The PEERLESS Study

Status: Completed
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: f
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
Loma Linda
Providence St. Joseph Orange
Orange
Huntington Hospital
Pasadena
Colorado
University of Colorado Hospital
Aurora
Florida
Radiology and Imaging Associates
Lakeland
Baptist Health South Florida
Miami
Sarasota Memorial Hospital
Sarasota
Tallahassee Memorial Hospital
Tallahassee
University of South Florida Tampa General Hospital
Tampa
Georgia
Emory University
Atlanta
Illinois
Ascension Alexian Brothers Medical Center
Elk Grove Village
Advocate Christ Medical Center
Oak Lawn
Indiana
Ascension St. Vincent Hospital - Indianapolis
Indianapolis
Kentucky
Norton Heralthcare
Louisville
Massachusetts
Beth Israel Deaconess Medical Center
Boston
Brigham and Women&#39;s Hospital
Boston
Michigan
Ascension St. John Hospital
Detroit
Minnesota
CentraCare St. Cloud Hospital
St. Cloud
Missouri
Saint Luke's Hospital of Kansas City
Kansas City
Saint Louis University
Saint Louis
Mississippi
University of Mississippi Medical Center
Jackson
North Carolina
University of North Carolina Health
Chapel Hill
Novant Health New Hanover Regional Medical Center
Wilmington
New Jersey
Virtua Lourdes
Camden
Hackensack University Medical Center
Hackensack
New York
Northwell Health
Bay Shore
Gates Vascular Institute
Buffalo
NewYork-Presbyterian Columbia University Irving Medical Center
New York
University of Rochester Medical Center
Rochester
Ohio
Summa Akron City Hospital
Akron
Mercy Health West
Cincinnati
University Hospitals Cleveland Medical Center
Cleveland
OhioHealth Riverside Methodist Hospital
Columbus
Pennsylvania
St. Luke's University Hospital
Bethlehem
AHN Saint Vincent Hospital
Erie
UPMC Harrisburg
Harrisburg
Temple University Hospital
Philadelphia
Thomas Jefferson University Hospital
Philadelphia
University of Pennsylvania
Philadelphia
Allegheny General Hospital
Pittsburgh
UPMC Presbyterian
Pittsburgh
South Carolina
MUSC Health University Medical Center
Charleston
Spartanburg Regional Healthcare System
Spartanburg
Lexington Medical Center
West Columbia
Tennessee
Ascension Saint Thomas Hospital
Nashville
HCA TriStar Centennial Medical Center
Nashville
Vanderbilt University Medical Center
Nashville
Texas
HCA Medical City Heart and Spine
Dallas
Houston Methodist Hospital
Houston
Memorial Hermann Medical Center
Houston
Methodist Main Hospital
San Antonio
Virginia
Sentara Norfolk General Hospital
Norfolk
Washington
Providence Sacred Heart Medical Center
Spokane
Wisconsin
Ascension St. Elizabeth Hospital
Appleton
Gundersen Health System
La Crosse
Aurora St. Luke's Medical Center
Milwaukee
Other Locations
Germany
Universtitaetsklinikum Dusseldorf
Düsseldorf
Herzzentrum Leipzig
Leipzig
Marien Hospital Wesel GmbH
Wesel
Switzerland
Inselspital - Universitätsspital Bern
Bern
Time Frame
Start Date: 2022-02-14
Completion Date: 2024-04-11
Participants
Target number of participants: 692
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