Submassive and Massive Pulmonary Embolism Treatment With Ultrasound Accelerated Thrombolysis Therapy
NCT ID: NCT01513759
Last Updated: 2021-07-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
150 participants
INTERVENTIONAL
2012-06-07
2013-02-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
recombinant tissue plasminogen activator
Participants will receive 24 mg of r-tPA delivered via the EkoSonic Endovascular Device.
EKOS EkoSonic Endovascular System
24 mg of r-tPA will be delivered through the EkoSonic Endovascular System.
Interventions
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recombinant tissue plasminogen activator
Participants will receive 24 mg of r-tPA delivered via the EkoSonic Endovascular Device.
EKOS EkoSonic Endovascular System
24 mg of r-tPA will be delivered through the EkoSonic Endovascular System.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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EKOS Corporation
INDUSTRY
Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Narinder Bhalla, MD
Role: PRINCIPAL_INVESTIGATOR
Baptist Health
William Kuo, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford Hospital and Clinics
Stephen K Liu, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Medical Center - Modesto
Immad Sidiq, MD
Role: PRINCIPAL_INVESTIGATOR
Hartford Hospital
Samuel Z Goldhaber, MD
Role: STUDY_CHAIR
Brigham and Women's
Mark J Garcia, MD
Role: PRINCIPAL_INVESTIGATOR
Christiana Hospital
Rohit Bhatheja, MD
Role: PRINCIPAL_INVESTIGATOR
AdventHealth
Robert Kennedy, MD
Role: PRINCIPAL_INVESTIGATOR
Holmes Regional Medical Center
Fakhir Elmasri, MD
Role: PRINCIPAL_INVESTIGATOR
Lakeland Regional Medical Center
Barry S Weinstock, MD
Role: PRINCIPAL_INVESTIGATOR
Orlando Regional Medical Center
Juan Ayerdi, MD
Role: PRINCIPAL_INVESTIGATOR
Medical Center of Central Georgia
Nilesh Goswami, MD
Role: PRINCIPAL_INVESTIGATOR
Prairie Heart Institute - St.John's Hospital
Kannan Natarajan, MD
Role: PRINCIPAL_INVESTIGATOR
St Vincent's Hospital
Tod C Engelhardt, MD
Role: PRINCIPAL_INVESTIGATOR
East Jefferson General Hospital
Mark Kumar, MD
Role: PRINCIPAL_INVESTIGATOR
Overlook Medical Center
John Rundback, MD
Role: PRINCIPAL_INVESTIGATOR
Holy Name Hospital
Jacob Cynamon, MD
Role: PRINCIPAL_INVESTIGATOR
Montefiore Medical Center
Peter Soukas, MD
Role: PRINCIPAL_INVESTIGATOR
The Miriam Hospital
Mohammad L Raja, MD
Role: PRINCIPAL_INVESTIGATOR
Providence Memorial Hospital - Sierra Vista Hospital
Keith M Sterling, MD
Role: PRINCIPAL_INVESTIGATOR
Inova Alexandria
John Gurley, MD
Role: PRINCIPAL_INVESTIGATOR
University of Kentucky
Noah Jones, MD
Role: PRINCIPAL_INVESTIGATOR
Mt. Carmel East
Locations
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Baptist Health
Montgomery, Alabama, United States
Memorial Medical Center
Modesto, California, United States
Stanford University Medical Center
Stanford, California, United States
Hartford Hospital
Hartford, Connecticut, United States
Christiana Hospital
Newark, Delaware, United States
Lakeland Regional Medical Center
Lakeland, Florida, United States
Holmes Regional Medical Center
Melbourne, Florida, United States
Florida Hospital
Orlando, Florida, United States
Orlando Regional Medical Center
Orlando, Florida, United States
Medical Center of Central Georgia
Macon, Georgia, United States
Prairie Heart Institute
Springfield, Illinois, United States
St. Vincent Hospital
Indianapolis, Indiana, United States
University of Kentucky, Gill Heart Institute
Lexington, Kentucky, United States
East Jefferson General Hospital
New Orleans, Louisiana, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Overlook Medical Center
Morristown, New Jersey, United States
Holy Name Hospital
Teaneck, New Jersey, United States
Montefiore Medical Center
The Bronx, New York, United States
Mt. Carmel East
Columbus, Ohio, United States
The Miriam Hospital
Providence, Rhode Island, United States
Providence Memorial and Sierra Medical Center
El Paso, Texas, United States
Inova Alexandria Hospital
Alexandria, Virginia, United States
Countries
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References
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Sadiq I, Goldhaber SZ, Liu PY, Piazza G; Submassive and Massive Pulmonary Embolism Treatment with Ultrasound AcceleraTed ThromboLysis ThErapy (SEATTLE II) Investigators. Risk factors for major bleeding in the SEATTLE II trial. Vasc Med. 2017 Feb;22(1):44-50. doi: 10.1177/1358863X16676355. Epub 2017 Jan 31.
Piazza G, Hohlfelder B, Jaff MR, Ouriel K, Engelhardt TC, Sterling KM, Jones NJ, Gurley JC, Bhatheja R, Kennedy RJ, Goswami N, Natarajan K, Rundback J, Sadiq IR, Liu SK, Bhalla N, Raja ML, Weinstock BS, Cynamon J, Elmasri FF, Garcia MJ, Kumar M, Ayerdi J, Soukas P, Kuo W, Liu PY, Goldhaber SZ; SEATTLE II Investigators. A Prospective, Single-Arm, Multicenter Trial of Ultrasound-Facilitated, Catheter-Directed, Low-Dose Fibrinolysis for Acute Massive and Submassive Pulmonary Embolism: The SEATTLE II Study. JACC Cardiovasc Interv. 2015 Aug 24;8(10):1382-1392. doi: 10.1016/j.jcin.2015.04.020.
Other Identifiers
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EKOS 09
Identifier Type: -
Identifier Source: org_study_id
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