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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

Must not have

Unable or unwilling to provide informed consent

Inability to independently walk prior to the current PE episode (e.g. wheelchair dependent, walker or cane dependent, paraplegic, and/or bed-bound)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 12

Awards & highlights

Pivotal Trial

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a blood clot in my lung confirmed by a CT scan.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot or do not want to give permission for treatment.

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I couldn't walk on my own before my current health issue.

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My platelet count is below 50,000.

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I cannot undergo any standard clot-dissolving treatments due to health risks.

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I am under 18 years old.

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My blood pressure has been very low or dropped significantly recently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Major Bleeding at Day 7

New York Heart Association (NYHA) Functional Classification

Peak Oxygen Consumption (PVO2)

Secondary study objectives

Incidence of Clinical Deterioration (Fatal and Non-Fatal) at Day 7

Short-Form Health Survey-36 (SF-36) Score

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 7Eligibility criteria met