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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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Pulmonary Embolism
Acute Pulmonary Embolism
Sub-massive Pulmonary Embolism
Massive Pulmonary Embolism
Pulmonary Thromboembolism
Interventions Drug: recombinant tissue plasminogen activator
Device: EKOS EkoSonic Endovascular System
Enrollment 150
Recruitment Details  
Pre-assignment Details  
Arm/Group Title EkoSonic® Endovascular System
Hide Arm/Group Description Participants received a total of 24 milligrams (mg) of recombinant tissue plasminogen activator (r-tPA) infusion, at an infusion rate of 1 milligrams/hour (mg/hr) per device (2 mg/hour for bilateral pulmonary embolism [PE]) delivered through the EkoSonic® Endovascular System. This regimen allowed for a r-tPA infusion time of 24 hours for one catheter and 12 hours for two catheters, respectively.
Period Title: Overall Study
Started 150
At Least One Device Successfully Placed 149
Completed 145
Not Completed 5
Reason Not Completed
Protocol Violation             4
Death during catheter placement             1
Arm/Group Title EkoSonic® Endovascular System
Hide Arm/Group Description Participants received a total of 24 mg of r-tPA infusion at an infusion rate of 1 mg/hr per device (2 mg/hour for bilateral PE) delivered through the EkoSonic® Endovascular System. This regimen allowed for a r-tPA infusion time of 24 hours for one catheter and 12 hours for two catheters, respectively.
Overall Number of Baseline Participants 150
Hide Baseline Analysis Population Description
Efficacy analysis set included all participants who started the ultrasound accelerated thrombolysis therapy.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 150 participants
59.0  (16.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 150 participants
Female
73
  48.7%
Male
77
  51.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 150 participants
Caucasian, Not of Hispanic Origin
119
  79.3%
African American, Not of Hispanic Origin
22
  14.7%
Hispanic or Latino
9
   6.0%
1.Primary Outcome
Title Change From Baseline in the Right Ventricle (RV) Diameter-to-Left Ventricle (LV) Diameter Ratio Within 48 +/- 6 Hours of Initiation of Therapy
Hide Description 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.
Time Frame Baseline, within 48 +/- 6 hours of initiation of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set included all participants who started the ultrasound accelerated thrombolysis therapy. Here, 'Overall number of participants analyzed' signifies participants with available data at both baseline and post-baseline. 'Number analyzed' signifies participants with available data at specified timepoint.
Arm/Group Title EkoSonic® Endovascular System
Hide Arm/Group Description:
Participants received a total of 24 mg of r-tPA infusion, at an infusion rate of 1 mg/hr per device (2 mg/hour for bilateral PE) delivered through the EkoSonic® Endovascular System. This regimen allowed for a r-tPA infusion time of 24 hours for one catheter and 12 hours for two catheters, respectively.
Overall Number of Participants Analyzed 150
Mean (Standard Deviation)
Unit of Measure: ratio
Baseline Number Analyzed 123 participants
1.55  (0.39)
Change within 48 +/- 6 hours Number Analyzed 115 participants
-0.42  (0.36)
2.Primary Outcome
Title Number of Participants With Major Bleeding
Hide Description 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.
Time Frame From start of study drug infusion up to 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who started the EkoSonic device placement procedure.
Arm/Group Title EkoSonic® Endovascular System
Hide Arm/Group Description:
Participants received a total of 24 mg of r-tPA infusion, at an infusion rate of 1 mg/hr per device (2 mg/hour for bilateral PE) delivered through the EkoSonic® Endovascular System. This regimen allowed for a r-tPA infusion time of 24 hours for one catheter and 12 hours for two catheters, respectively.
Overall Number of Participants Analyzed 150
Measure Type: Count of Participants
Unit of Measure: Participants
14
   9.3%
3.Secondary Outcome
Title Change From Baseline in Pulmonary Artery Systolic Pressure at 48 Hours After Start of Therapy
Hide Description 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.
Time Frame Baseline, Hour 48 after initiation of therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set included all participants who started the ultrasound accelerated thrombolysis therapy. Here, 'Number analyzed' signifies participants with available data at specified timepoint.
Arm/Group Title EkoSonic® Endovascular System
Hide Arm/Group Description:
Participants received a total of 24 mg of r-tPA infusion, at an infusion rate of 1 mg/hr per device (2 mg/hour for bilateral PE) delivered through the EkoSonic® Endovascular System. This regimen allowed for a r-tPA infusion time of 24 hours for one catheter and 12 hours for two catheters, respectively.
