Standard vs. Ultrasound-assisted Catheter Thrombolysis for Submassive Pulmonary Embolism (SUNSET sPE)
Pulmonary Embolism
About this trial
This is an interventional treatment trial for Pulmonary Embolism focused on measuring acute pulmonary embolism, submassive pulmonary embolism, thrombolysis, catheter directed thrombolysis, ultrasound assisted thrombolysis
Eligibility Criteria
Criteria: Inclusion Criteria:
- Subject is eligible for catheter directed thrombolysis per the study protocol for submassive 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) and without the need of catecholamine support or cardiopulmonary resuscitation).
Exclusion Criteria:
- pregnancy;
- index PE symptom duration >14 days;
- high bleeding rsk (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.
Sites / Locations
- UPMC Presbyterian
- UPMC Mercy
- UPMC Shadyside
- UPMC Passavant
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
CDT without ultrasound acceleration
CDT ultrasound accelerated
Standard Catheter-Directed Thrombolysis: Utilization of a standard infusion catheter, placed at the site of pulmonary thrombus. The catheter will be used for the delivery of thrombolytic medications to treat/dissolve pulmonary embolus
Ultrasound Accelerated Catheter-Directed Thrombolysis: Utilization of an infusion catheter that incorporates an ultrasound emitting wire both placed at the site of pulmonary thrombus. The catheter will be used for the delivery of thrombolytic medications with the ultrasound emitting wire activated to treat/dissolve pulmonary embolus