Standard vs Ultrasound-assisted Catheter Thrombolysis for Submassive Pulmonary Embolism

Completed · Not applicable

Conditions studied: Cardiovascular Diseases

In brief

The study is an investigator-initiated trial comparing two different catheters (standard versus ultrasound assisted) for the treatment of acute high risk pulmonary embolism (blood clots in lung arteries with evidence or heart strain). Patients already planned for the procedure will be randomized to standard catheter-directed thrombolysis (CDT) or to ultrasound-assisted catheter thrombolysis (USAT). Both catheters are currently used routinely in practice for the treatment of pulmonary embolism, but it is not known if USAT is superior to standard CDT, the former being much more expensive and more commonly used. The purpose of the study is to learn about which catheter-directed therapy is more suitable for patients with pulmonary embolism (PE), who are candidates for both standard catheter directed therapy (CDT), and ultrasound-assisted catheter directed therapy (USAT), and to provide information regarding the cost effectiveness of the two different types of treatment. A total of 80 patients are planned to be recruited. All medication administration, procedures or in-hospital tests will be performed as routine clinical practice. The study will compare short term and long term outcomes: resolution of blood clots on CT scan, right ventricular size improvement, quality of life and symptoms at 3 and 12 months, and cost effectiveness.

Key facts

Study ID

NCT03086317

Run by

Emory University

People needed

18

Starts

2017-10-19

Expected to finish

2020-12-08

Last updated by the study team

2023-06-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients eligible for catheter directed thrombolysis per the study protocol for submassive pulmonary embolism (PE)
• CT or echocardiographic RV strain (defined as RV/LV ratio >1)
• without persisting hypotension <90mmHg or drop of systolic blood pressure by at least 40mm Hg for at least 15 minutes with signs of end-organ hypoperfusion (cold extremities or low urinary output <30 mL/h or mental confusion)
• without the need of catecholamine support
• without the need of cardiopulmonary resuscitation

You may not qualify if…

• Pregnancy
• Index PE symptom duration >14 days
• High bleeding risk (any prior intracranial hemorrhage, known structural intracranial cerebrovascular disease or neoplasm, ischemic stroke within 3 months, suspected aortic dissection, active bleeding or bleeding diathesis, recent spinal or cranial/brain surgery, recent closed-head or facial trauma with bony fracture or brain injury)
• Participation in any other investigational drug or device study
• Life expectancy <90 days
• Inability to comply with study assessments

Where it is running

• Grady Health System — Atlanta, Georgia, United States
• Emory University Hospital Midtown — Atlanta, Georgia, United States
• Emory Clinic — Atlanta, Georgia, United States
• Emory University Hospital — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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