Standard vs Ultrasound-assisted Catheter Thrombolysis for Submassive Pulmonary Embolism
Sponsor
Emory University (Other)
Overall Status
Completed
CT.gov ID
NCT03086317
Collaborator
(none)
18
4
2
37.7
4.5
0.1
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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. Catheter-directed therapies, mainly standard catheter-directed thrombolysis (CDT) and ultrasound-accelerated thrombolysis (USAT), have been introduced as new, more effective, and safer treatment modalities. USAT is a modification of standard catheter thrombolysis, utilizing a system of local ultrasound to dissociate the fibrin matrix of the thrombus, allowing deeper penetration of lytics. However, there is limited data comparing the two treatments. More rapid clearance of pulmonary thrombus by USAT compared to standard CDT may prove to be more effective regarding clinical outcomes and cost (e.g. via reduced length of ICU and hospital stay). Alternatively, if thrombus clearance is similar, the cost of USAT may exceed the cost of CDT (equipment and disposables), without offering any potential advantage.
This controlled, randomized study seeks to determine if ultrasound acceleration adds any benefits in the outcomes and costs of catheter-directed thrombolysis for patients with acute submassive PE. The treatment with CDT or USAT are standard of care for submassive PE and participants will be randomized to receive one treatment or the other. Participants will have follow up visits at 3 months and 12 months post procedure. All the procedures, tests, and follow up visits are according to current standard of care.
Study Design
Study Type:
Interventional
Actual Enrollment
:
18 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants will be randomized to receive one of two treatments for acute, submassive pulmonary embolism.Participants will be randomized to receive one of two treatments for acute, submassive pulmonary embolism.
Masking:
Single (Outcomes Assessor)
Masking Description:
Pre- and post-treatment computed tomography angiography (CTA) will be compared by independent radiologists who are blinded to the type treatment received.
Pre- and post-treatment echocardiograms will be interpreted by independent cardiologists who are blinded to the type of treatment received.
Primary Purpose:
Treatment
Official Title:
USAT-CDT Trial: Standard vs Ultrasound-assisted Catheter Thrombolysis for Submassive Pulmonary Embolism
Actual Study Start Date
:
Oct 19, 2017
Actual Primary Completion Date
:
Dec 8, 2020
Actual Study Completion Date
:
Dec 8, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Standard Catheter-Directed Thrombolysis Participants randomized to this arm will receive standard catheter-directed thrombolysis, per standard of care, as treatment for acute submassive pulmonary embolism. |
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.
Other Names:
|
| Active Comparator: Ultrasound-Accelerated Thrombolysis Participants randomized to this arm will receive ultrasound-accelerated thrombolysis, per standard of care, as treatment for acute submassive pulmonary embolism. |
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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of Thrombus Obstruction [Baseline to end of lysis treatment (up to 72 hours)]
Computed tomography angiography (CTA) will be performed before and after treatment. An independent radiologist will quantify the degree of obstruction from the thrombus by determining the vascular obstruction index. For determining the CT obstruction index, the arterial tree of each lung will be considered to have 10 segmental arteries (three to the upper lobes, two to both the middle lobe and the lingula, and five to the lower lobes).
Secondary Outcome Measures
- In Hospital Mortality [Until hospital discharge (an average of 6 days)]
Mortality during hospitalization will be compared between the two study arms.
- 90-day Mortality [Until 90 days post procedure]
Mortality until 90 days post procedure will be compared between the two study arms.
- Cardiac Decompensation Due to Massive Pulmonary Embolism [Through follow up (12 months)]
Cardiac decompensation, defined as hypotension (<90 millimeters of mercury (mmHg)) and use of catecholamines, will be compared between the two study arms.
- Major Bleeding [Through follow up (12 months)]
Major bleeding is defined as overt bleeding associated with a hemoglobin level reduction of at least 2.0 grams per deciliter (g/dL), or with transfusion of two or more units of red blood cells, or involvement of a critical site (intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome).
- Minor Bleeding [Through follow up (12 months)]
Clinically overt bleeding not fulfilling the criteria of major bleeding is classified as a minor bleeding complication.
- Symptomatic Venous Thromboembolism (VTE) [Until 90 days post procedure]
Recurrent venous thromboembolism (VTE) will be diagnosed if symptoms or signs of deep vein thrombosis or acute pulmonary embolism (PE) are confirmed by an imaging test. There will be no routine surveillance for asymptomatic recurrent VTE.
- Clinical Success of Treatment [Until 90 days post procedure]
Treatment will be considered successful if pulmonary embolism related decompensation is prevented, without the participant experiencing a major adverse event or death.
- ICU Length of Stay [Until hospital discharge (an average of 6 days)]
The number of days participants were admitted to the ICU will be compared between study arms.
- Change in Right Ventricular/Left Ventricular (RV/LV) Diameter Ratio [Baseline, end of lysis treatment, Month 3, Month 12]
Under normal circumstances, the right ventricle appears smaller than the left ventricle when measured by an echocardiogram (RV/LV ratio<1). An increased RV/LV ratio may be a predictor of poor clinical outcomes following pulmonary embolism.
- Change in Tricuspid Annular Plane Systolic Excursion (TAPSE) [Baseline, end of lysis treatment, Month 3, Month 12]
Tricuspid annular plane systolic excursion (TAPSE) is an echocardiographic of measuring right ventricular function. TAPSE measurements can be categorized as normal (1.5-2.0cm), mildly abnormal (1.3-1.5cm), moderately abnormal (1.0-1.2cm) or severely abnormal (<1.0cm).
- Change in Right Ventricular Systolic Pressure (RVSP) [Baseline, end of lysis treatment, Month 3, Month 12]
Right ventricular systolic pressure (RVSP) measured by echocardiogram provides an estimate the pressure inside the artery supplying blood to the lungs. Dysfunction in the right ventricle is assessed to predict clinical outcomes following pulmonary embolism.
- Number of Participants Who Had a Decrease in New York Heart Association (NYHA) Functional Classification of Heart Failure From Class 4 to Class 2 [Month 3, Month 12]
New York Heart Association (NYHA) Functional Classification of heart failure classifies heart failure with a combination of two methods: patient symptoms and objective assessment by a healthcare provider. Patient symptoms are classified as I-IV, where I = "no limitation of physical activity" and IV = "unable to carry on any physical activity without discomfort". An objective assessment by a healthcare provider is classified as A through D where A = "objective evidence of cardiovascular disease" and D = "objective evidence of severe cardiovascular disease".
- Change in 6-minute Walk Test [Month 3, Month 12]
The 6-minute walk test (6MWT) measures the distance that can be quickly walked by the study participant in 6 minutes. A 30 meter long walking course is created using cones on a hard, flat surface and the participant will walk the course as many times as they can in 6 minutes while a study team member counts the number of laps completed. Specific test guidelines from the American Thoracic Society will be followed.
- Change in 36-Item, Short Form (SF-36) Score [Month 3, Month 12]
The SF-36 is a 36 item survey assessing the quality of life across the 8 domains of physical functioning, limitations due to physical health, limitations due to emotional health, energy, emotional well-being, social functioning, pain, and general health. Each item is scored between 0 and 100 where 0 represents the worst possible quality of life and 100 corresponds with a healthy state of being. The numbers analyzed below represent the average score obtained with 0 being the bottom 25% of the quality of life (score 0-25), 1 is 26-50, 2 is 51-75, and 4 is 76-100.
- Change in Quality of Life After Pulmonary Embolism (PEmb QoL) Score [Month 3, Month 12]
Quality of life after pulmonary embolism (PEmb QoL) questionnaire is a 40 item survey asking respondents about their lung symptoms after having a pulmonary embolism. Participants report on 6 dimensions which cover the frequency and intensity of lung symptoms, physical and social limitations due to symptoms, pain, and emotional distress following having a pulmonary embolism. Scoring the responses involves specific instructions to reverse the scores for several dimensions, resulting in a score between 0 and 100 where 0 corresponds with "no complaints" and 100 is "worst possible" outcome.
