Submassive and Massive Pulmonary Embolism Treatment With Ultrasound Accelerated Thrombolysis Therapy

• Status: Completed
• Trial end date: 2013-02-17
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston Scientific Corporation; EKOS Corporation
• Collaborator: EKOS Corporation
• Treatments: Plasminogen; Tissue Plasminogen Activator

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