HI-PEITHO

Summary

This study focuses on individuals who have been diagnosed with pulmonary embolism (having a blood clot in one or both of the lungs). The purpose of the study is to investigate whether treatment with anticoagulation (blood thinner) medications in combination with the EkoSonic Endovascular device and a dose of a clot-dissolving drug can reduce the risk of death and other serious problems when compared to anticoagulation medication alone. The EkoSonic Endovascular System provides electrical energy and catheters to deliver clot-dissolving drug to the clot. Measurements will also be taken to observe overall health and quality of life for one year after treatment. Participants will be randomly assigned to receive either anticoagulant medication alone, or treatment with anticoagulation medications in combination with the EkoSonic Endovascular device and clot-dissolving drug. The device, procedure and treatment with anticoagulation medication are not considered to be investigational.


Inclusion Criteria

  • Age 18-80 years, inclusive
  • Objectively confirmed acute PE, based on computed tomography pulmonary angiography (CTPA) showing a filling defect in at least one main or proximal lobar pulmonary artery
  • Elevated risk of early death/hemodynamic collapse, indicated by at least two of the following new-onset clinical criteria:
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Study Location(s)

Beverly

More about this Clinical Trial

Full Title

A randomized trial of ultrasound-facilitated, catheter-directed, thrombolysis versus anticoagulation for acute intermediate-high risk pulmonary embolism: The higher-risk pulmonary embolism thrombolysis study

Details
Disease Type/Condition

Pulmonary Vascular Disease

Principal Investigator

Friedman, Oren

Age Group

Adult

Phase

N/A

IRB Number

STUDY00001589

ClinicalTrials.gov ID

NCT04790370

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?

Details
Disease Type/Condition

Pulmonary Vascular Disease

Principal Investigator

Friedman, Oren

Age Group

Adult

Phase

N/A

IRB Number

S2479-HI-PEITHO

ClinicalTrials.gov ID

NCT04790370

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?