Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy

Recruiting Phase 3 Interventional Study
Pulmonary Embolism
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
500 (estimated)
Sponsor
NYU Langone Health · Other
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About This Trial

PE-TRACT is an open-label, assessor-blinded, randomized trial, aiming to compare catheter-directed therapy (CDT) and anticoagulation (CDT group) with anticoagulation alone (No-CDT) in 500 patients with submassive PE, proximal pulmonary artery thrombus and right ventricular dilation.

Trial Locations
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Eligibility 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 \< 1…
Contacts

Sunil Rao

212-263-0456

Sunil.rao@nyulangone.org

CONTACT

Lei Lei

212-263-4189

Lei.lei@nyulangone.org

CONTACT