Title

Submassive and Massive Pulmonary Embolism Treatment With Ultrasound Accelerated Thrombolysis Therapy
A Prospective, Single-Arm, Multi-Center Trial of EkoSonic® Endovascular System and Activase for Treatment of Acute Pulmonary Embolism (PE)
  • Phase

    Phase 3
  • Study Type

    Interventional
  • Intervention/Treatment

    alteplase ...
  • Study Participants

    150
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.
Study Started
Jun 07
2012
Primary Completion
Feb 17
2013
Study Completion
Feb 17
2013
Results Posted
Jul 05
2019
Last Update
Jul 19
2021

Drug recombinant tissue plasminogen activator

Participants will receive 24 mg of r-tPA delivered via the EkoSonic Endovascular Device.

  • Other names: r-tPA, t-PA, Alteplase

Device EKOS EkoSonic Endovascular System

24 mg of r-tPA will be delivered through the EkoSonic Endovascular System.

  • Other names: EkoSonic Endovascular Device, EkoSonic

EkoSonic® Endovascular System Experimental

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.

Criteria

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

Summary

EkoSonic® Endovascular System

All Events

Event Type Organ System Event Term 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

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.

EkoSonic® Endovascular System

Baseline

1.55
ratio (Mean)
Standard Deviation: 0.39

Change within 48 +/- 6 hours

-0.42
ratio (Mean)
Standard Deviation: 0.36

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.

EkoSonic® Endovascular System

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.

EkoSonic® Endovascular System

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.

EkoSonic® Endovascular System

Baseline

51.4
millimeters of mercury (mmHg) (Mean)
Standard Deviation: 16

Change at Hour 48

-14.4
millimeters of mercury (mmHg) (Mean)
Standard Deviation: 15.4

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.

EkoSonic® Endovascular System

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.

EkoSonic® Endovascular System

Age, Continuous

59.0
Years (Mean)
Standard Deviation: 16.1

Race/Ethnicity, Customized

Sex: Female, Male

Overall Study

EkoSonic® Endovascular System

Drop/Withdrawal Reasons

EkoSonic® Endovascular System