Status:
COMPLETED
ULTRAsound-assisted Catheter vs. STAndaRd Catheter Thrombolysis for Submassive Pulmonary Embolism
Lead Sponsor:
Piedmont Healthcare
Conditions:
Submassive Pulmonary Embolism
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Acute pulmonary embolism (PE) accounts for 5-10% of in-hospital deaths. Systemic anticoagulation (AC) is the standard of care and thrombolysis is recommended for those at a higher mortality risk. Cath...
Detailed Description
Acute pulmonary embolism (PE) carries a high morbidity and is the third-leading cause of cardiovascular mortality in the western world. It accounts for 5-10% of in-hospital deaths that for the United ...
Eligibility Criteria
Inclusion
- Patients with 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
- \<18 or \>80
- 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
Key Trial Info
Start Date :
December 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2020
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03389971
Start Date
December 6 2017
End Date
April 1 2020
Last Update
September 24 2021
Active Locations (1)
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1
Piedmont Healthcare
Atlanta, Georgia, United States, 30309