Recruiting

Thrombectomy vs. Anticoagulation

Sponsor:

University of Arizona

Code:

NCT05133713

Conditions

Pulmonary Embolism

Pulmonary Hypertension

Chronic Thromboembolic Pulmonary Hypertension

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Catheter directed therapy

Systemic anticoagulation

Study Details

Brief 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.

Conditions

Pulmonary Embolism

Pulmonary Hypertension

Chronic Thromboembolic Pulmonary Hypertension

Study ID

NCT05133713

Start date

Apr 1, 2022

Status verified date

Sep, 2022

Completion date

Jan 1, 2024

Anticipated

Primary completion date

Dec 1, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Catheter directed thrombectomy

Systemic anticoagulation

Interventions

Catheter directed therapy

Thrombectomy

Systemic anticoagulation

Conservative therapy

Primary outcome measure

  • Ventilation-perfusion mismatch [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Locations

Banner University Medical Center

Recruiting

Tucson, Arizona, United States, 85721

More Information

Sponsor

University of Arizona

Last update posted

Sep 23, 2022

Last verified

Sep, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Arizona on 2022-09-23.