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Submassive and Massive Pulmonary Embolism Treatment With Ultrasound Accelerated Thrombolysis Therapy (SEATTLE II)

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ClinicalTrials.gov Identifier: NCT01513759
Recruitment Status : Completed
First Posted : January 20, 2012
Results First Posted : July 3, 2019
Last Update Posted : July 3, 2019
Sponsor:
Information provided by (Responsible Party):
EKOS Corporation

Tracking Information
First Submitted Date  ICMJE January 17, 2012
First Posted Date  ICMJE January 20, 2012
Results First Submitted Date  ICMJE June 10, 2019
Results First Posted Date  ICMJE July 3, 2019
Last Update Posted Date July 3, 2019
Actual Study Start Date  ICMJE June 7, 2012
Actual Primary Completion Date February 17, 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2019)
  • Change From Baseline in the Right Ventricle (RV) Diameter-to-Left Ventricle (LV) Diameter Ratio Within 48 +/- 6 Hours of Initiation of Therapy [ Time Frame: Baseline, within 48 +/- 6 hours of initiation of therapy ]
    Change from baseline in RV diameter/LV diameter ratio was determined by contrast-enhanced chest computed tomography (CT) within 48 +/- 6 hours after initiating ultrasound-accelerated catheter-directed fibrinolysis.
  • Number of Participants With Major Bleeding [ Time Frame: From start of study drug infusion up to 72 hours ]
    Bleeding adverse events were graded (severe or life-threatening, moderate or mild bleeding) according to the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) classification. The participant incidence of major bleeding events was defined as GUSTO moderate and severe events occurring within 72 hours after starting the ultrasound-accelerated catheter-directed fibrinolysis procedure. Mild: Does not meet criteria for moderate or severe; Moderate: Requires transfusion - No hemodynamic compromise; and Severe: Bleeding causes hemodynamic compromise and required intervention or intracranial hemorrhage. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Original Primary Outcome Measures  ICMJE
 (submitted: January 17, 2012)
  • RV to LV Diameter Ratio [ Time Frame: Baseline and 48 ± 6 hours after Baseline ]
    Determine whether treatment with ultrasound-accelerated catheter-directed fibrinolysis will decrease the ratio of RV to LV diameter within 48 ± 6 hours in patients with massive or submassive PE.
  • Major Bleeding [ Time Frame: Within 72 hours of treatment initiation ]
    Determine the frequency of major bleeding within 72 hours of initiation of the ultrasound-accelerated catheter-directed fibrinolysis procedure in patients with massive or submassive PE.
Change History Complete list of historical versions of study NCT01513759 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2019)
  • Change From Baseline in Pulmonary Artery Systolic Pressure at 48 Hours After Start of Therapy [ Time Frame: Baseline, Hour 48 after initiation of therapy ]
    Change in pulmonary artery systolic pressure was assessed by baseline right-heart catheterization compared with right-heart catheterization at the conclusion of ultrasound-accelerated catheter-directed fibrinolysis and estimated by post-procedure transthoracic echocardiography within 48 hours after initiating the procedure.
  • Percentage of Participants With Symptomatic Recurrent Pulmonary Embolism (PE) [ Time Frame: Baseline up to Day 30 ]
    Percentage of participants with symptomatic recurrent PE up to 30 days following the conclusion of the ultrasound-accelerated catheter-directed fibrinolysis procedure, were reported with a Wilson score 95% confidence interval. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
  • Number of Participants Who Died Due to Any Cause [ Time Frame: Baseline up to Day 30 ]
    Number of participants who died due to any cause for up to 30 days following the conclusion of the ultrasound-accelerated catheter-directed fibrinolysis procedure, were reported.
  • Number of Devices That Could Not be Successfully Used for Infusion [ Time Frame: Baseline up to Day 30 ]
    Technical complications associated with the use of the EkoSonic device was recorded during catheter placement in the pulmonary artery and during the infusion procedure.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Submassive and Massive Pulmonary Embolism Treatment With Ultrasound Accelerated Thrombolysis Therapy
Official Title  ICMJE A Prospective, Single-Arm, Multi-Center Trial of EkoSonic® Endovascular System and Activase for Treatment of Acute Pulmonary Embolism (PE)
Brief Summary The purpose of this study is to determine if the EKOS EkoSonic® Endovascular Device when used in conjunction with recombinant tissue plasminogen activator (t-PA) as a treatment for acute PE will decrease the ratio of right ventricle (RV) to left ventricle (LV) diameter within 48 =/- 6 hours in participants with massive or submassive PE.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pulmonary Embolism
  • Acute Pulmonary Embolism
  • Sub-massive Pulmonary Embolism
  • Massive Pulmonary Embolism
  • Pulmonary Thromboembolism
Intervention  ICMJE
  • Drug: recombinant tissue plasminogen activator
    Participants will receive 24 mg of r-tPA delivered via the EkoSonic Endovascular Device.
    Other Names:
    • r-tPA
    • t-PA
    • Alteplase
  • Device: EKOS EkoSonic Endovascular System
    24 mg of r-tPA will be delivered through the EkoSonic Endovascular System.
    Other Names:
    • EkoSonic Endovascular Device
    • EkoSonic
Study Arms  ICMJE Experimental: EkoSonic® Endovascular System
Participants will receive a total of 24 milligrams (mg) of recombinant t-PA infusion, at an infusion rate of 1 milligrams/hour (mg/hr) per device (2 mg/hour for bilateral PE) delivered through the EkoSonic® Endovascular System. This regimen allows for a recombinant t-PA infusion time of 24 hours for one catheter and 12 hours for two catheters, respectively.
Interventions:
  • Drug: recombinant tissue plasminogen activator
  • Device: EKOS EkoSonic Endovascular System
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 11, 2013)
150
Original Estimated Enrollment  ICMJE
 (submitted: January 17, 2012)
120
Actual Study Completion Date  ICMJE February 17, 2013
Actual Primary Completion Date February 17, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Computed tomography (CT) evidence of proximal PE (filling defect in at least one main or segmental pulmonary artery)
  • PE symptom duration less than or equal to (<=)14 days
  • Informed consent can be obtained from participant or Legally Authorized Representative (LAR)
  • Massive PE (syncope, systemic arterial hypotension, cardiogenic shock, or resuscitated cardiac arrest) or
  • Submassive PE (RV diameter-to-LV diameter greater than or equal to [>=] 0.9 on contrast-enhanced chest CT)