- Change in Shortness of Breath Questionnaire Score [Month 3, Month 12]
The University of California San Diego (UCSD) Medical Center Shortness of Breath Questionnaire is a 24 item survey asking respondents how much shortness of breath they experience doing particular activities. Breathlessness is rated on a scale of 0 (not at all breathless) to 5 (maximally breathless or unable to do an activity become of breathlessness). Total scores range from 0 to 120, with higher scores indicating increased shortness of breath.
- Cost Effectiveness Analysis [Month 12]
A Markov state-transition, cost effectiveness model will be created to simulate patient oriented outcomes assuming a societal perspective with a 12-month time horizon. All point estimates for model parameters will be determined from the prospectively collected data. Quality adjusted life years will be determined for each therapy based on survival, freedom from major adverse events, discharge status, functional status, and quality of life measures. Costs will be calculated for each therapy based on in-hospital resource utilization (i.e., length of stay in the ICU, operating room and procedure costs, and associated adverse event costs) and out-of-hospital costs (outpatient nursing care, loss of work, outpatient testing and follow-up).
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 <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
Exclusion Criteria:
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Grady Health System | Atlanta | Georgia | United States | 30303 |
| 2 | Emory University Hospital Midtown | Atlanta | Georgia | United States | 30308 |
| 3 | Emory Clinic | Atlanta | Georgia | United States | 30322 |
| 4 | Emory University Hospital | Atlanta | Georgia | United States | 30322 |
Sponsors and Collaborators
- Emory University
Investigators
- Principal Investigator: Wissam Jaber, MD, Emory University
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Wissam Jaber,
Associate Professor,
Emory University
ClinicalTrials.gov Identifier:
NCT03086317
Other Study ID Numbers:
- IRB00093040
First Posted:
Mar 22, 2017
Last Update Posted:
Mar 18, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by Wissam Jaber,
Associate Professor,
Emory University
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Participants were recruited from Grady Health System and Emory Healthcare System in Atlanta, Georgia, USA. Participant enrollment began October 19, 2017, and all follow-ups were completed by December 8, 2020. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Standard Catheter-Directed Thrombolysis | Ultrasound-Accelerated Thrombolysis |
|---|---|---|
| Arm/Group Description | Participants randomized to this arm will receive standard catheter-directed thrombolysis, per standard of care, as treatment for acute submassive pulmonary embolism. 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. | Participants randomized to this arm will receive ultrasound-accelerated thrombolysis, per standard of care, as treatment for acute submassive pulmonary embolism. 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. |
| Period Title: Overall Study | ||
| STARTED | 10 | 8 |
| COMPLETED | 10 | 8 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Standard Catheter-Directed Thrombolysis | Ultrasound-Accelerated Thrombolysis | Total |
|---|---|---|---|
| Arm/Group Description | Participants randomized to this arm will receive standard catheter-directed thrombolysis, per standard of care, as treatment for acute submassive pulmonary embolism. 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. | Participants randomized to this arm will receive ultrasound-accelerated thrombolysis, per standard of care, as treatment for acute submassive pulmonary embolism. 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. | Total of all reporting groups |
| Overall Participants | 10 | 8 | 18 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
55
(10)
|
43
(15)
|
50
(13)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
5
50%
|
7
87.5%
|
12
66.7%
|
| Male |
5
50%
|
1
12.5%
|
6
33.3%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
5
50%
|
6
75%
|
11
61.1%
|
| White |
4
40%
|
1
12.5%
|
5
27.8%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
1
10%
|
1
12.5%
|
2
11.1%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
10
100%
|
8
100%
|
18
100%
|
| Concomitant Deep Venous Thrombosis (Count of Participants) | |||
| Count of Participants [Participants] |
3
30%
|
5
62.5%
|
8
44.4%
|
| Mean Oxygen at Baseline (percentage of oxygen saturation) [Number] | |||
| Number [percentage of oxygen saturation] |
