Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy (PE-TRACT)

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.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Embolism
• Intervention / Treatment: Drug: Anticoagulant Therapy; Device: Catheter-Directed Therapy

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Akhilesh Sista; Phone Number: 212-263-5898; Email: aks9010@med.cornell.edu
• Study Contact Backup: Name: Sunil Rao; Phone Number: 212-263-0456; Email: Sunil.rao@nyulangone.org

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Not yet recruiting
      • Cedars-Sinai Medical Center
      • Principal Investigator: Suhail Dohad, MD
  • Delaware
    • Newark, Delaware, United States, 19713
      • Recruiting
      • Christiana Care Health System
      • Principal Investigator: George Kimbiris, MD
  • Florida
    • Miami, Florida, United States, 33143
      • Recruiting
      • Baptist Hospital of Miami
      • Principal Investigator: Ripal Gandhi, MD
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Emory University
      • Principal Investigator: Wissam Jabar, MD
  • Illinois
    • Downers Grove, Illinois, United States, 60515
      • Recruiting
      • Advocate Aurora Health
      • Principal Investigator: Mahesh Raju, MD
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Beth Israel Deaconess Medical Center
      • Principal Investigator: Brett Carroll, MD
    • Boston, Massachusetts, United States, 02118
      • Recruiting
      • Boston Medical Center
      • Principal Investigator: Ashvin Pande, MD
  • New York
    • New York, New York, United States, 10027
      • Not yet recruiting
      • Columbia University
      • Principal Investigator: Sanjum Sethi, MD
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Health - Tisch Hospital
      • Contact: Sunil Rao; Email: Sunil.rao@nyulangone.org
  • North Carolina
    • Greensboro, North Carolina, United States, 27403
      • Not yet recruiting
      • Cone Health
      • Principal Investigator: Ravi Agarwala, MD
  • Virginia
    • Roanoke, Virginia, United States, 24014
      • Recruiting
      • Carilion Clinic
      • Principal Investigator: Joseph Hughes, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Anticoagulant Therapy; All subjects will receive anticoagulation for a minimum of 3 months.; Other Names: Activase (alteplase); 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
Active Comparator: No Catheter-Directed Therapy (No-CDT); Standard anticoagulant therapy (FDA-approved regimen) for the treatment of PE.	Drug: Anticoagulant Therapy; All subjects will receive anticoagulation for a minimum of 3 months.; Other Names: Activase (alteplase)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Oxygen Consumption (PVO2)	PVO2 measured during cardiopulmonary exercise test (CPET).	Month 3
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Six-Minute Walk Distance (6MWD)		Month 12
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
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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Akhilesh Sista, MD, Weill Cornell School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: October 18, 2022
• First Submitted That Met QC Criteria: October 18, 2022
• First Posted (Actual): October 24, 2022

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Catheter-Directed Therapy (CDT)
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Pulmonary Embolism; Anticoagulants
• Other Study ID Numbers: 22-01272

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: aks9010@med.cornell.edu.The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to aks9010@med.cornell.edu. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes