Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01513759
Other study ID # EKOS 09
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT05050617 - Point-of-Care Ultrasound in Predicting Adverse Outcomes in Emergency Department Patients With Acute Pulmonary Embolism
Terminated NCT04558125 - Low-Dose Tenecteplase in Covid-19 Diagnosed With Pulmonary Embolism Phase 4
Not yet recruiting NCT06017271 - Predictive Value of Epicardial Adipose Tissue for Pulmonary Embolism and Death in Patients With Lung Cancer
Completed NCT03915925 - Short-term Clinical Deterioration After Acute Pulmonary Embolism
Completed NCT02502396 - Rivaroxaban Utilization for Treatment and Prevention of Thromboembolism in Cancer Patients: Experience at a Comprehensive Cancer Center
Recruiting NCT05171075 - A Study Comparing Abelacimab to Dalteparin in the Treatment of Gastrointestinal/Genitourinary Cancer and Associated VTE Phase 3
Completed NCT04454554 - Prevalence of Pulmonary Embolism in Patients With Dyspnea on Exertion (PEDIS)
Completed NCT03173066 - Ferumoxytol as a Contrast Agent for Pulmonary Magnetic Resonance Angiography Phase 1
Terminated NCT03002467 - Impact Analysis of Prognostic Stratification for Pulmonary Embolism N/A
Completed NCT02334007 - Extended Low-Molecular Weight Heparin VTE Prophylaxis in Thoracic Surgery Phase 1/Phase 2
Completed NCT02611115 - Optimizing Protocols for the Individual Patient in CT Pulmonary Angiography. N/A
Completed NCT01975090 - The SENTRY Clinical Study N/A
Not yet recruiting NCT01357941 - Need for Antepartum Thromboprophylaxis in Pregnant Women With One Prior Episode of Venous Thromboembolism (VTE) N/A
Completed NCT01326507 - Prognostic Value of Heart-type Fatty Acid-Binding Protein (h-FABP) in Acute Pulmonary Embolism N/A
Completed NCT00773448 - Screening for Occult Malignancy in Patients With Idiopathic Venous Thromboembolism N/A
Completed NCT02476526 - Safety of Low Dose IV Contrast CT Scanning in Chronic Kidney Disease Phase 4
Completed NCT00780767 - Angiojet Rheolytic Thrombectomy in Case of Massive Pulmonary Embolism Phase 2
Completed NCT00771303 - Ruling Out Pulmonary Embolism During Pregnancy:a Multicenter Outcome Study
Completed NCT00720915 - D-dimer to Select Patients With First Unprovoked Venous Thromboembolism Who Can Have Anticoagulants Stopped at 3 Months N/A
Completed NCT00816920 - Natural History of Isolated Deep Vein Thrombosis of the Calf