Ventilation and Perfusion Scan in Pulmonary Embolism Following Catheter Directed Thrombectomy Versus Anticoagulation Alone

Phase

N/A

Condition

Thrombosis

Vascular Diseases

Scleroderma

Treatment

N/A

Clinical Study ID

NCT05133713

STUDY00000091

Ages > 18
All Genders

Study Summary

Clinical presentation of acute pulmonary embolism (PE) is complex and varied and not uncommonly involves respiratory failure with dyspnea or hypoxia. Patients with persisting signs of respiratory failure despite anticoagulation, may benefit from catheter directed thrombectomy. Additionally, patient who receive thrombectomy are likely to have a lower residual thrombus burden measurable by ventilation-perfusion (V/Q) scan, and thereby less likely to develop chronic sequela, including chronic thromboembolic pulmonary hypertension (CTEPH) and post PE syndrome.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Age >18 years
Clinical signs and symptoms consistent with acute PE
Echocardiogram, CT pulmonary angiogram (CTPA) or pulmonary angiographic evidence ofproximal filling defect in at least one main or lobar pulmonary artery
Scheduled for PE treatment with catheter directed therapy and systemic anticoagulationor anticoagulation alone per the investigator's discretion
Signs of respiratory failure including a. arterial blood saturation <90%, or b.partial arterial oxygen pressure <60 mmHg, or c. persistent tachypnea with respiratoryrates > 20/min

Exclusion

Exclusion Criteria:

Unable to be anticoagulated with heparin or alternative therapy
Diagnosis with a minor PE without signs of right ventricular (RV) dysfunction
Known sensitivity to radiographic contrast agents that, in the Investigator's opinion,cannot be adequately pre-treated
Imaging evidence or other evidence that suggests, in opinion of the Investigator, thepatient is not appropriate for mechanical thrombectomy intervention (e.g., inabilityto navigate to target location or predominately chronic clot)
Life expectancy <6 months, as determined by the Investigator

Study Design

April 01, 2022

January 01, 2024

Study Description

Acute pulmonary embolism (PE) is a common disease with variable presentation and clinical outcomes. Chronic sequelae including chronic thromboembolic pulmonary hypertension (CTEPH) and post-PE syndrome are common pathologies for patient who survive the already significant inpatient mortality, and have a significant impact on both quality of life and life expectancy. To date, the ELOPE trial is the only study to prospectively compare quality of life (QoL) and dyspnea measures and six-minute walk distance (6MWD) to cardiopulmonary exercise test, revealing worse post-PE syndrome in select populations, however this study is limited to a single arm that received anticoagulation alone. New catheter directed therapies, developed in response to such poor outcomes, provide treatment options for acute PE patients when first line therapies including anticoagulation are contraindicated or have failed.

Long term studies utilizing imaging have shown a majority of patients diagnosed with PE have residual pulmonary thrombi after 6 months, which is likely to be a large contributor to the development of CTEPH. Ventilation-perfusion (V/Q) scans remain the gold standard for detection of both acute and chronic pulmonary embolism and will serve as a primary outcome measure at 6 months post initial treatment. Clinical measures including 6MWD, QoL and dyspnea questionaries will be assessed prior to discharge, and at 1 and 6 months, in order to characterize the development of chronic symptomatology.

Connect with a study center

Banner University Medical Center
Tucson, Arizona 85721
United States
Active - Recruiting

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