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OpenTrials
Completed

NCT Number: NCT01899339

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

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Spectrum Health Hospitals

Grand Rapids, Michigan, 49503, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

submassive PA treatment with Ekosonic endo device

Other

Ultra Sound energy along with tPA to treat submassive pulmonary embolism

Other names: Ekosonic Endovascular Device

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Corewell Health West

Other

Collaborators

  • EKOS Corporation

Registry information

Official study title

Submassive Pulmonary Embolism Treatment With Ultrasound-Accelerated Thrombolysis

Acronym: SPEAR

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Jul 15, 2013
Registry last updated
Jul 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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