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Anticoagulant
Catheter-Directed Therapy for Pulmonary Embolism (PE-TRACT Trial)
Phase 3
Recruiting
Led By Akhilesh Sista, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Symptomatic PE diagnosed by contrast-enhanced CT angiography with involvement of a main or lobar pulmonary artery branch
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 12
Awards & highlights
PE-TRACT Trial Summary
This trial compares two treatments for submassive PE: catheter-directed therapy + anticoagulation and anticoagulation alone, in 500 patients.
Who is the study for?
This trial is for adults with a type of lung blockage called submassive pulmonary embolism, who have certain heart measurements on a CT scan. They must be able to walk independently before the current episode and not have severe kidney issues, allergies to specific clot-dissolving drugs or contrast agents, very low blood counts, or be pregnant.Check my eligibility
What is being tested?
The PE-TRACT study is testing if using catheter-directed therapy (CDT) along with standard blood thinners helps more than just blood thinners alone in patients with a serious lung blockage condition. Participants are randomly chosen to receive either both treatments or only the blood thinner.See study design
What are the potential side effects?
Possible side effects from catheter-directed therapy may include bleeding at the catheter site, infection risk, and damage to blood vessels. Blood thinners can cause bleeding problems and sometimes allergic reactions.
PE-TRACT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a blood clot in my lung confirmed by a CT scan.
PE-TRACT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Major Bleeding at Day 7
New York Heart Association (NYHA) Functional Classification
Peak Oxygen Consumption (PVO2)
Secondary outcome measures
Incidence of Clinical Deterioration (Fatal and Non-Fatal) at Day 7
Short-Form Health Survey-36 (SF-36) Score
Six-Minute Walk Distance (6MWD)
PE-TRACT Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Catheter-Directed Therapy (CDT) plus AnticoagulationExperimental Treatment2 Interventions
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.
Group II: No Catheter-Directed Therapy (No-CDT)Active Control1 Intervention
Standard anticoagulant therapy (FDA-approved regimen) for the treatment of PE.
Find a Location
Who is running the clinical trial?
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,840 Previous Clinical Trials
47,851,624 Total Patients Enrolled
19 Trials studying Pulmonary Embolism
149,255 Patients Enrolled for Pulmonary Embolism
NYU Langone HealthLead Sponsor
1,369 Previous Clinical Trials
840,098 Total Patients Enrolled
1 Trials studying Pulmonary Embolism
1,612 Patients Enrolled for Pulmonary Embolism
Akhilesh Sista, MDPrincipal InvestigatorWeill Cornell School of Medicine
1 Previous Clinical Trials
119 Total Patients Enrolled
1 Trials studying Pulmonary Embolism
119 Patients Enrolled for Pulmonary Embolism
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are pregnant, or could be pregnant, based on a recent test.I am not allergic to rt-PA or iodinated contrast, or I can take steroids for mild-moderate contrast allergies.Your blood clotting test shows a high level that cannot be reversed.My current symptoms have lasted more than 14 days.I cannot or do not want to give permission for treatment.I couldn't walk on my own before my current health issue.Your creatinine levels are higher than 2.0 mg/dl.I have a blood clot in my lung confirmed by a CT scan.My platelet count is below 50,000.I cannot undergo any standard clot-dissolving treatments due to health risks.You are not expected to live for more than a year.You are allergic to heparin or have had a condition called Heparin-Induced Thrombocytopenia (HIT) in the past.Your hemoglobin level is less than 7.0 grams per deciliter.I am under 18 years old.My blood pressure has been very low or dropped significantly recently.Your right ventricle is too big compared to your left ventricle, as seen on a CT scan.
Research Study Groups:
This trial has the following groups:- Group 1: Catheter-Directed Therapy (CDT) plus Anticoagulation
- Group 2: No Catheter-Directed Therapy (No-CDT)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the FDA's opinion on Catheter-Directed Therapy (CDT) in combination with Anticoagulation?
"CDT plus Anticoagulation has been trialled before and there is some evidence of its efficacy. Furthermore, it has received multiple rounds of safety testing, so it was given a score of 3."
Answered by AI
Are there any open slots left for patients in this clinical trial?
"This particular trial is not looking for new participants at the moment, which was last updated on October 18th, 2022. However, there are 80 other trials that are actively enrolling patients right now."
Answered by AI
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