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.
Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy
At a glance
Conditions
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.
Study leadership
- Sunil Rao, MD · PRINCIPAL_INVESTIGATOR · NYU Langone Health
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- 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.