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

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ClinicalTrials.gov Identifier: NCT02758574
Recruitment Status : Active, not recruiting
First Posted : May 2, 2016
Last Update Posted : October 12, 2020
Sponsor:
Information provided by (Responsible Party):
Efthymios Avgerinos, MD, University of Pittsburgh

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).

Condition or disease Intervention/treatment Phase
Pulmonary Embolism Procedure: CDT without ultrasound acceleration Procedure: CDT with ultrasound acceleration Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Standard Catheter Directed Thrombolysis vs. Ultrasound Assisted Thrombolysis for Patients With Acute Submassive Pulmonary Embolism
Study Start Date : May 2016
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: CDT without ultrasound acceleration
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
Procedure: CDT without ultrasound acceleration
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.
Other Name: Standard CDT

Experimental: CDT ultrasound accelerated
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
Procedure: CDT with ultrasound acceleration
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.
Other Name: Ultrasound assisted CDT




Primary Outcome Measures :
  1. PE thrombus load reduction (CT obstruction index) from baseline to the termination of lysis [ Time Frame: 48 hours ]

Secondary Outcome Measures :
  1. Mortality [ Time Frame: 90 days ]
  2. Stroke [ Time Frame: 30 days ]
    Any ischemic or hemorrhagic stroke

  3. Major Bleeding [ Time Frame: 30 days ]
    Any major bleeding event defined as hemorrhagic stroke, need to transfuse or need to intervene

  4. Echocardiographic Right Ventricular/Left Ventricular Diameter (ratio) [ Time Frame: 12 months ]
  5. Functional status (6 min walk test) [ Time Frame: 12 months ]
    6 min walk test (meters)

  6. Cost effectiveness analysis [ Time Frame: 12 months ]
    Quality Adjusted Life Years - Costs based on in-hospital resource utilization and out-of hospital care and follow-up.

  7. Echocardiographic Tricuspid Annular Plane Systolic Excursion (cm) [ Time Frame: 12 months ]
  8. Quality of life Questionnaire SF36 (score) [ Time Frame: 12 months ]
  9. Quality of life Questionnaire PE QOL (score) [ Time Frame: 12 months ]
  10. Quality of life Questionnaire San Diego Shortness of Breath (score) [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02758574


Locations
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United States, Pennsylvania
UPMC Presbyterian
Pittsburgh, Pennsylvania, United States, 15213
UPMC Mercy
Pittsburgh, Pennsylvania, United States, 15219
UPMC Shadyside
Pittsburgh, Pennsylvania, United States, 15232
UPMC Passavant
Pittsburgh, Pennsylvania, United States, 15237
Sponsors and Collaborators
University of Pittsburgh
Investigators
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Principal Investigator: Efthymios Avgerinos, M.D. University of Pittsburgh
Publications:
Jaff MR, McMurtry MS, Archer SL, Cushman M, Goldenberg N, Goldhaber SZ, Jenkins JS, Kline JA, Michaels AD, Thistlethwaite P, Vedantham S, White RJ, Zierler BK; American Heart Association Council on Cardiopulmonary, Critical Care, Perioperative and Resuscitation; American Heart Association Council on Peripheral Vascular Disease; American Heart Association Council on Arteriosclerosis, Thrombosis and Vascular Biology. Management of massive and submassive pulmonary embolism, iliofemoral deep vein thrombosis, and chronic thromboembolic pulmonary hypertension: a scientific statement from the American Heart Association. Circulation. 2011 Apr 26;123(16):1788-830. doi: 10.1161/CIR.0b013e318214914f. Epub 2011 Mar 21. Erratum in: Circulation. 2012 Aug 14;126(7):e104. Circulation. 2012 Mar 20;125(11):e495.
Piazza G ET, Sterling KM, et al. A prospective, single-arm, multicenter trial of the ekosonic endovascular system with activase for acute pulmonary embolism (seattle II). American College of Cardiology 63rd Annual Scientific Meeting. 2014

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Efthymios Avgerinos, MD, Assistant Professor of Surgery, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02758574    
Other Study ID Numbers: PRO15090058
First Posted: May 2, 2016    Key Record Dates
Last Update Posted: October 12, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Efthymios Avgerinos, MD, University of Pittsburgh:
acute pulmonary embolism
submassive pulmonary embolism
thrombolysis
catheter directed thrombolysis
ultrasound assisted thrombolysis
Additional relevant MeSH terms:
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Pulmonary Embolism
Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases