NCT01899339

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 15, 2013

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

July 18, 2023

Status Verified

July 1, 2023

Enrollment Period

5.8 years

First QC Date

July 10, 2013

Last Update Submit

July 14, 2023

Conditions

Submassive Pulmonary Embolism

Keywords

submassive pulmonary embolismUltrasonic energyEkosonic Endovascular DeviceRV:LV function after Pulmonary Embolism

Outcome Measures

Primary Outcomes (1)

  • Change in Right Ventricular:Left Ventricular ratio

    Treatment will show improved Right Ventricular:Left Ventricular ratio at 72 hours post.

    baseline to 72 hours post

Secondary Outcomes (1)

  • recurrent pulmonary embolism

    30 days post procedure

Study Arms (1)

pulmonary embolism

patients with submassive pulmonary embolism

Other: submassive PA treatment with Ekosonic endo device

Interventions

submassive PA treatment with Ekosonic endo deviceOTHER

Ultra Sound energy along with tPA to treat submassive pulmonary embolism

Also known as: Ekosonic Endovascular Device
pulmonary embolism

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spectrum Health Hospitals

Grand Rapids, Michigan, 49503, United States

Location

Study Officials

  • Michael Knox, MD

    Spectrum Health Hosptials and ARS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

July 10, 2013

First Posted

July 15, 2013

Study Start

May 1, 2013

Primary Completion

February 1, 2019

Study Completion

February 1, 2019

Last Updated

July 18, 2023

Record last verified: 2023-07

Locations

US(1)