92
|
95
|
94
|
| Mean Heart Rate (HR) at baseline (beats per minute) [Number] | |||
| Number [beats per minute] |
98
|
106
|
102
|
Outcome Measures
| Title | Percentage of Thrombus Obstruction |
|---|---|
| Description | Computed tomography angiography (CTA) will be performed before and after treatment. An independent radiologist will quantify the degree of obstruction from the thrombus by determining the vascular obstruction index. For determining the CT obstruction index, the arterial tree of each lung will be considered to have 10 segmental arteries (three to the upper lobes, two to both the middle lobe and the lingula, and five to the lower lobes). |
| Time Frame | Baseline to end of lysis treatment (up to 72 hours) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Standard Catheter-Directed Thrombolysis | Ultrasound-Accelerated Thrombolysis |
|---|---|---|
| Arm/Group Description | Participants randomized to this arm will receive standard catheter-directed thrombolysis, per standard of care, as treatment for acute submassive pulmonary embolism. 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. | Participants randomized to this arm will receive ultrasound-accelerated thrombolysis, per standard of care, as treatment for acute submassive pulmonary embolism. 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. |
| Measure Participants | 10 | 8 |
| Baseline ratio |
33
(4)
|
31
(4)
|
| End of lysis treatment (up to 72 hrs) |
23
(7)
|
22
(7)
|
| Title | In Hospital Mortality |
|---|---|
| Description | Mortality during hospitalization will be compared between the two study arms. |
| Time Frame | Until hospital discharge (an average of 6 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Standard Catheter-Directed Thrombolysis | Ultrasound-Accelerated Thrombolysis |
|---|---|---|
| Arm/Group Description | Participants randomized to this arm will receive standard catheter-directed thrombolysis, per standard of care, as treatment for acute submassive pulmonary embolism. 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. | Participants randomized to this arm will receive ultrasound-accelerated thrombolysis, per standard of care, as treatment for acute submassive pulmonary embolism. 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. |
| Measure Participants | 10 | 8 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
| Title | 90-day Mortality |
|---|---|
| Description | Mortality until 90 days post procedure will be compared between the two study arms. |
| Time Frame | Until 90 days post procedure |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Standard Catheter-Directed Thrombolysis | Ultrasound-Accelerated Thrombolysis |
|---|---|---|
| Arm/Group Description | Participants randomized to this arm will receive standard catheter-directed thrombolysis, per standard of care, as treatment for acute submassive pulmonary embolism. 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. | Participants randomized to this arm will receive ultrasound-accelerated thrombolysis, per standard of care, as treatment for acute submassive pulmonary embolism. 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. |
| Measure Participants | 10 | 8 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
| Title | Cardiac Decompensation Due to Massive Pulmonary Embolism |
|---|---|
| Description | Cardiac decompensation, defined as hypotension (<90 millimeters of mercury (mmHg)) and use of catecholamines, will be compared between the two study arms. |
| Time Frame | Through follow up (12 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Standard Catheter-Directed Thrombolysis | Ultrasound-Accelerated Thrombolysis |
|---|---|---|
| Arm/Group Description | Participants randomized to this arm will receive standard catheter-directed thrombolysis, per standard of care, as treatment for acute submassive pulmonary embolism. 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. | Participants randomized to this arm will receive ultrasound-accelerated thrombolysis, per standard of care, as treatment for acute submassive pulmonary embolism. 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. |
| Measure Participants | 10 | 8 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
| Title | Major Bleeding |
|---|---|
| Description | Major bleeding is defined as overt bleeding associated with a hemoglobin level reduction of at least 2.0 grams per deciliter (g/dL), or with transfusion of two or more units of red blood cells, or involvement of a critical site (intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome). |
