Long Term Effects of Treating Submassive Pulmonary Embolism With Ultra-sound Accelerated Thrombolysis
NCT ID: NCT01899339
Last Updated: 2023-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
25 participants
OBSERVATIONAL
2013-05-31
2019-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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pulmonary embolism
patients with submassive pulmonary embolism
submassive PA treatment with Ekosonic endo device
Ultra Sound energy along with tPA to treat submassive pulmonary embolism
Interventions
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submassive PA treatment with Ekosonic endo device
Ultra Sound energy along with tPA to treat submassive pulmonary embolism
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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EKOS Corporation
INDUSTRY
Spectrum Health Hospitals
OTHER
Responsible Party
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Michael F Knox, MD
Medical Doctor
Principal Investigators
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Michael Knox, MD
Role: PRINCIPAL_INVESTIGATOR
Spectrum Health Hosptials and ARS
Locations
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Spectrum Health Hospitals
Grand Rapids, Michigan, United States
Countries
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Other Identifiers
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Ekos
Identifier Type: OTHER
Identifier Source: secondary_id
2013-069
Identifier Type: -
Identifier Source: org_study_id
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