Clinical trial NCT05591118: Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy
Official title: Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Pulmonary Embolism
Keywords: Catheter-Directed Therapy (CDT)
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2022-10-24
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: Inclusion Criteria:

1. Symptomatic PE diagnosed by contrast-enhanced CT angiography with involvement of a main or lobar pulmonary artery branch; and
2. Right ventricular (RV) dilation as defined by the presence of an RV/Left ventricular ratio \> 1 on CT angiography

Exclusion Criteria:

1. Age \< 18 years
2. Systolic blood pressure \< 90 mmHg for \>15 consecutive minutes or \> 40 mmHg drop from baseline, or vasopressor requirement for blood pressure support (i.e., massive PE), occurring within 1 hour prior to eligibility assessment.
3. Symptom duration \> 14 days for the current PE episode
4. Irreversible INR \> 3
5. Irreversible Thrombocytopenia (Platelets \< 50,000/microliter)
6. Creatinine \> 2.0 mg/dl
7. Hemoglobin \< 7.0 g/dl
8. Pregnancy (positive urine or blood pregnancy test (a pregnancy test must be obtained within 7 days prior to randomization in people of childbearing potential))
9. Allergy or hypersensitivity to Recombinant Tissue Plasminogen Activator (rt-PA), or iodinated contrast, except for mild-moderate contrast allergies for which steroid pre-medication can be used
10. Life expectancy \< 1 year
11. Chronic inability to independently walk prior to the current PE episode (e.g. wheelchair dependent, walker or cane dependent, paraplegic, and/or bed-bound)
12. Allergy to heparin or history of Heparin-Induced Thrombocytopenia (HIT)
13. Unable or unwilling to provide informed consent
14. Major contraindication or unsuitability for all CDT methods available at the Clinical Center

Primary outcomes:
measure: Peak Oxygen Consumption (PVO2)
timeFrame: Month 3
measure: New York Heart Association (NYHA) Functional Classification
timeFrame: Month 12
measure: Incidence of Major Bleeding at Day 7
timeFrame: Up to Day 7
Secondary outcomes:
measure: Six-Minute Walk Distance (6MWD)
timeFrame: Month 12
measure: Short-Form Health Survey-36 (SF-36) Score
timeFrame: Month 12
measure: Incidence of Clinical Deterioration (Fatal and Non-Fatal) at Day 7
timeFrame: Up to Day 7
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama At Birmingham
state: Alabama
city: Palo Alto
country: United States
facility: Stanford Medicine
state: California
city: Sacramento
country: United States
facility: UC Davis Health
state: California
city: San Diego
country: United States
facility: Scripps Memorial Hospital, La Jolla
state: California
city: Torrance
country: United States
facility: The Lundquist Institute
state: California
city: Newark
country: United States
facility: Christiana Care
state: Delaware
city: Washington
country: United States
facility: MedStar Health Research Institute
state: District of Columbia
city: Miami
country: United States
facility: Baptist Health Miami Cardiac & Vascular Institute
state: Florida
city: Tampa
country: United States
facility: University of South Florida/ Tampa General Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Downers Grove
country: United States
facility: Advocate Good Samaritan Hospital
state: Illinois
city: Maywood
country: United States
facility: Loyola University Chicago
state: Illinois
city: Springfield
country: United States
facility: Southern Illinois University School of Medicine
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Portland
country: United States
facility: MaineHealth
state: Maine
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Ypsilanti
country: United States
facility: Trinity Health - Ann Arbor Hospital
state: Michigan
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Newark
country: United States
facility: Rutgers New Jersey Medical School
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico Health Sciences Center
state: New Mexico
city: New York
country: United States
facility: NYU Langone Health - Tisch Hospital
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
city: Toledo
country: United States
facility: Promedica
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Wynnewood
country: United States
facility: Main Line Healh
state: Pennsylvania
city: Providence
country: United States
facility: Lifespan
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: Murray
country: United States
facility: Intermountain Health
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah Health
state: Utah
city: Norfolk
country: United States
facility: Sentara Health Research Center
state: Virginia
city: Roanoke
country: United States
facility: Carilion Clinic
state: Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: NYU Langone Health
name: Sunil Rao, MD
role: PRINCIPAL_INVESTIGATOR
References: