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

Primary Purpose

Pulmonary Embolism

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Anticoagulant Therapy
Catheter-Directed Therapy
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Embolism focused on measuring Catheter-Directed Therapy (CDT)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NYU Langone Health - Tisch HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Catheter-Directed Therapy (CDT) plus Anticoagulation

No Catheter-Directed Therapy (No-CDT)

Arm Description

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.

Standard anticoagulant therapy (FDA-approved regimen) for the treatment of PE.

Outcomes

Primary Outcome Measures

Peak Oxygen Consumption (PVO2)
PVO2 measured during cardiopulmonary exercise test (CPET).
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.
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.

Secondary Outcome Measures

Six-Minute Walk Distance (6MWD)
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).
Incidence of Clinical Deterioration (Fatal and Non-Fatal) at Day 7
Clinical deterioration defined as hemodynamic decompensation or respiratory decompensation requiring endotracheal intubation.

Full Information

First Posted
October 18, 2022
Last Updated
July 26, 2023
Sponsor
NYU Langone Health
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT05591118
Brief Title
Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy
Acronym
PE-TRACT
Official Title
Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 17, 2023 (Actual)
Primary Completion Date
January 2027 (Anticipated)
Study Completion Date
January 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism
Keywords
Catheter-Directed Therapy (CDT)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Catheter-Directed Therapy (CDT) plus Anticoagulation
Arm Type
Experimental
Arm Description
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.
Arm Title
No Catheter-Directed Therapy (No-CDT)
Arm Type
Active Comparator
Arm Description
Standard anticoagulant therapy (FDA-approved regimen) for the treatment of PE.
Intervention Type
Drug
Intervention Name(s)
Anticoagulant Therapy
Intervention Description
All subjects will receive anticoagulation for a minimum of 3 months.
Intervention Type
Device
Intervention Name(s)
Catheter-Directed Therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Peak Oxygen Consumption (PVO2)
Description
PVO2 measured during cardiopulmonary exercise test (CPET).
Time Frame
Month 3
Title
New York Heart Association (NYHA) Functional Classification
Description
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.
Time Frame
Month 12
Title
Incidence of Major Bleeding at Day 7
Description
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.
Time Frame
Up to Day 7
Secondary Outcome Measure Information:
Title
Six-Minute Walk Distance (6MWD)
Time Frame
Month 12
Title
Short-Form Health Survey-36 (SF-36) Score
Description
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).
Time Frame
Month 12
Title
Incidence of Clinical Deterioration (Fatal and Non-Fatal) at Day 7
Description
Clinical deterioration defined as hemodynamic decompensation or respiratory decompensation requiring endotracheal intubation.
Time Frame
Up to Day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Age < 18 years 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. Symptom duration > 14 days for the current PE episode Irreversible INR > 3 Irreversible Thrombocytopenia (Platelets < 50,000/microliter) Creatinine > 2.0 mg/dl Hemoglobin < 7.0 g/dl Pregnancy (positive urine or blood pregnancy test (a pregnancy test must be obtained within 7 days prior to randomization in people of childbearing potential)) 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 Life expectancy < 1 year Inability to independently walk prior to the current PE episode (e.g. wheelchair dependent, walker or cane dependent, paraplegic, and/or bed-bound) Allergy to heparin or history of Heparin-Induced Thrombocytopenia (HIT) Unable or unwilling to provide informed consent Major contraindication or unsuitability for all CDT methods available at the Clinical Center
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Akhilesh Sista
Phone
212-263-5898
Email
aks9010@med.cornell.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sunil Rao
Phone
212-263-0456
Email
Sunil.rao@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Akhilesh Sista, MD
Organizational Affiliation
Weill Cornell School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health - Tisch Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sunil Rao
Email
Sunil.rao@nyulangone.org

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy

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