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A Prospective, Single-arm, Multi-center Trial of EkoSonic® Endovascular System and Activase for Treatment of Acute Pulmonary Embolism (PE). (SEATTLE II)

This study is currently recruiting participants.
Verified March 2013 by EKOS Corporation
Sponsor:
Information provided by (Responsible Party):
EKOS Corporation
ClinicalTrials.gov Identifier:
NCT01513759
First received: January 17, 2012
Last updated: March 25, 2013
Last verified: March 2013
History of Changes
  Purpose

The purpose of this study is to determine if the EKOS EkoSonic® Endovascular Device when used in conjunction with recombinant t-PA as a treatment for acute pulmonary embolism (PE) will decrease the ratio of RV to LV diameter within 48 ± 6 hours in patients with massive or submassive PE.


Condition Intervention Phase
Pulmonary Embolism
Acute Pulmonary Embolism
Sub-massive Pulmonary Embolism
Massive Pulmonary Embolism
Pulmonary Thromboembolism
 Drug: recombinant tissue plasminogen activator
Device: EKOS EkoSonic Endovascular System
Drug: Alteplase
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Submassive and Massive Pulmonary Embolism Treatment With Ultrasound Accelerated Thrombolysis Therapy

Resource links provided by NLM:

Drug Information available for: Alteplase
U.S. FDA Resources

Further study details as provided by EKOS Corporation:

Primary Outcome Measures:
  • RV to LV Diameter Ratio [ Time Frame: Baseline and 48 ± 6 hours after Baseline ] [ Designated as safety issue: No ]
    Determine whether treatment with ultrasound-accelerated catheter-directed fibrinolysis will significantly 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 ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 120
Study Start Date: May 2012
Estimated Study Completion Date: March 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EkoSonic Treatment Arm
Patients receive 24 mg of recombinant tissue plasminogen activator delivered through the EkoSonic Endovascular System.
 Drug: recombinant tissue plasminogen activator
Patients receive 24 mg of recombinant tissue plasminogen activator delivered via the EkoSonic Endovascular Device.
Other Names:
  • rt-PA
  • t-PA
  • Alteplase
Device: EKOS EkoSonic Endovascular System
24 mg of recombinant tissue plasminogen activator delivered through the EkoSonic Endovascular System.
Other Names:
  • EkoSonic Endovascular Device
  • EkoSonic
Drug: Alteplase
Patients receive 24 mg of alteplase delivered via the EkoSonic Endovascular Device
Other Name: EkoSonic Endovascular System

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • CT evidence of proximal PE (filling defect in at least one main or segmental pulmonary artery) AND
  • Age ≥ 18 years AND
  • PE symptom duration ≤14 days AND
  • Informed consent can be obtained from subject or Legally Authorized Representative (LAR) AND
  • Massive PE (syncope, systemic arterial hypotension, cardiogenic shock, or resuscitated cardiac arrest) OR
  • Submassive PE (RV diameter-to-LV diameter ≥ 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 < 30%
  • Platelets < 100 thousand/μL
  • INR > 3
  • aPTT > 50 seconds on no anticoagulants
  • Major surgery within seven days
  • Serum creatinine > 2 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01513759

Contacts
Contact: Samuel Z Goldhaber, MD SGOLDHABER@PARTNERS.ORG
Contact: Piazza Greg, MD GPIAZZA@PARTNERS.ORG

