Primary Objective

The primary endpoint is a composite clinical endpoint constructed as a win ratio, a hierarchy of the following, assessed at hospital discharge or at 7 days after the index procedure, whichever is sooner: 1. All-cause mortality, or 2. Intracranial hemorrhage (ICH), or 3. Major bleeding per ISTH definition4, or 4. Clinical deterioration defined by hemodynamic or respiratory worsening, and/or escalation to a bailout therapy, or 5. ICU admission and ICU length-of-stay during the index hospitalization and following the index procedure.

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This study is a prospective, multicenter, randomized controlled trial of the FlowTriever System compared to CDT for acute intermediate-high-risk PE, and includes a non-randomized cohort for subjects with an absolute contraindication to thrombolytics. The study will collect data on demographics, comorbidities, details from the PE diagnosis and treatment, and clinical outcomes through 30-day follow up.




Classification of intermediate-high-risk Pulmonary Embolism (PE)

1. Age ≥ 18 years 2. Echo, computed tomographic pulmonary angiography (CTPA), or pulmonary angiographic evidence of any proximal filling defect in at least one main or lobar pulmonary artery 3. Classification of intermediate-high-risk PE by ESC Guidelines 20191, including ALL of the following: a. Clinical signs and symptoms consistent with acute PE, or PESI class III-V, or sPESI ≥1 AND b. Hemodynamically stable AND c. RV dysfunction on echocardiography or CT AND d. Elevated cardiac troponin levels 4. Intervention planned to begin within 72 hours of the later of either a. Confirmed PE diagnosis OR b. If transferring from another hospital, arrival at the treating hospital 5. Symptom onset within 14 days of confirmed PE diagnosis

Type of Study





University of Colorado Hospital

Principal Investigator
Photograph of Jonathan Lindquist,  MD

Jonathan Lindquist, MD

Study ID

Protocol Number: 21-4920

More information available at NCT05111613

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