Submassive and Massive Pulmonary Embolism Treatment With Ultrasound Accelerated Thrombolysis Therapy (SEATTLE II)

Boston Scientific

Status and phase: Completed; Phase 3

Conditions: Pulmonary Embolism; Acute Pulmonary Embolism; Pulmonary Thromboembolism; Massive Pulmonary Embolism; Sub-massive Pulmonary Embolism

Treatments: Device: EKOS EkoSonic Endovascular System; Drug: recombinant tissue plasminogen activator

Study type: Interventional

Funder types: Industry

Identifiers

NCT01513759

EKOS 09

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

EkoSonic® Endovascular System

Experimental group

Description:

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.

Treatment:

Drug: recombinant tissue plasminogen activator

Device: EKOS EkoSonic Endovascular System