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Standard vs. Ultrasound-assisted Catheter Thrombolysis for Submassive Pulmonary Embolism (SUNSET sPE)

Primary Purpose

Pulmonary Embolism

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CDT without ultrasound acceleration
CDT with ultrasound acceleration
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Active Comparator

Experimental

Arm Label

CDT without ultrasound acceleration

CDT ultrasound accelerated

Arm Description

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

Outcomes

Primary Outcome Measures

PE thrombus load reduction (CT obstruction index) from baseline to the termination of lysis

Secondary Outcome Measures

Mortality
Stroke
Any ischemic or hemorrhagic stroke
Major Bleeding
Any major bleeding event defined as hemorrhagic stroke, need to transfuse or need to intervene
Echocardiographic Right Ventricular/Left Ventricular Diameter (ratio)
Functional status (6 min walk test)
6 min walk test (meters)
Cost effectiveness analysis
Quality Adjusted Life Years - Costs based on in-hospital resource utilization and out-of hospital care and follow-up.
Echocardiographic Tricuspid Annular Plane Systolic Excursion (cm)
Quality of life Questionnaire SF36 (score)
Quality of life Questionnaire PE QOL (score)
Quality of life Questionnaire San Diego Shortness of Breath (score)

Full Information

First Posted
March 22, 2016
Last Updated
September 3, 2021
Sponsor
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT02758574
Brief Title
Standard vs. Ultrasound-assisted Catheter Thrombolysis for Submassive Pulmonary Embolism
Acronym
SUNSET sPE
Official Title
Comparison of Standard Catheter Directed Thrombolysis vs. Ultrasound Assisted Thrombolysis for Patients With Acute Submassive Pulmonary Embolism
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
August 2021 (Actual)
Study Completion Date
August 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study will compare standard catheter directed thrombolysis to ultrasound accelerated thrombolysis for the treatment of acute submassive pulmonary embolism (PE). The study population will include patients eligible for catheter directed thrombolysis (CDT) for submassive PE. Subjects will be randomized to, either, standard catheter-directed thrombolysis or ultrasound-accelerated thrombolysis (USAT).
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 States translates to 200,000 deaths per year.1 Recent registries and cohort studies suggest that approximately 10% of all patients with acute PE die during the first 1 to 3 months after diagnosis. Studies that have observed survivors for >3 months have reported an incidence of chronic thromboembolic pulmonary hypertension (CTEPH) 1-5% within 2-3 years after PE.6-10 It is an incapacitating long-term complication of thromboembolic disease with a negative impact on the patient's quality of life and prognosis. The management acute PE is mainly guided by the acuity and severity of clinical presentation. Initial systemic anticoagulation (AC) is the standard of care and treatment is escalated based on the clinical presentation and patient characteristics that may stratify them at a higher mortality risk. The goals of therapy are to primarily prevent mortality, and secondarily potentially prevent late onset chronic thromboembolic pulmonary hypertension (CTEPH) and improve quality of life. Massive PE is defined as PE associated with sustained hemodynamic instability, whereas submassive PE (sPE) is defined as PE without hemodynamic instability but with abnormal right ventricular (RV) function and/or evidence of myocardial necrosis. It is notable that there is ongoing interest to accurately risk stratify sPE to identify the patients who are at increased risk of decompensating and/or dying. Clinical scores, imaging tests and biomarkers are under investigation, yet an ideal prognostic tool is still pending. A novel cardiac biomarker, heart-type fatty acid-binding protein (h-FABP), is emerging as a significant predictor of mortality in patients with submassive PE. Systemic intravenous thrombolysis is universally recommended by all guideline bodies for massive pulmonary embolism, but remains controversial for submassive PE. In the most recent metaanalysis, the subgroup analysis of 8 submassive PE trials (1993-2014, n=1775) showed that thrombolytic therapy was associated with a mortality reduction (1.39% vs 2.92%) but with an increase in major bleeding (7.74% vs 2.25%). These results were mainly driven by the largest randomized trial (PEITHO, 1006 patients) which compared a single, weight-adapted i.v. bolus of tenecteplase with standard anticoagulation. The recent development of catheter-directed therapies such as catheter-directed thrombolysis (CDT), ultrasound-accelerated thrombolysis (USAT), and pharmacomechanical or aspiration thrombectomy has introduced more tools for the treatment of acute PE. Proponents of these techniques suggest that they may provide a similar therapeutic benefit as systemic thrombolysis, while decreasing the dose of thrombolytic required and potentially decreasing the risk of adverse bleeding events. Both the American Heart Association and more recently European Society of Cardiology have acknowledged CDT as a viable treatment alternative for high risk acute sPE (echocardiographic RV dysfunction and elevated cardiac biomarkers), if appropriate expertise is available and particularly when the bleeding risk is high. 