| Time Frame | Through follow up (12 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Standard Catheter-Directed Thrombolysis | Ultrasound-Accelerated Thrombolysis |
|---|---|---|
| Arm/Group Description | Participants randomized to this arm will receive standard catheter-directed thrombolysis, per standard of care, as treatment for acute submassive pulmonary embolism. 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. | Participants randomized to this arm will receive ultrasound-accelerated thrombolysis, per standard of care, as treatment for acute submassive pulmonary embolism. 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. |
| Measure Participants | 10 | 8 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
| Title | Minor Bleeding |
|---|---|
| Description | Clinically overt bleeding not fulfilling the criteria of major bleeding is classified as a minor bleeding complication. |
| Time Frame | Through follow up (12 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Standard Catheter-Directed Thrombolysis | Ultrasound-Accelerated Thrombolysis |
|---|---|---|
| Arm/Group Description | Participants randomized to this arm will receive standard catheter-directed thrombolysis, per standard of care, as treatment for acute submassive pulmonary embolism. 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. | Participants randomized to this arm will receive ultrasound-accelerated thrombolysis, per standard of care, as treatment for acute submassive pulmonary embolism. 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. |
| Measure Participants | 10 | 8 |
| Count of Participants [Participants] |
0
0%
|
1
12.5%
|
| Title | Symptomatic Venous Thromboembolism (VTE) |
|---|---|
| Description | Recurrent venous thromboembolism (VTE) will be diagnosed if symptoms or signs of deep vein thrombosis or acute pulmonary embolism (PE) are confirmed by an imaging test. There will be no routine surveillance for asymptomatic recurrent VTE. |
| Time Frame | Until 90 days post procedure |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Standard Catheter-Directed Thrombolysis | Ultrasound-Accelerated Thrombolysis |
|---|---|---|
| Arm/Group Description | Participants randomized to this arm will receive standard catheter-directed thrombolysis, per standard of care, as treatment for acute submassive pulmonary embolism. 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. | Participants randomized to this arm will receive ultrasound-accelerated thrombolysis, per standard of care, as treatment for acute submassive pulmonary embolism. 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. |
| Measure Participants | 10 | 8 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
| Title | Clinical Success of Treatment |
|---|---|
| Description | Treatment will be considered successful if pulmonary embolism related decompensation is prevented, without the participant experiencing a major adverse event or death. |
| Time Frame | Until 90 days post procedure |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Standard Catheter-Directed Thrombolysis | Ultrasound-Accelerated Thrombolysis |
|---|---|---|
| Arm/Group Description | Participants randomized to this arm will receive standard catheter-directed thrombolysis, per standard of care, as treatment for acute submassive pulmonary embolism. 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. | Participants randomized to this arm will receive ultrasound-accelerated thrombolysis, per standard of care, as treatment for acute submassive pulmonary embolism. 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. |
| Measure Participants | 10 | 8 |
| Count of Participants [Participants] |
10
100%
|
8
100%
|
| Title | ICU Length of Stay |
|---|---|
| Description | The number of days participants were admitted to the ICU will be compared between study arms. |
| Time Frame | Until hospital discharge (an average of 6 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Standard Catheter-Directed Thrombolysis | Ultrasound-Accelerated Thrombolysis |
|---|---|---|
| Arm/Group Description | Participants randomized to this arm will receive standard catheter-directed thrombolysis, per standard of care, as treatment for acute submassive pulmonary embolism. 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. | Participants randomized to this arm will receive ultrasound-accelerated thrombolysis, per standard of care, as treatment for acute submassive pulmonary embolism. 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. |
| Measure Participants | 10 | 8 |
| Median (Inter-Quartile Range) [Days] |
2
|
2
|
| Title | Change in Right Ventricular/Left Ventricular (RV/LV) Diameter Ratio |