Overall Number of Participants Analyzed 150
Mean (Standard Deviation)
Unit of Measure: millimeters of mercury (mmHg)
Baseline Number Analyzed 150 participants
51.4  (16)
Change at Hour 48 Number Analyzed 98 participants
-14.4  (15.4)
4.Secondary Outcome
Title Percentage of Participants With Symptomatic Recurrent Pulmonary Embolism (PE)
Hide Description 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.
Time Frame Baseline up to Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set included all participants who started the ultrasound accelerated thrombolysis therapy. One participant was excluded from this analysis due to lost to follow-up after discharge.
Arm/Group Title EkoSonic® Endovascular System
Hide Arm/Group Description:
Participants received a total of 24 mg of r-tPA infusion, at an infusion rate of 1 mg/hr per device (2 mg/hour for bilateral PE) delivered through the EkoSonic® Endovascular System. This regimen allowed for a r-tPA infusion time of 24 hours for one catheter and 12 hours for two catheters, respectively.
Overall Number of Participants Analyzed 149
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0 to 2.5)
5.Secondary Outcome
Title Number of Participants Who Died Due to Any Cause
Hide Description 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.
Time Frame Baseline up to Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis set included all participants who started the ultrasound accelerated thrombolysis therapy. One participant was excluded from this analysis due to lost to follow-up after discharge.
Arm/Group Title EkoSonic® Endovascular System
Hide Arm/Group Description:
Participants received a total of 24 mg of r-tPA infusion, at an infusion rate of 1 mg/hr per device (2 mg/hour for bilateral PE) delivered through the EkoSonic® Endovascular System. This regimen allowed for a r-tPA infusion time of 24 hours for one catheter and 12 hours for two catheters, respectively.
Overall Number of Participants Analyzed 149
Measure Type: Count of Participants
Unit of Measure: Participants
4
   2.7%
6.Secondary Outcome
Title Number of Devices That Could Not be Successfully Used for Infusion
Hide Description Technical complications associated with the use of the EkoSonic device was recorded during catheter placement in the pulmonary artery and during the infusion procedure.
Time Frame Baseline up to Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who started the EkoSonic device placement procedure.
Arm/Group Title EkoSonic® Endovascular System
Hide Arm/Group Description:
Participants received a total of 24 mg of r-tPA infusion, at an infusion rate of 1 mg/hr per device (2 mg/hour for bilateral PE) delivered through the EkoSonic® Endovascular System. This regimen allowed for a r-tPA infusion time of 24 hours for one catheter and 12 hours for two catheters, respectively.
Overall Number of Participants Analyzed 150
Overall Number of Units Analyzed
Type of Units Analyzed: Devices
285
Count of Units
Unit of Measure: devices
7
   2.5%
Time Frame Baseline up to Day 30
Adverse Event Reporting Description Safety analysis set included all participants who started the EkoSonic device placement procedure.
 
Arm/Group Title EkoSonic® Endovascular System
Hide Arm/Group Description Participants received a total of 24 mg of r-tPA infusion, at an infusion rate of 1 mg/hr per device (2 mg/hour for bilateral PE) delivered through the EkoSonic® Endovascular System. This regimen allowed for a r-tPA infusion time of 24 hours for one catheter and 12 hours for two catheters, respectively.
