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Removing blood clots in the lungs using catheter-directed therapy

Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy

Phase 3 Interventional NYU Langone Health · NCT05591118

This study is testing if a new treatment that uses a catheter to remove blood clots in the lungs can help people with pulmonary embolism feel better compared to just using blood thinners.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment500 (estimated)
Ages18 Years and up
SexAll
SponsorNYU Langone Health Academic / other
Locations40 sites (Birmingham, Alabama and 39 other locations)
Trial IDNCT05591118 on ClinicalTrials.gov

What this trial studies

This trial compares the effectiveness of catheter-directed therapy (CDT) combined with anticoagulation against anticoagulation alone in patients suffering from submassive pulmonary embolism (PE). It is an open-label, assessor-blinded, randomized study involving 500 participants who have been diagnosed with PE and exhibit right ventricular dilation. The aim is to determine if CDT can improve outcomes in this patient population compared to standard anticoagulation treatment.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with symptomatic submassive pulmonary embolism and right ventricular dilation.

Not a fit: Patients with severe hypotension, significant comorbidities, or those who have had symptoms for more than 14 days may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve recovery and reduce complications for patients with submassive pulmonary embolism.

How similar studies have performed: Previous studies have shown promise with catheter-directed therapies for pulmonary embolism, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Symptomatic PE diagnosed by contrast-enhanced CT angiography with involvement of a main or lobar pulmonary artery branch; and
2. Right ventricular (RV) dilation as defined by the presence of an RV/Left ventricular ratio \> 1 on CT angiography

Exclusion Criteria:

1. Age \< 18 years
2. 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.
3. Symptom duration \> 14 days for the current PE episode
4. Irreversible INR \> 3
5. Irreversible Thrombocytopenia (Platelets \< 50,000/microliter)
6. Creatinine \> 2.0 mg/dl
7. Hemoglobin \< 7.0 g/dl
8. Pregnancy (positive urine or blood pregnancy test (a pregnancy test must be obtained within 7 days prior to randomization in people of childbearing potential))
9. 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
10. Life expectancy \< 1 year
11. Chronic inability to independently walk prior to the current PE episode (e.g. wheelchair dependent, walker or cane dependent, paraplegic, and/or bed-bound)
12. Allergy to heparin or history of Heparin-Induced Thrombocytopenia (HIT)
13. Unable or unwilling to provide informed consent
14. Major contraindication or unsuitability for all CDT methods available at the Clinical Center

Where this trial is running

Birmingham, Alabama and 39 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Pulmonary EmbolismCatheter-Directed Therapy
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.