|---|---|
| Description | Under normal circumstances, the right ventricle appears smaller than the left ventricle when measured by an echocardiogram (RV/LV ratio<1). An increased RV/LV ratio may be a predictor of poor clinical outcomes following pulmonary embolism. |
| Time Frame | Baseline, end of lysis treatment, Month 3, Month 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Endpoint results include only participants who showed up for the study visits. |
| Arm/Group Title | Standard Catheter-Directed Thrombolysis | Ultrasound-Accelerated Thrombolysis |
|---|---|---|
| Arm/Group Description | Participants randomized to this arm will receive standard catheter-directed thrombolysis, per standard of care, as treatment for acute submassive pulmonary embolism. 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. | Participants randomized to this arm will receive ultrasound-accelerated thrombolysis, per standard of care, as treatment for acute submassive pulmonary embolism. 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. |
| Measure Participants | 10 | 8 |
| Baseline (RV/LV) diameter ratio |
1.7
(0.4)
|
1.5
(0.3)
|
| End of Lysis Treatment (RV/LV) diameter ratio |
1.1
(0.2)
|
1.2
(0.2)
|
| Month 3 |
0.87
(0.3)
|
0.89
(0.2)
|
| Month 12 |
0.82
(0.2)
|
0.84
(0.2)
|
| Title | Change in Tricuspid Annular Plane Systolic Excursion (TAPSE) |
|---|---|
| Description | Tricuspid annular plane systolic excursion (TAPSE) is an echocardiographic of measuring right ventricular function. TAPSE measurements can be categorized as normal (1.5-2.0cm), mildly abnormal (1.3-1.5cm), moderately abnormal (1.0-1.2cm) or severely abnormal (<1.0cm). |
| Time Frame | Baseline, end of lysis treatment, Month 3, Month 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data was not collected |
| Arm/Group Title | Standard Catheter-Directed Thrombolysis | Ultrasound-Accelerated Thrombolysis |
|---|---|---|
| Arm/Group Description | Participants randomized to this arm will receive standard catheter-directed thrombolysis, per standard of care, as treatment for acute submassive pulmonary embolism. 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. | Participants randomized to this arm will receive ultrasound-accelerated thrombolysis, per standard of care, as treatment for acute submassive pulmonary embolism. 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. |
| Measure Participants | 0 | 0 |
| Title | Change in Right Ventricular Systolic Pressure (RVSP) |
|---|---|
| Description | Right ventricular systolic pressure (RVSP) measured by echocardiogram provides an estimate the pressure inside the artery supplying blood to the lungs. Dysfunction in the right ventricle is assessed to predict clinical outcomes following pulmonary embolism. |
| Time Frame | Baseline, end of lysis treatment, Month 3, Month 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Results reflect participants who completed study procedures during each study visit |
| Arm/Group Title | Standard Catheter-Directed Thrombolysis | Ultrasound-Accelerated Thrombolysis |
|---|---|---|
| Arm/Group Description | Participants randomized to this arm will receive standard catheter-directed thrombolysis, per standard of care, as treatment for acute submassive pulmonary embolism. 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. | Participants randomized to this arm will receive ultrasound-accelerated thrombolysis, per standard of care, as treatment for acute submassive pulmonary embolism. 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. |
| Measure Participants | 10 | 8 |
| Baseline |
55
(14)
|
50
(10)
|
| End of lysis Treatment |
42
(0)
|
38
(0)
|
| Month 3 |
36
(12)
|
37
(19)
|
| Month 12 |
32
(10)
|
34
(16)
|
| Title | Number of Participants Who Had a Decrease in New York Heart Association (NYHA) Functional Classification of Heart Failure From Class 4 to Class 2 |
|---|---|
| Description | New York Heart Association (NYHA) Functional Classification of heart failure classifies heart failure with a combination of two methods: patient symptoms and objective assessment by a healthcare provider. Patient symptoms are classified as I-IV, where I = "no limitation of physical activity" and IV = "unable to carry on any physical activity without discomfort". An objective assessment by a healthcare provider is classified as A through D where A = "objective evidence of cardiovascular disease" and D = "objective evidence of severe cardiovascular disease". |
| Time Frame | Month 3, Month 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants had a baseline NYHA Class 4 |
