Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy

Pulmonary Embolism Clinical Trial

— PE-TRACT  

Official title:

Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05591118
• Other study ID #: 22-01272
• Status: Recruiting
• Phase: Phase 3
• Start date: July 17, 2023
• Est. completion date: January 2028

Study information

• Verified date: May 2024
• Source: NYU Langone Health
• Contact: Akhilesh Sista
• Phone: 212-263-5898
• Email: aks9010[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: January 2028
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Intervention

Drug:
• Anticoagulant Therapy
All subjects will receive anticoagulation for a minimum of 3 months.

Device:
• Catheter-Directed Therapy
The endovascular physician can choose to use either mechanical thrombectomy (MT) using a device cleared by the FDA to treat PE or catheter-directed thrombolysis (CDL) using an infusion catheter cleared by the FDA to administer thrombolytic drugs for the treatment of PE

Locations

Country	Name	City	State
United States	University of New Mexico Health Sciences Center	Albuquerque	New Mexico
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University School of Medicine	Atlanta	Georgia
United States	The University of Alabama At Birmingham	Birmingham	Alabama
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Boston Medical Center	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Chicago Medical Center	Chicago	Illinois
United States	Advocate Good Samaritan Hospital	Downers Grove	Illinois
United States	The University of Texas Health Science Center at Houston	Houston	Texas
United States	University of Iowa	Iowa City	Iowa
United States	Loyola University Chicago	Maywood	Illinois
United States	Baptist Health Miami Cardiac & Vascular Institute	Miami	Florida
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Intermountain Health	Murray	Utah
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	NYU Langone Health - Tisch Hospital	New York	New York
United States	Weill Cornell Medicine	New York	New York
United States	Christiana Care	Newark	Delaware
United States	Rutgers New Jersey Medical School	Newark	New Jersey
United States	Sentara Health Research Center	Norfolk	Virginia
United States	Stanford Medicine	Palo Alto	California
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	MaineHealth	Portland	Maine
United States	Oregon Health & Science University	Portland	Oregon
United States	Lifespan	Providence	Rhode Island
United States	Carilion Clinic	Roanoke	Virginia
United States	UC Davis Health	Sacramento	California
United States	Washington University in St. Louis	Saint Louis	Missouri
United States	University of Utah Health	Salt Lake City	Utah
United States	Scripps Memorial Hospital, La Jolla	San Diego	California
United States	Southern Illinois University School of Medicine	Springfield	Illinois
United States	University of South Florida/ Tampa General Hospital	Tampa	Florida
United States	Promedica	Toledo	Ohio
United States	The Lundquist Institute	Torrance	California
United States	MedStar Health Research Institute	Washington	District of Columbia
United States	Main Line Healh	Wynnewood	Pennsylvania
United States	Trinity Health - Ann Arbor Hospital	Ypsilanti	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Oxygen Consumption (PVO2)	PVO2 measured during cardiopulmonary exercise test (CPET).	Month 3
Primary	New York Heart Association (NYHA) Functional Classification	The NYHA classifies the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity; the limitations/symptoms are in regards to normal breathing and varying degrees in shortness of breath and or angina pain: Class I - No symptoms and no limitation with ordinary physical activity.; Class II - Mild symptoms and slight limitation during ordinary activity.; Class III - Moderate limitation in activity (even less than ordinary) due to symptoms.; Class IV - Symptoms occur at rest and severe limitation with any physical activity.; Class V - Dead.	Month 12
Primary	Incidence of Major Bleeding at Day 7	International Society on Thrombosis and Haemostasis (ISTH) definition of "Major Bleeding" to be used. Per ISTH, Major Bleeding defined as: Fatal bleeding, AND/OR; Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, AND/OR; Bleeding causing a fall in hemoglobin level of 2 g/dL (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells.	Up to Day 7
Secondary	Six-Minute Walk Distance (6MWD)		Month 12
Secondary	Short-Form Health Survey-36 (SF-36) Score	36-item questionnaire assessing general health. It measures 8 dimensions of health status: social function, physical function, emotional role, physical role, mental health, vitality, physical pain, and general health. Scores range from 0 (worst health status) to 100 (best health status).	Month 12
Secondary	Incidence of Clinical Deterioration (Fatal and Non-Fatal) at Day 7	Clinical deterioration defined as hemodynamic decompensation or respiratory decompensation requiring endotracheal intubation.	Up to Day 7