Standard vs Ultrasound-assisted Catheter Thrombolysis for Submassive Pulmonary Embolism

NACompletedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

October 19, 2017

Primary Completion Date

December 8, 2020

Study Completion Date

December 8, 2020

Conditions
Cardiovascular Diseases
Interventions
DEVICE

Standard Catheter-Directed Thrombolysis

Catheter-directed thrombolysis requires placement of a multi-sidehole infusion catheter within the pulmonary arterial thrombus burden, under angiographic guidance. Thrombolytic medications are slowly infused through the catheter, which is left in place for the duration of the treatment. The treatment will be performed according to current standard of care and all technical considerations will be left to the discretion of the operator performing the procedure. All follow up is according to standard of care.

DEVICE

Ultrasound-Accelerated Thrombolysis

USAT is a modification of standard catheter-directed thrombolysis utilizing a proprietary system of local high frequency, low-power ultrasound to dissociate the fibrin matrix of the thrombus, allowing deeper penetration of lytic medication. The treatment will be performed according to current standard of care and all technical considerations will be left to the discretion of the operator performing the procedure. All follow up is according to standard of care.

Trial Locations (4)

30303

Grady Health System, Atlanta

30308

Emory University Hospital Midtown, Atlanta

30322

Emory Clinic, Atlanta

Emory University Hospital, Atlanta

All Listed Sponsors
lead

Emory University

OTHER

NCT03086317 - Standard vs Ultrasound-assisted Catheter Thrombolysis for Submassive Pulmonary Embolism | Biotech Hunter | Biotech Hunter