  Hide Study Locations
Locations
United States, Alabama
Baptist Health Recruiting
Montgomery, Alabama, United States, 36116
Contact: Narinder Bhalla, MD         narinderbhalla@rocketmail.com    
Principal Investigator: Narinder Bhalla, MD            
Sub-Investigator: Mohammad Luqman Ahmed, MD            
Sub-Investigator: Thomas Wool, MD            
Sub-Investigator: Eric Crum, MD            
Sub-Investigator: Pervais Malik, MD            
Sub-Investigator: Dilip Patel, MD            
Sub-Investigator: Ralph Rhedd, MD            
United States, California
Memorial Medical Center Recruiting
Modesto, California, United States, 95355
Contact: Stephen Liu, MD         stevekliu@yahoo.com    
Principal Investigator: Stephen Liu, MD            
Sub-Investigator: Bruce Lin, MD            
Stanford University Medical Center Recruiting
Stanford, California, United States, 94305
Contact: William Kuo, MD         wkuo@stanford.edu    
Principal Investigator: William Kuo, MD            
United States, Connecticut
Hartford Hospital Recruiting
Hartford, Connecticut, United States
Contact: Immad Sadiq, MD         isadiq@harthosp.org    
Principal Investigator: Immad Sadiq, MD            
Sub-Investigator: Parth Shah, MD            
Sub-Investigator: Mohiuddin Cheema, MD            
Sub-Investigator: Robert Spillane, MD            
Sub-Investigator: Thomas Divinagracia, MD            
Sub-Investigator: Barry Stein, MD            
Sub-Investigator: Talhat Azemi, MD            
United States, Delaware
Christiana Hospital Not yet recruiting
Newark, Delaware, United States, 19718
Contact: Mark Garcia, MD         mgarcia@christianacare.org    
Principal Investigator: Mark Garcia, MD            
United States, Florida
Lakeland Regional Medical Center Not yet recruiting
Lakeland, Florida, United States, 33805
Contact: Fakhir Elmasri, MD         felmasri@me.com    
Principal Investigator: Fakhir Elmasri, MD            
Holmes Regional Medical Center Recruiting
Melbourne, Florida, United States, 32901
Contact: Robert Kennedy, MD         rkennedymd@gmail.com    
Principal Investigator: Robert Kennedy, MD            
Sub-Investigator: Brian Dunfee, MD            
Sub-Investigator: Hai Kenney, MD            
Florida Hospital Recruiting
Orlando, Florida, United States, 32803
Contact: Rohit Bhatheja, MD         rbhatheja@fhg.org    
Principal Investigator: Rohit Bhatheja, MD            
Sub-Investigator: J Moskovitz, MD            
Orlando Regional Medical Center Recruiting
Orlando, Florida, United States, 32806
Contact: Barry Weinstock, MD         heartdoc1bw@gmail.com    
Principal Investigator: Barry Weinstock, MD            
Sub-Investigator: Deepak Vivek, MD            
Sub-Investigator: Ronald Domescek, MD            
Sub-Investigator: Mark Steiner, MD            
Sub-Investigator: Vijaykumar Kasi, MD            
Sub-Investigator: Nipun Arora, MD            
United States, Georgia
Medical Center of Central Georgia Recruiting
Macon, Georgia, United States, 31201
Contact: Juan Ayerdi, MD         jayerdi3@cox.net    
Principal Investigator: Juan Ayerdi, MD            
Sub-Investigator: Maurice Solis, MD            
Sub-Investigator: J. William Mix, MD            
United States, Illinois
Prairie Heart Institue Recruiting
Springfield, Illinois, United States, 62701
Contact: Nilesh Goswami, MD         ngaswami@prairieheart.com    
Principal Investigator: Nilesh Goswami, MD            
Sub-Investigator: Shalesh Nandesh, MD            
Sub-Investigator: Robert Trask, MD            
Sub-Investigator: Frank Aguirre, MD            
Sub-Investigator: Greg Mishkel, MD            
Sub-Investigator: Michael Kelley, MD            
Sub-Investigator: Jeffrey Goldstein, MD            
Sub-Investigator: John Gill, MD            
Sub-Investigator: Gabor Matos, MD            
United States, Indiana
St. Vincent Hospital Recruiting
Indianapolis, Indiana, United States
Contact: Kannan Natarajan, MD         knatarajan@indy.rr.com    
Principal Investigator: Kannan Natarajan, MD            
Sub-Investigator: Brandon Martinez, MD            
Sub-Investigator: Jeffrey Cooke, MD            
Sub-Investigator: Marc Underhill, MD            
