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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
EKOS Corporation
ClinicalTrials.gov Identifier:
NCT01513759
First received: January 17, 2012
Last updated: June 11, 2013
Last verified: June 2013
  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:


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.


Enrollment: 150
Study Start Date: May 2012
Study Completion Date: April 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01513759

  Show 22 Study Locations
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: June 11, 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
Cardiovascular Diseases
Embolism and Thrombosis
Lung Diseases
Respiratory Tract Diseases
Thrombosis
Vascular Diseases
Plasminogen
Tissue Plasminogen Activator
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014