approved anticoagulation medication including but not limited to: Heparin Sodium, Coumadin, Rivaroxaban, Apixaban, etc.~Anticoagulants are a group of medications that decrease your blood's ability to clot.
Related Therapeutic Areas
Sponsors
Leads: Inari Medical

This content was sourced from clinicaltrials.gov