All-Cause Mortality
EkoSonic® Endovascular System
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
EkoSonic® Endovascular System
Affected / at Risk (%)
Total   28/150 (18.67%) 
Blood and lymphatic system disorders   
Anemia  1  3/150 (2.00%) 
Heparin-induced thrombocytopenia  1  1/150 (0.67%) 
Haemorrhagic anaemia  1  1/150 (0.67%) 
Cardiac disorders   
Atrial flutter  1  1/150 (0.67%) 
Atrial fibrillation  1  1/150 (0.67%) 
Pericardial effusion  1  1/150 (0.67%) 
General disorders   
Chest Pain  1  1/150 (0.67%) 
Infections and infestations   
Sepsis  1  1/150 (0.67%) 
Injury, poisoning and procedural complications   
Vascular pseudoaneurysm  1  1/150 (0.67%) 
Investigations   
Electroencephalogram abnormal  1  1/150 (0.67%) 
Renal and urinary disorders   
Haematuria  1  2/150 (1.33%) 
Renal failure acute  1  2/150 (1.33%) 
Respiratory, thoracic and mediastinal disorders   
Acute respiratory failure  1  2/150 (1.33%) 
Dyspnoea  1  2/150 (1.33%) 
Hypoxia  1  1/150 (0.67%) 
Pleural effusion  1  1/150 (0.67%) 
Pulmonary arterial hypertension  1  1/150 (0.67%) 
Pulmonary embolism  1  1/150 (0.67%) 
Respiratory failure  1  2/150 (1.33%) 
Epistaxis  1  1/150 (0.67%) 
Vascular disorders   
Deep vein thrombosis  1  3/150 (2.00%) 
Haematoma  1  3/150 (2.00%) 
Hypotension  1  1/150 (0.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
EkoSonic® Endovascular System
Affected / at Risk (%)
Total   59/150 (39.33%) 
Blood and lymphatic system disorders   
Anemia  1  6/150 (4.00%) 
Haemorrhagic anaemia  1  1/150 (0.67%) 
Heparin-induced thrombocytopenia  1  1/150 (0.67%) 
Leukocytosis  1  1/150 (0.67%) 
Thrombocytopenia  1  4/150 (2.67%) 
Cardiac disorders   
Atrial fibrillation  1  2/150 (1.33%) 
Ventricular arrhythmia  1  1/150 (0.67%) 
Chest pain  1  1/150 (0.67%) 
Pyrexia  1  2/150 (1.33%) 
Gastrointestinal disorders   
Abdominal pain  1  2/150 (1.33%) 
Abdominal wall haematoma  1  1/150 (0.67%) 
Constipation  1  2/150 (1.33%) 
Diarrhoea  1  2/150 (1.33%) 
Gastrointestinal haemorrhage  1  1/150 (0.67%) 
Nausea  1  1/150 (0.67%) 
Vomiting  1  1/150 (0.67%) 
General disorders   
Chest discomfort  1  4/150 (2.67%) 
Infections and infestations   
Cellulitis  1  2/150 (1.33%) 
Pneumonia  1  2/150 (1.33%) 
Urinary Tract Infection  1  5/150 (3.33%) 
Injury, poisoning and procedural complications   
Arterial injury  1  1/150 (0.67%) 
Contusion  1  1/150 (0.67%) 
Operative haemorrhage  1  1/150 (0.67%) 
Wound secretion  1  1/150 (0.67%) 
Investigations   
Blood creatinine increased  1  1/150 (0.67%) 
Blood glucose increased  1  1/150 (0.67%) 
Blood pressure decreased  1  1/150 (0.67%) 
Electrocardiogram abnormal  1  2/150 (1.33%) 
Metabolism and nutrition disorders   
Diabetes mellitus  1  1/150 (0.67%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  1/150 (0.67%) 
Facial asymmetry  1  1/150 (0.67%) 
Groin pain  1  1/150 (0.67%) 
Muscle haemorrhage  1  1/150 (0.67%) 
Pain in extremity  1  1/150 (0.67%) 
Musculoskeletal stiffness  1  1/150 (0.67%) 
Nervous system disorders   
Convulsion  1  1/150 (0.67%) 
Psychiatric disorders   
Mental status changes  1  1/150 (0.67%) 
Renal and urinary disorders   
Haematuria  1  1/150 (0.67%) 
Renal failure acute  1  3/150 (2.00%) 
Renal failure chronic  1  2/150 (1.33%) 
Nephrolithiasis  1  1/150 (0.67%) 
Respiratory, thoracic and mediastinal disorders   
Epistaxis  1  3/150 (2.00%) 
Dyspnoea  1  2/150 (1.33%) 
Haemoptysis  1  5/150 (3.33%) 
Oropharyngeal pain  1  1/150 (0.67%) 
Pleural effusion  1  3/150 (2.00%) 
Pulmonary oedema  1  1/150 (0.67%) 
Skin and subcutaneous tissue disorders   
Ecchymosis  1  2/150 (1.33%) 
Rash erythematous  1  1/150 (0.67%) 
Vascular disorders   
Haematoma  1  10/150 (6.67%) 
Deep vein thrombosis  1  3/150 (2.00%) 
Hypertension  1  1/150 (0.67%) 
Hypotension  1  1/150 (0.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: David Hahn
Organization: EKOS Corporation
Phone: 4254153100
EMail: David.Hahn@btgplc.com
Layout table for additonal information
Responsible Party: EKOS Corporation
ClinicalTrials.gov Identifier: NCT01513759     History of Changes
Other Study ID Numbers: EKOS 09
First Submitted: January 17, 2012
First Posted: January 20, 2012
Results First Submitted: June 10, 2019
Results First Posted: July 3, 2019
Last Update Posted: July 3, 2019