Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy

This study is for people with pulmonary embolism (PE), which is a blood clot in the lungs. It's comparing two ways to treat PE: one group will receive standard blood thinners (anticoagulant therapy) only, and the other group will receive blood thinners plus a procedure called catheter-directed therapy (CDT). CDT involves using a catheter to either remove the clot mechanically (mechanical thrombectomy) or deliver clot-dissolving medicine directly to the clot (catheter-directed thrombolysis). The study wants to see if CDT improves how well your body uses oxygen and your physical ability, and if it increases the risk of major bleeding. You might be able to join if you are 18 or older, have symptomatic PE in a main or lobar artery, and your heart's right ventricle is enlarged. The study plans to enroll 500 participants, but its current status is unclear.

Study design
This is an open-label, assessor-blinded, randomized study comparing catheter-directed therapy plus anticoagulation to anticoagulation alone, involving 500 participants.
What's involved
You would receive anticoagulant therapy for at least 3 months. If assigned to the CDT group, you would also undergo a catheter-directed procedure.
Compensation
Not stated in the trial record.
Follow-up
Your oxygen consumption will be measured at 3 months, and your physical ability will be assessed at 12 months. Major bleeding will be tracked for up to 7 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05591118

Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy

Recruiting
PHASE3Ages 18+InterventionalTreatment
NYU Langone Health
~500 participants
Updated 2026-05-18 on ClinicalTrials.gov
What's tested:Anticoagulant TherapyCatheter-Directed Therapy

At a glance

Recruiting sites
40 of 40 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Peak Oxygen Consumption (PVO2)
Measured over Month 3
+2 more outcomes measured
Pulmonary Embolism

NCT05591118

Where you'd take part

This study runs at 40 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Advocate Good Samaritan Hospital

    Downers Grove, Illinoisstudy coordinator listed

    Recruiting

  • Baptist Health Miami Cardiac & Vascular Institute

    Miami, Floridastudy coordinator listed

    Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusettsstudy coordinator listed

    Recruiting

  • Boston Medical Center

    Boston, Massachusettsstudy coordinator listed

    Recruiting

  • Carilion Clinic

    Roanoke, Virginiastudy coordinator listed

    Recruiting

  • Christiana Care

    Newark, Delawarestudy coordinator listed

    Recruiting

  • Emory University School of Medicine

    Atlanta, Georgiastudy coordinator listed

    Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Sunil Rao, MD · PRINCIPAL_INVESTIGATOR · NYU Langone Health

Opens a ready-to-send draft in your own email app — review before sending.

  • Peak Oxygen Consumption (PVO2)Month 3

    PVO2 measured during cardiopulmonary exercise test (CPET).

  • New York Heart Association (NYHA) Functional ClassificationMonth 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 7Up 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.