Exclusion Criteria:

  • Stroke or transient ischemic attack (TIA), head trauma, or other active intracranial or intraspinal disease within one year
  • Recent (within one month) or active bleeding from a major organ
  • Hematocrit less than (<) 30 percent (%)
  • Platelets < 100 thousand/microliter (mcL)
  • International Normalized Ratio (INR) greater than (>) 3
  • Activated partial thromboplastin time (aPTT) >50 seconds on no anticoagulants
  • Major surgery within seven days of screening for study enrollment
  • Serum creatinine >2 milligrams/deciliter (mg/dL)
  • Clinician deems high-risk for catastrophic bleeding
  • History of heparin-induced thrombocytopenia (HIT)
  • Pregnancy
  • Catheter-based pharmacomechanical treatment for pulmonary embolism within 3 days of study enrollment
  • Systolic blood pressure less than 80 mm Hg despite vasopressor or inotropic support
  • Cardiac arrest (including pulseless electrical activity and asystole) requiring active cardiopulmonary resuscitation (CPR)
  • Evidence of irreversible neurological compromise
  • Life expectancy <30 days
  • Use of thrombolytics or glycoprotein IIb/IIIa antagonists within 3 days prior to inclusion in the study
  • Previous enrollment in the SEATTLE study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01513759
Other Study ID Numbers  ICMJE EKOS 09
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party EKOS Corporation
Study Sponsor  ICMJE EKOS Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Narinder Bhalla, MD Baptist Health
Principal Investigator: William Kuo, MD Stanford Hospital and Clinics
Principal Investigator: Stephen K Liu, MD Memorial Medical Center - Modesto
Principal Investigator: Immad Sidiq, MD Hartford Hospital
Study Chair: Samuel Z Goldhaber, MD Brigham and Women's
Principal Investigator: Mark J Garcia, MD Christiana Hospital
Principal Investigator: Rohit Bhatheja, MD Florida Hospital
Principal Investigator: Robert Kennedy, MD Holmes Regional Medical Center
Principal Investigator: Fakhir Elmasri, MD Lakeland Regional Medical Center
Principal Investigator: Barry S Weinstock, MD Orlando Regional Medical Center
Principal Investigator: Juan Ayerdi, MD Medical Center of Central Georgia
Principal Investigator: Nilesh Goswami, MD Prairie Heart Institute - St.John's Hospital
Principal Investigator: Kannan Natarajan, MD St. Vincent's Hospital-Manhattan
Principal Investigator: Tod C Engelhardt, MD East Jefferson General Hospital
Principal Investigator: Mark Kumar, MD Overlook Medical Center
Principal Investigator: John Rundback, MD Holy Name Hospital
Principal Investigator: Jacob Cynamon, MD Montefiore Medical Center
Principal Investigator: Peter Soukas, MD The Miriam Hospital
Principal Investigator: Mohammad L Raja, MD Providence Memorial Hospital - Sierra Vista Hospital
Principal Investigator: Keith M Sterling, MD Inova Alexandria
Principal Investigator: John Gurley, MD University of Kentucky
Principal Investigator: Noah Jones, MD Mt. Carmel East
PRS Account EKOS Corporation
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP