Long Term Effects of Treating Submassive Pulmonary Embolism With Ultra-sound Accelerated Thrombolysis (SPEAR)

July 14, 2023 updated by: Michael F Knox, MD, Spectrum Health Hospitals

Submassive Pulmonary Embolism Treatment With Ultrasound-Accelerated Thrombolysis

Patients with Submassive Pulmonary Embolism treated with ultra-sound therapy will have an improved right ventricular function 72 hours post treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Spectrum Health Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

All patient presenting to the Emergency Department with submassive pulmonary hypertension over the age of 18.

Description

Inclusion Criteria:

  • Patients with acute (< or = 14 days)symptomatic pulmonary embolism by CT Angiogram of the thorax with embolus involving at least one main or lower lobe pulmonary artery and RV:LV ratio > 0.9

Exclusion Criteria:

  • age > 80
  • Recent thrombolytic therapy (with in 4 days)
  • Active bleeding or know bleeding diathesis
  • Known coagulopathy (including treatment with vitamin K antagonists) INR > 3 and/or PTT > 50
  • Thrombocytopenia (PLT cound < 100,000)
  • History of any intracranial or intraspinal surgery, trauma or bleed
  • Intracranial neoplasms, AVM, or aneurysm
  • Recent (< 1 month) GI bleed
  • Recent (< 3 months) internal eye surgery or hemorrhagic retinopathy
  • Recent (< 7 days) major surgery, trauma, or obstetrical delivery
  • Renal insufficiency with eGFR < 45 ml/min
  • Known allergy, hypersensitivity, or thrombocytopenia from heparin or tPA
  • Hemodynamic instability defined as need for cardiopulmonay resuscitation, Systolic BP > 90 mm Hg for > 15 min or need for pressor agents to maintain BP > 90.
  • Severe Hypertension (sustained systolic > 180 mm Hg or diastolic > 90 mm Hg.
  • Pregnant patients
  • known right to left shunt
  • Large (>10 mm)intracardiac thrombus
  • Use of thrombolytics or glycoprotein IIb/IIIa antangonists within 3 days of inclusion.
  • Life expectancy < 30 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
pulmonary embolism
patients with submassive pulmonary embolism
Other: submassive PA treatment with Ekosonic endo device
Ultra Sound energy along with tPA to treat submassive pulmonary embolism
Other Names:
  • Ekosonic Endovascular Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Right Ventricular:Left Ventricular ratio
Time Frame: baseline to 72 hours post
Treatment will show improved Right Ventricular:Left Ventricular ratio at 72 hours post.
baseline to 72 hours post

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recurrent pulmonary embolism
Time Frame: 30 days post procedure
Will assess whether a recurrent Pulmonary Embolism has happened at 30 day post procedure or earlier
30 days post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spectrum Health Hospitals

Collaborators

EKOS Corporation

Investigators

  • Principal Investigator: Michael Knox, MD, Spectrum Health Hosptials and ARS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

February 1, 2019

Study Completion (Actual)

February 1, 2019

Study Registration Dates

First Submitted

July 10, 2013

First Submitted That Met QC Criteria

July 12, 2013

First Posted (Estimated)

July 15, 2013

Study Record Updates

Last Update Posted (Actual)

July 18, 2023

Last Update Submitted That Met QC Criteria

July 14, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-069
  • Ekos (Other Identifier: spectrum health)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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