Submassive and Massive Pulmonary Embolism Treatment With Ultrasound Accelerated Thrombolysis Therapy

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.

Conditions

• Pulmonary Embolism
• Acute Pulmonary Embolism
• Sub-massive Pulmonary Embolism
• Massive Pulmonary Embolism
• Pulmonary Thromboembolism

Interventions

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.

Sponsors & Collaborators

• EKOS Corporation

  collaborator INDUSTRY

• Boston Scientific Corporation

  lead INDUSTRY

Principal Investigators

• Narinder Bhalla, MD · Baptist Health

• William Kuo, MD · Stanford Hospital and Clinics

• Stephen K Liu, MD · Memorial Medical Center - Modesto

• Immad Sidiq, MD · Hartford Hospital

• Samuel Z Goldhaber, MD · Brigham and Women's

• Mark J Garcia, MD · Christiana Hospital

• Rohit Bhatheja, MD · AdventHealth

• Robert Kennedy, MD · Holmes Regional Medical Center

• Fakhir Elmasri, MD · Lakeland Regional Medical Center

• Barry S Weinstock, MD · Orlando Regional Medical Center

• Juan Ayerdi, MD · Medical Center of Central Georgia

• Nilesh Goswami, MD · Prairie Heart Institute - St.John's Hospital

• Kannan Natarajan, MD · St Vincent's Hospital

• Tod C Engelhardt, MD · East Jefferson General Hospital

• Mark Kumar, MD · Overlook Medical Center

• John Rundback, MD · Holy Name Hospital

• Jacob Cynamon, MD · Montefiore Medical Center

• Peter Soukas, MD · The Miriam Hospital

• Mohammad L Raja, MD · Providence Memorial Hospital - Sierra Vista Hospital

• Keith M Sterling, MD · Inova Alexandria

• John Gurley, MD · University of Kentucky

• Noah Jones, MD · Mt. Carmel East

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-06-07

Primary Completion

2013-02-17

Completion

2013-02-17

Countries

• United States

Study Locations