Pulmonary EmbolismPhase 3PE-TRACTNCT05591118
Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy
A Phase 3 study testing Anticoagulant Therapy and Catheter-Directed Therapy in people with Pulmonary Embolism, run by NYU Langone Health at 40 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- Anticoagulant Therapy and Catheter-Directed Therapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 40 sitesUnited States
- Study dates
- 17 Jul 2023to 4 Aug 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
- Chronic 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
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
United States40 sites
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87131
University of Michigan
Ann Arbor, Michigan, 48109
Emory University School of Medicine
Atlanta, Georgia, 30308
The University of Alabama At Birmingham
Birmingham, Alabama, 35233
Boston Medical Center
Boston, Massachusetts, 02118
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Chicago Medical Center
Chicago, Illinois, 60637
Advocate Good Samaritan Hospital
Downers Grove, Illinois, 60515
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
University of Iowa
Iowa City, Iowa, 52242
Loyola University Chicago
Maywood, Illinois, 60153
Baptist Health Miami Cardiac & Vascular Institute
Miami, Florida, 33176
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Intermountain Health
Murray, Utah, 84107
NYU Langone Health - Tisch Hospital
New York, New York, 10016
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Weill Cornell Medicine
New York, New York, 10065
Christiana Care
Newark, Delaware, 19718
Rutgers New Jersey Medical School
Newark, New Jersey, 07103
Sentara Health Research Center
Norfolk, Virginia, 23507
Stanford Medicine
Palo Alto, California, 94304
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
MaineHealth
Portland, Maine, 04102
Oregon Health & Science University
Portland, Oregon, 97239
Lifespan
Providence, Rhode Island, 02903
Carilion Clinic
Roanoke, Virginia, 24014
UC Davis Health
Sacramento, California, 95817
University of Utah Health
Salt Lake City, Utah, 84108
Scripps Memorial Hospital, La Jolla
San Diego, California, 92121
Southern Illinois University School of Medicine
Springfield, Illinois, 62781
Washington University in St. Louis
St Louis, Missouri, 63110
University of South Florida/ Tampa General Hospital
Tampa, Florida, 33606
Promedica
Toledo, Ohio, 43606
The Lundquist Institute
Torrance, California, 90502
MedStar Health Research Institute
Washington D.C., District of Columbia, 20010
Main Line Healh
Wynnewood, Pennsylvania, 19096
Trinity Health - Ann Arbor Hospital
Ypsilanti, Michigan, 48197
About this study
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.
- Conditions
- Pulmonary Embolism
- Being tested
- Anticoagulant Therapy, Catheter-Directed Therapy
- Keywords
- Catheter-Directed Therapy (CDT)
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anticoagulant TherapyDrug
All subjects will receive anticoagulation for a minimum of 3 months.
Catheter-Directed TherapyDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Catheter-Directed Therapy (CDT) plus Anticoagulation | Experimental | 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. Receives: Drug: Anticoagulant Therapy; Device: Catheter-Directed Therapy |
| No Catheter-Directed Therapy (No-CDT) | Active comparator | Standard anticoagulant therapy (FDA-approved regimen) for the treatment of PE. Receives: Drug: Anticoagulant Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Oxygen Consumption (PVO2)
PVO2 measured during cardiopulmonary exercise test (CPET).
Measured: 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.
Measured: 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.
Measured: Up to Day 7
Secondary outcomes (3)
Six-Minute Walk Distance (6MWD)
Measured: 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).
Measured: 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.
Measured: Up to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start17 Jul 2023
- Primary completion29 Mar 2027 (estimated)
- Study completion4 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Sunil Rao, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05591118
- Sponsor's protocol ID
- 22-01272
- Acronym
- PE-TRACT
- Status last verified
- May 2026
- First submitted
- 18 Oct 2022
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Publications
Sista AK, Troxel AB, Tarpey T, Parpia S, Goldhaber SZ, Stringer WW, Magnuson EA, Cohen DJ, Kahn SR, Rao SV, Morris TA, Goldfeld KS, Vedantham S. Rationale and design of the PE-TRACT trial: A multicenter randomized trial to evaluate catheter-directed therapy for the treatment of intermediate-risk pulmonary embolism. Am Heart J. 2025 Mar;281:112-122. doi: 10.1016/j.ahj.2024.11.016. Epub 2024 Dec 3.
PubMed 39638275
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy
- ClinicalTrials.gov ID
- NCT05591118
- Acronym / sponsor ID
- PE-TRACT / 22-01272
- Conditions
- Pulmonary Embolism
- Keywords
- Catheter-Directed Therapy (CDT)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- 29 Mar 2027 (estimated)
- Study completion
- 4 Aug 2027 (estimated)
- First posted
- 24 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Catheter-Directed Therapy (CDT) plus Anticoagulation | Experimental | Drug: Anticoagulant Therapy, Device: Catheter-Directed TherapyParticipants 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. |
| No Catheter-Directed Therapy (No-CDT) | Active comparator | Drug: Anticoagulant TherapyStandard anticoagulant therapy (FDA-approved regimen) for the treatment of PE. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anticoagulant TherapyAll subjects will receive anticoagulation for a minimum of 3 months. | Drug | Catheter-Directed Therapy (CDT) plus Anticoagulation, No Catheter-Directed Therapy (No-CDT) |
| Catheter-Directed TherapyThe 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 | Device | Catheter-Directed Therapy (CDT) plus Anticoagulation |
Primary outcome
Peak Oxygen Consumption (PVO2)
Time frame: Month 3
PVO2 measured during cardiopulmonary exercise test (CPET).
New York Heart Association (NYHA) Functional Classification
Time frame: Month 12
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
Time frame: Up to Day 7
International Society on Thrombosis and Haemostasis (ISTH) definition of "Major Bleeding" to be used. Per ISTH, Major Bleeding defined as: 1. Fatal bleeding, AND/OR; 2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, AND/OR; 3. 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.
3 secondary outcomes
Six-Minute Walk Distance (6MWD)
Time frame: Month 12
Short-Form Health Survey-36 (SF-36) Score
Time frame: Month 12
Incidence of Clinical Deterioration (Fatal and Non-Fatal) at Day 7
Time frame: Up to Day 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Derived from this study: PubMed 39638275Sista AK, Troxel AB, Tarpey T, Parpia S, Goldhaber SZ, Stringer WW, Magnuson EA, Cohen DJ, Kahn SR, Rao SV, Morris TA, Goldfeld KS, Vedantham S. Rationale and design of the PE-TRACT trial: A multicenter randomized trial to evaluate catheter-directed therapy for the treatment of intermediate-risk pulmonary embolism. Am Heart J. 2025 Mar;281:112-122. doi: 10.1016/j.ahj.2024.11.016. Epub 2024 Dec 3.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sunil Rao, MD principal investigator
NYU Langone Health
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Anticoagulant Therapy and Catheter-Directed Therapy in people with Pulmonary Embolism, run by NYU Langone Health at 40 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Oxygen Consumption (PVO2) (time frame: Month 3). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05591118, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.