| Arm/Group Title | Standard Catheter-Directed Thrombolysis | Ultrasound-Accelerated Thrombolysis |
|---|---|---|
| Arm/Group Description | Participants randomized to this arm will receive standard catheter-directed thrombolysis, per standard of care, as treatment for acute submassive pulmonary embolism. 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. | Participants randomized to this arm will receive ultrasound-accelerated thrombolysis, per standard of care, as treatment for acute submassive pulmonary embolism. 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. |
| Measure Participants | 6 | 5 |
| Month 3- Number of participants with NYHA Class 2 |
2
20%
|
2
25%
|
| Title | Change in 6-minute Walk Test |
|---|---|
| Description | The 6-minute walk test (6MWT) measures the distance that can be quickly walked by the study participant in 6 minutes. A 30 meter long walking course is created using cones on a hard, flat surface and the participant will walk the course as many times as they can in 6 minutes while a study team member counts the number of laps completed. Specific test guidelines from the American Thoracic Society will be followed. |
| Time Frame | Month 3, Month 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Standard Catheter-Directed Thrombolysis | Ultrasound-Accelerated Thrombolysis |
|---|---|---|
| Arm/Group Description | Participants randomized to this arm will receive standard catheter-directed thrombolysis, per standard of care, as treatment for acute submassive pulmonary embolism. 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. | Participants randomized to this arm will receive ultrasound-accelerated thrombolysis, per standard of care, as treatment for acute submassive pulmonary embolism. 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. |
| Measure Participants | 7 | 2 |
| Month 3 |
360
(131)
|
330
(28)
|
| Month 12 |
336
(14)
|
387
(92)
|
| Title | Change in 36-Item, Short Form (SF-36) Score |
|---|---|
| Description | The SF-36 is a 36 item survey assessing the quality of life across the 8 domains of physical functioning, limitations due to physical health, limitations due to emotional health, energy, emotional well-being, social functioning, pain, and general health. Each item is scored between 0 and 100 where 0 represents the worst possible quality of life and 100 corresponds with a healthy state of being. The numbers analyzed below represent the average score obtained with 0 being the bottom 25% of the quality of life (score 0-25), 1 is 26-50, 2 is 51-75, and 4 is 76-100. |
| Time Frame | Month 3, Month 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Standard Catheter-Directed Thrombolysis | Ultrasound-Accelerated Thrombolysis |
|---|---|---|
| Arm/Group Description | Participants randomized to this arm will receive standard catheter-directed thrombolysis, per standard of care, as treatment for acute submassive pulmonary embolism. 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. | Participants randomized to this arm will receive ultrasound-accelerated thrombolysis, per standard of care, as treatment for acute submassive pulmonary embolism. 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. |
| Measure Participants | 7 | 5 |
| Month 3 |
3.1
(0.94)
|
3.17
(0.69)
|
| Month 12 |
3.43
(0.73)
|
3.6
(0.49)
|
| Title | Change in Quality of Life After Pulmonary Embolism (PEmb QoL) Score |
|---|---|
| Description | Quality of life after pulmonary embolism (PEmb QoL) questionnaire is a 40 item survey asking respondents about their lung symptoms after having a pulmonary embolism. Participants report on 6 dimensions which cover the frequency and intensity of lung symptoms, physical and social limitations due to symptoms, pain, and emotional distress following having a pulmonary embolism. Scoring the responses involves specific instructions to reverse the scores for several dimensions, resulting in a score between 0 and 100 where 0 corresponds with "no complaints" and 100 is "worst possible" outcome. |
| Time Frame | Month 3, Month 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data not collected |
| Arm/Group Title | Standard Catheter-Directed Thrombolysis | Ultrasound-Accelerated Thrombolysis |
|---|---|---|
| Arm/Group Description | Participants randomized to this arm will receive standard catheter-directed thrombolysis, per standard of care, as treatment for acute submassive pulmonary embolism. 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. | Participants randomized to this arm will receive ultrasound-accelerated thrombolysis, per standard of care, as treatment for acute submassive pulmonary embolism. 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. |
