N/A
N=18
Standard vs Ultrasound-assisted Catheter Thrombolysis for Submassive Pulmonary Embolism
Cardiovascular Diseases
Bottom Line
View on ClinicalTrials.gov: NCT03086317 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcome: Primary: Percentage of Thrombus Obstruction — 33; 31; 23; 22 percentage of thrombus obstruction
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Standard Catheter-Directed Thrombolysis (Device); Ultrasound-Accelerated Thrombolysis (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Emory University
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Thrombus Obstruction |
33; 31; 23; 22 | — |
| SECONDARY In Hospital Mortality |
0; 0 | — |
| SECONDARY 90-day Mortality |
0; 0 | — |
| SECONDARY Cardiac Decompensation Due to Massive Pulmonary Embolism |
0; 0 | — |
| SECONDARY Major Bleeding |
0; 0 | — |
| SECONDARY Minor Bleeding |
0; 1 | — |
| SECONDARY Symptomatic Venous Thromboembolism (VTE) |
0; 0 | — |
| SECONDARY Clinical Success of Treatment |
10; 8 | — |
| SECONDARY ICU Length of Stay |
2; 2 | — |
| SECONDARY Change in Right Ventricular/Left Ventricular (RV/LV) Diameter Ratio |
1.7; 1.5; 1.1; 1.2; 0.87; 0.89 | — |
| SECONDARY Change in Tricuspid Annular Plane Systolic Excursion (TAPSE) |
— | — |
| SECONDARY Change in Right Ventricular Systolic Pressure (RVSP) |
55; 50; 42; 38; 36; 37 | — |
| SECONDARY Number of Participants Who Had a Decrease in New York Heart Association (NYHA) Functional Classification of Heart Failure From Class 4 to Class 2 |
2; 2 | — |
| SECONDARY Change in 6-minute Walk Test |
360; 330; 336; 387 | — |
| SECONDARY Change in 36-Item, Short Form (SF-36) Score |
3.1; 3.17; 3.43; 3.6 | — |
| SECONDARY Change in Quality of Life After Pulmonary Embolism (PEmb QoL) Score |
— | — |
| SECONDARY Change in Shortness of Breath Questionnaire Score |
— | — |
| SECONDARY Cost Effectiveness Analysis |
— | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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 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
Data sourced from ClinicalTrials.gov (NCT03086317). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.