The PEERLESS Study

Status: Recruiting
Location: See all (60) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

A prospective, multicenter, randomized controlled trial of the FlowTriever System compared to Catheter-Directed Thrombolysis (CDT) for use in the treatment of acute pulmonary embolism. The trial includes a non-randomized cohort of subjects with an absolute contraindication to thrombolysis.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Subjects must meet each of the following criteria to be included in the study:

• Age ≥ 18 years

• Echo, computed tomographic pulmonary angiography (CTPA), or pulmonary angiographic evidence of any proximal filling defect in at least one main or lobar pulmonary artery

• Including ALL of the following: Clinical signs and symptoms consistent with acute PE, or PESI class III-V, or sPESI ≥1; AND Hemodynamically stable AND; RV dysfunction on echocardiography or CT; AND Any one or more of the following present at the time of diagnosis: Elevated cardiac troponin levels; History of heart failure; History of chronic lung disease; Heart rate ≥110 beats per minute; SBP <100mmHg; Respiratory rate ≥30 breaths per minute; O2 saturation <90%; Syncope related to PE; Elevated Lactate

• Intervention planned to begin within 72 hours of the later of either: confirmed PE diagnosis; OR if transferring from another hospital, arrival at the treating hospital

• Symptom onset within 14 days of confirmed PE diagnosis

Locations
United States
California
Loma Linda University Health
Recruiting
Loma Linda
Providence St. Joseph Orange
Recruiting
Orange
Huntington Hospital
Recruiting
Pasadena
Colorado
University of Colorado Hospital
Recruiting
Aurora
Delaware
Novant Health New Hanover Regional Medical Center
Not yet recruiting
Wilmington
Florida
Radiology and Imaging Associates
Recruiting
Lakeland
Baptist Health South Florida
Recruiting
Miami
Sarasota Memorial Hospital
Recruiting
Sarasota
Tallahassee Memorial Hospital
Recruiting
Tallahassee
University of South Florida Tampa General Hospital
Recruiting
Tampa
Georgia
Emory University
Recruiting
Atlanta
Illinois
Ascension Alexian Brothers Medical Center
Recruiting
Elk Grove Village
Advocate Christ Medical Center
Recruiting
Oak Lawn
Indiana
Ascension St. Vincent Hospital - Indianapolis
Active, not recruiting
Indianapolis
Kentucky
Norton Heralthcare
Recruiting
Louisville
Massachusetts
Beth Israel Deaconess Medical Center
Recruiting
Boston
Brigham and Women's Hospital
Recruiting
Boston
Michigan
Ascension St. John Hospital
Recruiting
Detroit
Minnesota
CentraCare St. Cloud Hospital
Recruiting
Saint Cloud
Missouri
Saint Luke's Hospital of Kansas City
Recruiting
Kansas City
Saint Louis University
Recruiting
Saint Louis
Mississippi
University of Mississippi Medical Center
Recruiting
Jackson
North Carolina
University of North Carolina Health
Recruiting
Chapel Hill
New Jersey
Virtua Lourdes
Not yet recruiting
Camden
Hackensack University Medical Center
Recruiting
Hackensack
New York
Northwell Health
Recruiting
Bay Shore
Gates Vascular Institute
Recruiting
Buffalo
NewYork-Presbyterian Columbia University Irving Medical Center
Recruiting
New York
University of Rochester Medical Center
Not yet recruiting
Rochester
Ohio
Summa Akron City Hospital
Recruiting
Akron
Mercy Health West
Recruiting
Cincinnati
University Hospitals Cleveland Medical Center
Recruiting
Cleveland
OhioHealth Riverside Methodist Hospital
Recruiting
Columbus
Pennsylvania
St. Luke's University Hospital
Not yet recruiting
Bethlehem
AHN Saint Vincent Hospital
Recruiting
Erie
UPMC Harrisburg
Recruiting
Harrisburg
Temple University Hospital
Recruiting
Philadelphia
Thomas Jefferson University Hospital
Recruiting
Philadelphia
University of Pennsylvania
Recruiting
Philadelphia
Allegheny General Hospital
Recruiting
Pittsburgh
UPMC Presbyterian
Recruiting
Pittsburgh
South Carolina
MUSC Health University Medical Center
Not yet recruiting
Charleston
Spartanburg Regional Healthcare System
Recruiting
Spartanburg
Lexington Medical Center
Recruiting
West Columbia
Tennessee
Ascension Saint Thomas Hospital
Recruiting
Nashville
HCA TriStar Centennial Medical Center
Recruiting
Nashville
Vanderbilt University Medical Center
Not yet recruiting
Nashville
Texas
HCA Medical City Heart and Spine
Not yet recruiting
Dallas
Houston Methodist Hospital
Not yet recruiting
Houston
Memorial Hermann Medical Center
Recruiting
Houston
Methodist Main Hospital
Not yet recruiting
San Antonio
Virginia
Sentara Norfolk General Hospital
Recruiting
Norfolk
Washington
Providence Sacred Heart Medical Center
Recruiting
Spokane
Wisconsin
Ascension St. Elizabeth Hospital
Recruiting
Appleton
Gundersen Health System
Recruiting
La Crosse
Aurora St. Luke's Medical Center
Recruiting
Milwaukee
Other Locations
Germany
Universtitaetsklinikum Dusseldorf
Not yet recruiting
Düsseldorf
Herzzentrum Leipzig
Not yet recruiting
Leipzig
Marien Hospital Wesel GmbH
Recruiting
Wesel
Switzerland
Inselspital - Universitätsspital Bern
Recruiting
Bern
Contact Information
Primary
Scott Skorupa
scott.skorupa@inarimedical.com
651-492-2654
Time Frame
Start Date: February 14, 2022
Estimated Completion Date: March 31, 2024
Participants
Target number of participants: 550
Treatments
Active Comparator: Randomized Controlled Trial Cohort - FlowTriever Arm
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
Active Comparator: Randomized Controlled Trial Cohort - Catheter-Directed Thrombolysis Arm
Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system)
Other: Non-Randomized Absolute Contraindication to Thrombolytics Cohort
Mechanical thrombectomy for pulmonary embolism using the FlowTriever System.
Related Therapeutic Areas
Sponsors
Leads: Inari Medical

This content was sourced from clinicaltrials.gov

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