| Measure Participants | 0 | 0 |
| Title | Change in Shortness of Breath Questionnaire Score |
|---|---|
| Description | The University of California San Diego (UCSD) Medical Center Shortness of Breath Questionnaire is a 24 item survey asking respondents how much shortness of breath they experience doing particular activities. Breathlessness is rated on a scale of 0 (not at all breathless) to 5 (maximally breathless or unable to do an activity become of breathlessness). Total scores range from 0 to 120, with higher scores indicating increased shortness of breath. |
| Time Frame | Month 3, Month 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data was not collected |
| Arm/Group Title | Standard Catheter-Directed Thrombolysis | Ultrasound-Accelerated Thrombolysis |
|---|---|---|
| Arm/Group Description | Participants randomized to this arm will receive standard catheter-directed thrombolysis, per standard of care, as treatment for acute submassive pulmonary embolism. 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. | Participants randomized to this arm will receive ultrasound-accelerated thrombolysis, per standard of care, as treatment for acute submassive pulmonary embolism. 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. |
| Measure Participants | 0 | 0 |
| Title | Cost Effectiveness Analysis |
|---|---|
| Description | A Markov state-transition, cost effectiveness model will be created to simulate patient oriented outcomes assuming a societal perspective with a 12-month time horizon. All point estimates for model parameters will be determined from the prospectively collected data. Quality adjusted life years will be determined for each therapy based on survival, freedom from major adverse events, discharge status, functional status, and quality of life measures. Costs will be calculated for each therapy based on in-hospital resource utilization (i.e., length of stay in the ICU, operating room and procedure costs, and associated adverse event costs) and out-of-hospital costs (outpatient nursing care, loss of work, outpatient testing and follow-up). |
| Time Frame | Month 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data was not collected |
| Arm/Group Title | Standard Catheter-Directed Thrombolysis | Ultrasound-Accelerated Thrombolysis |
|---|---|---|
| Arm/Group Description | Participants randomized to this arm will receive standard catheter-directed thrombolysis, per standard of care, as treatment for acute submassive pulmonary embolism. 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. | Participants randomized to this arm will receive ultrasound-accelerated thrombolysis, per standard of care, as treatment for acute submassive pulmonary embolism. 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. |
| Measure Participants | 0 | 0 |
Adverse Events
| Time Frame | Adverse events were collected beginning after randomization up to 90 days after randomization. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Standard Catheter-Directed Thrombolysis | Ultrasound-Accelerated Thrombolysis | ||
| Arm/Group Description | Participants randomized to this arm will receive standard catheter-directed thrombolysis, per standard of care, as treatment for acute submassive pulmonary embolism. 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. | Participants randomized to this arm will receive ultrasound-accelerated thrombolysis, per standard of care, as treatment for acute submassive pulmonary embolism. 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. | ||
All Cause Mortality |
||||
| Standard Catheter-Directed Thrombolysis | Ultrasound-Accelerated Thrombolysis | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/10 (0%) | 0/8 (0%) | ||
Serious Adverse Events |
||||
| Standard Catheter-Directed Thrombolysis | Ultrasound-Accelerated Thrombolysis | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/10 (0%) | 0/8 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Standard Catheter-Directed Thrombolysis | Ultrasound-Accelerated Thrombolysis | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/10 (0%) | 0/8 (0%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Wissam Jaber, Assistant Professor |
|---|---|
| Organization | Emory University |
| Phone | 4046861000 |
| wissam.jaber@emory.edu |
Responsible Party:
Wissam Jaber,
Associate Professor,
Emory University
ClinicalTrials.gov Identifier:
NCT03086317
Other Study ID Numbers:
- IRB00093040
First Posted:
Mar 22, 2017
Last Update Posted:
Mar 18, 2022
Last Verified:
Mar 1, 2022