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. USAT is a modification of this therapy 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. Several observational non-controlled series have demonstrated the efficacy of catheter-directed techniques in improving clinical and hemodynamic parameters and reducing clot burden while demonstrating a favorable safety profile. The ULTIMA trial was the first randomized controlled trial to include CDIs for sPE comparing standardized fixed-dose of USAT (10mg rtPA per lung over 15 hours) and AC to AC alone. In the USAT group, but not in the heparin group, the mean RV/LV ratio was significantly reduced at 24 hours, but became comparable between the two groups at 90 days. The RV systolic function was significantly improved in the USAT group vs. the heparin group at both 24 hours and 90 days. In both study groups minor bleeding complications were rare and there were no major bleeding complications. The SEATTLE II trial, a single-arm study evaluating the effectiveness of USAT, showed also an RV/LV ratio improvement at 48 hours. Limited data exists for comparing different catheter-directed therapies for acute PE. The majority of recent series for catheter-directed interventions utilize USAT exclusively; however there is limited comparative effectiveness data comparing this modality to standard multi-sidehole catheter infusion. Preliminary, non-controlled data are conflicting. One series by Lin and colleagues of 33 high-risk PE patients suggested benefit for USAT for angiographic clearance of thrombus burden with more bleeding events in the CDT group.31 Kuo and colleagues noted no difference in outcomes and treatment specifics between USAT and CDT in the recently published early results of a multicenter prospective registry. Our retrospective analysis of 63 patients suggests that there may be no difference between the two treatment modalities, demonstrating similar rates of outcomes such as survival, hemodynamic stabilization, and echocardiographic parameters in both groups with similar procedure length and lytic dose in the time-adjusted cohorts. Selection bias cannot be underestimated in all these studies. The expected benefit of USAT has been dependent on the device's ability to increase penetration of lytic into thrombus using high frequency, low power ultrasound, due to its reversible effects on fibrin dissociation. This benefit has been shown to result in faster thrombus clearance in selected vascular beds in some studies, such as the recently published DUET study comparing USAT and CDT in arterial occlusions. More rapid clearance of pulmonary thrombus by USAT compared to standard CDT may prove to be clinically and cost effective (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 (proprietary equipment and disposables), without offering any potential advantage. Evidence from the venous circulation, coming from the recent BERNUTIFUL trial demonstrated no difference in time to thrombus clearance in lower extremity deep venous thrombosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism
Keywords
acute pulmonary embolism, submassive pulmonary embolism, thrombolysis, catheter directed thrombolysis, ultrasound assisted thrombolysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CDT without ultrasound acceleration
Arm Type
Active Comparator
Arm Description
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
Arm Title
CDT ultrasound accelerated
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
CDT without ultrasound acceleration
Other Intervention Name(s)
Standard CDT
Intervention Description
A pulmonary arteriogram will be performed. Upon confirmation of the pulmonary embolus a standard infusion catheter will be placed within the clot. The catheter will be used for infusion of thrombolytics to treat/dissolve the pulmonary embolus.
Intervention Type
Procedure
Intervention Name(s)
CDT with ultrasound acceleration
Other Intervention Name(s)
Ultrasound assisted CDT
Intervention Description
A pulmonary arteriogram will be performed. Upon confirmation of the pulmonary embolus an infusion catheter that incorporates an ultrasound emitting wire will be placed within the clot. The catheter will be used for infusion of thrombolytics to treat/dissolve the pulmonary embolus. The wire will be connected to an ultrasound generating device.
Primary Outcome Measure Information:
Title
PE thrombus load reduction (CT obstruction index) from baseline to the termination of lysis
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Mortality
Time Frame
90 days
Title
Stroke
Description
Any ischemic or hemorrhagic stroke
Time Frame
30 days
Title
Major Bleeding
Description
Any major bleeding event defined as hemorrhagic stroke, need to transfuse or need to intervene
Time Frame
30 days
Title
Echocardiographic Right Ventricular/Left Ventricular Diameter (ratio)
Time Frame
12 months
Title
Functional status (6 min walk test)
Description
6 min walk test (meters)
Time Frame
12 months
Title
Cost effectiveness analysis
Description
Quality Adjusted Life Years - Costs based on in-hospital resource utilization and out-of hospital care and follow-up.
Time Frame
12 months
Title
Echocardiographic Tricuspid Annular Plane Systolic Excursion (cm)
Time Frame
12 months
Title
Quality of life Questionnaire SF36 (score)
Time Frame
12 months
Title
Quality of life Questionnaire PE QOL (score)
Time Frame
12 months
Title
Quality of life Questionnaire San Diego Shortness of Breath (score)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Efthymios Avgerinos, M.D.
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
UPMC Presbyterian
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
UPMC Mercy
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15219
Country
United States
Facility Name
UPMC Shadyside
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
UPMC Passavant
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15237
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Standard vs. Ultrasound-assisted Catheter Thrombolysis for Submassive Pulmonary Embolism

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