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OpenTrials
Completed

NCT Number: NCT01513759

Submassive and Massive Pulmonary Embolism Treatment With Ultrasound Accelerated Thrombolysis Therapy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Baptist Health, Montgomery, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

recombinant tissue plasminogen activator

Drug

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

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

EKOS EkoSonic Endovascular System

Device

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

Other names: EkoSonic Endovascular Device, EkoSonic

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Collaborators

  • EKOS Corporation

Registry information

Official study title

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

Acronym: SEATTLE II

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 20, 2012
Registry last updated
Jul 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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