United States, Kentucky
University of Kentucky, Gill Heart Institute Recruiting
Lexington, Kentucky, United States, 40536
Contact: John Gurley, MD         mechanic@therixmedical.com    
Principal Investigator: John Gurley, MD            
Sub-Investigator: Joseph Foley, MD            
Sub-Investigator: David Booth, MD            
Sub-Investigator: Khaled Ziada, MD            
Sub-Investigator: Ahmed Abdel-Latif, MD            
Sub-Investigator: Charles Campbell, MD            
Sub-Investigator: Lawrence Rajan, MD            
United States, Louisiana
East Jefferson General Hospital Recruiting
New Orleans, Louisiana, United States, 70006
Contact: Tod Engelhardt, MD         tengelha@ejgh.org    
Principal Investigator: Tod Engelhardt, MD            
Sub-Investigator: Gary Menszer, MD            
Sub-Investigator: Sean O'Brien, MD            
United States, New Jersey
Hackensack University Medical Center Not yet recruiting
Hackensack, New Jersey, United States, 07601
Contact: Gregory Simonian, MD         gsimonian@aol.com    
Principal Investigator: Greg Simonian, MD            
Overlook Medical Center Recruiting
Morristown, New Jersey, United States, 07960
Contact: Mark Kumar, MD         mhkumar96@gmail.com    
Principal Investigator: Mark Kumar, MD            
Holy Name Hospital Recruiting
Teaneck, New Jersey, United States, 07666
Contact: John Rundback, MD         rundback@mail.holyname.org    
Principal Investigator: John Rundback, MD            
Sub-Investigator: Kevin Herman, MD            
Sub-Investigator: David Singh, MD            
United States, New York
Montefiore Not yet recruiting
Bronx, New York, United States, 10467
Contact: Jacob Cynamon, MD         jcynamon@montefiore.org    
Principal Investigator: Jacob Cynamon, MD            
United States, Ohio
Mt. Carmel East Recruiting
Columbus, Ohio, United States, 43213
Contact: Noah Jones, MD         noahj4@gmail.com    
Principal Investigator: Noah Jones, MD            
Sub-Investigator: Asok Dasgupta, MD            
Sub-Investigator: Rob Irsik, MD            
Sub-Investigator: David Hunt, MD            
Sub-Investigator: Jim Klein, MD            
United States, Rhode Island
The Miriam Hospital Not yet recruiting
Providence, Rhode Island, United States, 02906
Contact: Peter Soukas, MD         psoukas@lifespan.org    
Principal Investigator: Peter Soukas, MD            
United States, Texas
Providence Memorial and Sierra Medical Center Recruiting
El Paso, Texas, United States, 79902
Contact: Mohammad Raja, MD         rajamohammad@hotmail.com    
Principal Investigator: Mohammad Raja, MD            
United States, Virginia
Inova Alexandria Hospital Recruiting
Alexandria, Virginia, United States, 22304
Contact: Keith Sterling, MD         ksterling@alexandriaradiology.com    
Principal Investigator: Keith Sterling, MD            
Sub-Investigator: James Cooper, MD            
Sub-Investigator: Arina Van Breda, MD            
Sub-Investigator: Dimitrios Papandouris, MD            
Sub-Investigator: Sandeep Bagla, MD            
Sub-Investigator: Ken Rholl, MD            
Sponsors and Collaborators
EKOS Corporation
Investigators
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.
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
Principal Investigator: Mark Kumar, MD Overlook Medical Center- Atlantic Center for Research
Principal Investigator: Laiq Raja, M.D. Providence Memorial Hospital & Sierra Medical Center
Principal Investigator: William Kuo, M.D. Stanford University
Principal Investigator: Mark Garcia, MD Christiana Hospital
  More Information

No publications provided

Responsible Party: EKOS Corporation
ClinicalTrials.gov Identifier: NCT01513759     History of Changes
Other Study ID Numbers: EKOS 09
Study First Received: January 17, 2012
Last Updated: March 25, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by EKOS Corporation:
Fibrinolysis
catheter directed fibrinolysis
ultrasound accelerated fibrinolysis
recombinant t-PA
Activase

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Thrombosis
 Plasminogen
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents

ClinicalTrials.gov processed this record on May 16, 2013