Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy

Status: Recruiting
Location: See all (40) locations...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

PE-TRACT is an open-label, assessor-blinded, randomized trial, aiming to compare catheter-directed therapy (CDT) and anticoagulation (CDT group) with anticoagulation alone (No-CDT) in 500 patients with submassive PE, proximal pulmonary artery thrombus and right ventricular dilation.

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

• Symptomatic PE diagnosed by contrast-enhanced CT angiography with involvement of a main or lobar pulmonary artery branch; and

• Right ventricular (RV) dilation as defined by the presence of an RV/Left ventricular ratio \> 1 on CT angiography

Locations
United States
Alabama
The University of Alabama At Birmingham
RECRUITING
Birmingham
California
Stanford Medicine
RECRUITING
Palo Alto
UC Davis Health
RECRUITING
Sacramento
Scripps Memorial Hospital, La Jolla
RECRUITING
San Diego
The Lundquist Institute
RECRUITING
Torrance
Washington, D.c.
MedStar Health Research Institute
RECRUITING
Washington D.c.
Delaware
Christiana Care
RECRUITING
Newark
Florida
Baptist Health Miami Cardiac & Vascular Institute
RECRUITING
Miami
University of South Florida/ Tampa General Hospital
RECRUITING
Tampa
Georgia
Emory University School of Medicine
RECRUITING
Atlanta
Iowa
University of Iowa
RECRUITING
Iowa City
Illinois
University of Chicago Medical Center
RECRUITING
Chicago
Advocate Good Samaritan Hospital
RECRUITING
Downers Grove
Loyola University Chicago
RECRUITING
Maywood
Southern Illinois University School of Medicine
RECRUITING
Springfield
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Boston Medical Center
RECRUITING
Boston
Maine
MaineHealth
RECRUITING
Portland
Michigan
University of Michigan
RECRUITING
Ann Arbor
Trinity Health - Ann Arbor Hospital
RECRUITING
Ypsilanti
Missouri
Washington University in St. Louis
RECRUITING
St Louis
New Jersey
Rutgers New Jersey Medical School
RECRUITING
Newark
New Mexico
University of New Mexico Health Sciences Center
RECRUITING
Albuquerque
New York
Icahn School of Medicine at Mount Sinai
RECRUITING
New York
NYU Langone Health - Tisch Hospital
RECRUITING
New York
Weill Cornell Medicine
RECRUITING
New York
Ohio
Promedica
RECRUITING
Toledo
Oregon
Oregon Health & Science University
RECRUITING
Portland
Pennsylvania
Thomas Jefferson University
RECRUITING
Philadelphia
University of Pennsylvania
RECRUITING
Philadelphia
University of Pittsburgh Medical Center
RECRUITING
Pittsburgh
Main Line Healh
RECRUITING
Wynnewood
Rhode Island
Lifespan
RECRUITING
Providence
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Texas
The University of Texas Health Science Center at Houston
RECRUITING
Houston
Utah
Intermountain Health
RECRUITING
Murray
University of Utah Health
RECRUITING
Salt Lake City
Virginia
Sentara Health Research Center
RECRUITING
Norfolk
Carilion Clinic
RECRUITING
Roanoke
Wisconsin
Medical College of Wisconsin
RECRUITING
Milwaukee
Contact Information
Primary
Sunil Rao
Sunil.rao@nyulangone.org
212-263-0456
Backup
Stephanie Boumakis
stephanie.mavromichalis@nyulangone.org
212-263-0159
Time Frame
Start Date: 2023-07-17
Estimated Completion Date: 2027-06-26
Participants
Target number of participants: 500
Treatments
Experimental: Catheter-Directed Therapy (CDT) plus Anticoagulation
Participants will receive CDT consisting of mechanical thrombectomy (MT) or intrathrombus catheter-directed thrombolysis (CDL) using FDA-cleared devices for pulmonary embolism (PE). The exact technique and devices used will be at the discretion of the endovascular physician, within parameters defined by the PE-TRACT Manual of Operations (MOP) and accepted standard care. Before and after CDT, patients will receive standard PE therapy as in the no-CDT Arm.
Active_comparator: No Catheter-Directed Therapy (No-CDT)
Standard anticoagulant therapy (FDA-approved regimen) for the treatment of PE.
Related Therapeutic Areas
Sponsors
Leads: NYU Langone Health
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

This content was sourced from clinicaltrials.gov