Submassive and Massive Pulmonary Embolism Treatment With Ultrasound Accelerated Thrombolysis Therapy (SEATTLE II)
|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: NCT01513759|
Recruitment Status : Completed
First Posted : January 20, 2012
Results First Posted : July 5, 2019
Last Update Posted : July 5, 2019
|Condition or disease||Intervention/treatment||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||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Single-Arm, Multi-Center Trial of EkoSonic® Endovascular System and Activase for Treatment of Acute Pulmonary Embolism (PE)|
|Actual Study Start Date :||June 7, 2012|
|Actual Primary Completion Date :||February 17, 2013|
|Actual Study Completion Date :||February 17, 2013|
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.
Drug: recombinant tissue plasminogen activator
Participants will receive 24 mg of r-tPA delivered via the EkoSonic Endovascular Device.
Device: EKOS EkoSonic Endovascular System
24 mg of r-tPA will be delivered through the EkoSonic Endovascular System.
- 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.
- 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.
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): NCT01513759
|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|