Submassive and Massive Pulmonary Embolism Treatment With Ultrasound Accelerated Thrombolysis Therapy

Pulmonary Embolism Clinical Trial

— SEATTLE II  

Official title:

A Prospective, Single-Arm, Multi-Center Trial of EkoSonic® Endovascular System and Activase for Treatment of Acute Pulmonary Embolism (PE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01513759
• Other study ID #: EKOS 09
• Status: Completed
• Phase: Phase 3
• Start date: June 7, 2012
• Est. completion date: February 17, 2013

Study information

• Verified date: July 2021
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if the EKOS EkoSonic® Endovascular Device when used in conjunction with recombinant tissue plasminogen activator (t-PA) as a treatment for acute PE will decrease the ratio of right ventricle (RV) to left ventricle (LV) diameter within 48 =/- 6 hours in participants with massive or submassive PE.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: February 17, 2013
• Est. primary completion date: February 17, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Computed tomography (CT) evidence of proximal PE (filling defect in at least one main or segmental pulmonary artery)

• 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:

• 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 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

Related Conditions & MeSH terms

• Acute Pulmonary Embolism
• Embolism
• Massive Pulmonary Embolism
• Pulmonary Embolism
• Pulmonary Thromboembolism
• Sub-massive Pulmonary Embolism
• Thromboembolism

Intervention

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.

Locations

Country	Name	City	State
United States	Inova Alexandria Hospital	Alexandria	Virginia
United States	Montefiore Medical Center	Bronx	New York
United States	Mt. Carmel East	Columbus	Ohio
United States	Providence Memorial and Sierra Medical Center	El Paso	Texas
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Hartford Hospital	Hartford	Connecticut
United States	St. Vincent Hospital	Indianapolis	Indiana
United States	Lakeland Regional Medical Center	Lakeland	Florida
United States	University of Kentucky, Gill Heart Institute	Lexington	Kentucky
United States	Medical Center of Central Georgia	Macon	Georgia
United States	Holmes Regional Medical Center	Melbourne	Florida
United States	Memorial Medical Center	Modesto	California
United States	Baptist Health	Montgomery	Alabama
United States	Overlook Medical Center	Morristown	New Jersey
United States	East Jefferson General Hospital	New Orleans	Louisiana
United States	Christiana Hospital	Newark	Delaware
United States	Florida Hospital	Orlando	Florida
United States	Orlando Regional Medical Center	Orlando	Florida
United States	The Miriam Hospital	Providence	Rhode Island
United States	Prairie Heart Institute	Springfield	Illinois
United States	Stanford University Medical Center	Stanford	California
United States	Holy Name Hospital	Teaneck	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Boston Scientific Corporation	EKOS Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in the Right Ventricle (RV) Diameter-to-Left Ventricle (LV) Diameter Ratio 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.	Baseline, within 48 +/- 6 hours of initiation of therapy
Primary	Number of Participants With Major Bleeding	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.	From start of study drug infusion up to 72 hours
Secondary	Change From Baseline in Pulmonary Artery Systolic Pressure at 48 Hours After Start 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.	Baseline, Hour 48 after initiation of therapy
Secondary	Percentage of Participants With Symptomatic Recurrent Pulmonary Embolism (PE)	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.	Baseline up to Day 30
Secondary	Number of Participants Who Died Due to Any Cause	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.	Baseline up to Day 30
Secondary	Number of Devices That Could Not be Successfully Used for Infusion	Technical complications associated with the use of the EkoSonic device was recorded during catheter placement in the pulmonary artery and during the infusion procedure.	Baseline up to Day 30