Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

ULTRAsound-assisted Catheter vs. STAndaRd Catheter Thrombolysis for Submassive Pulmonary Embolism (UltraStar sPE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03389971
Recruitment Status : Active, not recruiting
First Posted : January 4, 2018
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Piedmont Healthcare

Brief Summary:
Acute pulmonary embolism (PE) accounts for 5-10% of in-hospital deaths. Systemic anticoagulation (AC) is the standard of care and thrombolysis is recommended for those at a higher mortality risk. Catheter-directed therapies, mainly standard infusion catheter 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 lysis utilizing a system of local ultrasound to dissociate the fibrin matrix of the thrombus with simultaneous acoustic streaming of the thrombolytic agent, allowing more efficient thrombolysis. However, there is limited comparative effectiveness data against standard multi-side hole catheter infusion. More rapid clearance of pulmonary thrombus by USAT compared to standard CDT may prove to be clinically beneficial and cost effective. Alternatively, if thrombus clearance is similar, the cost of USAT may exceed the cost of CDT (equipment and disposables), without realization any advantage.

Condition or disease Intervention/treatment Phase
Submassive Pulmonary Embolism Procedure: catheter-directed thrombolysis Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ULTRAsound-assisted Catheter vs. STAndaRd Catheter Thrombolysis for Submassive Pulmonary Embolism
Actual Study Start Date : December 6, 2017
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : February 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: multi-sidehole catheter Procedure: catheter-directed thrombolysis
catheter-directed thrombolysis with commercially available multi-sidehole catheter or USAT catheter

Experimental: USAT catheter Procedure: catheter-directed thrombolysis
catheter-directed thrombolysis with commercially available multi-sidehole catheter or USAT catheter




Primary Outcome Measures :
  1. thrombus load reduction [ Time Frame: 12 months post surgery ]
    Determine differences in the percentage of thrombus load reduction from baseline to the termination of lysis between the two techniques


Secondary Outcome Measures :
  1. cardiopulmonary and clinical outcomes - echocardiographic [ Time Frame: 12 months post surgery ]
    Determine differences in cardiopulmonary echocardiographic parameters between the two techniques

  2. cardiopulmonary and clinical outcomes - hemodynamic [ Time Frame: 12 months post surgery ]
    Determine differences in cardiopulmonary hemodynamic parameters between the two techniques

  3. cardiopulmonary and clinical outcomes - respiratory [ Time Frame: 12 months post surgery ]
    Determine differences in cardiopulmonary respiratory parameters between the two techniques

  4. cardiopulmonary and clinical outcomes - decompensation [ Time Frame: 12 months post surgery ]
    Determine differences in decompensation clinical outcomes between the two techniques

  5. cardiopulmonary and clinical outcomes - mortality [ Time Frame: 12 months post surgery ]
    Determine differences in mortality clinical outcomes between the two techniques

  6. cardiopulmonary and clinical outcomes - complications [ Time Frame: 12 months post surgery ]
    Determine differences in clinical complications between the two techniques

  7. cardiopulmonary and clinical outcomes - ICU stay [ Time Frame: 12 months post surgery ]
    Determine differences in ICU length of stay between the two techniques

  8. San Diego Shortness of Breath questionnaire [ Time Frame: 12 months post surgery ]
    Determine differences in the impact of catheter directed interventions on functional capacity and health-related quality of life outcomes at 3 and 12 months using a 0 to 5 scale where zero is nota at all breathless and 5 is maximally breathless or too breathless to do the activity. Total scoring range from 0 to 120.

  9. SF36 [ Time Frame: 12 months post surgery ]
    Determine differences in the impact of catheter directed interventions on functional capacity and health-related quality of life outcomes at 3 and 12 months using the questionnaire noted in the title

  10. PE QOL [ Time Frame: 12 months post surgery ]
    Determine differences in the impact of catheter directed interventions on functional capacity and health-related quality of life outcomes at 3 and 12 months using the questionnaire noted in the title

  11. utilization cost [ Time Frame: 12 months post surgery ]
    Perform a cost utilization analysis for the two patient groups to compare differences in medical costs

  12. resource utilization [ Time Frame: 12 months post surgery ]
    Perform a resource utilization analysis, what services will be utilized by the patient



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with submassive PE (CT or echocardiographic RV strain (defined as RV/LV ratio >1) without persisting hypotension <90mmHg or drop of systolic blood pressure by at least 40mm Hg for at least 15 minutes with signs of end-organ hypoperfusion (cold extremities or low urinary output <30 mL/h or mental confusion) and without the need of catecholamine support or cardiopulmonary resuscitation)

Exclusion Criteria:

  • <18 or >80
  • pregnancy
  • index PE symptom duration >14 days
  • high bleeding risk (any prior intracranial hemorrhage, known structural intracranial cerebrovascular disease or neoplasm, ischemic stroke within 3 months, suspected aortic dissection, active bleeding or bleeding diathesis, recent spinal or cranial/brain surgery, recent closed-head or facial trauma with bony fracture or brain injury)
  • participation in any other investigational drug or device study
  • life expectancy <90 days
  • inability to comply with study assessments

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): NCT03389971


Locations
Layout table for location information
United States, Georgia
Piedmont Healthcare
Atlanta, Georgia, United States, 30309
Sponsors and Collaborators
Piedmont Healthcare
Investigators
Layout table for investigator information
Principal Investigator: Charles Ross, MD Piedmont Healthcare
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

Layout table for additonal information
Responsible Party: Piedmont Healthcare
ClinicalTrials.gov Identifier: NCT03389971    
Other Study ID Numbers: UltraStar sPE
First Posted: January 4, 2018    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pulmonary Embolism
Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases