Submassive Pulmonary Embolism Experience With EKOS

Last updated: October 5, 2016
Sponsor: Krishna Mannava, MD, FACS, RPVI
Overall Status: Trial Status Unknown

Phase

N/A

Condition

Chest Pain

Claudication

Vascular Diseases

Treatment

N/A

Clinical Study ID

NCT02926742
FMCspeekEKOSstudy
  • Ages > 18
  • All Genders

Study Summary

This single site study evaluates the efficacy of ultrasound accelerated thrombolysis using EKOS Endovascular Device with a standard infusion of thrombolytics for treatment of PE

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Acute symptomatic PE confirmed by CT, with filling defect in at least one main orsegmental pulmonary artery.

  2. RV dysfunction as evidenced by RV/LV ratio > 0.9 on echo

  3. Ability to give informed consent or Legally Authorized Representative (LAR) is able togive consent

  4. PE symptom duration < 21 days

  5. Age >18 years

  6. And, a MBS baseline measurement above 3 plus at least one of the following: O2 sat < 90% RA, or inability to maintain a HR <100, or inability to maintain a Systolic Bp >

  7. Whichever measurement is chosen for inclusion criteria in addition to the MBSwill also be used in determination of therapeutic endpoint (i.e. O2 Sat., HR<100 or BP >100)..

Exclusion

Exclusion Criteria:

  1. Stroke or transient ischemic attack (TIA), head trauma, or other active intracranialor intraspinal disease within one year

  2. Recent (within one month) or active bleeding from a major organ

  3. Hemoglobin (Hgb) < 8.0

  4. Platelets < 60 thousand/µL

  5. Major surgery within seven days

  6. Clinician deems high-risk for catastrophic bleeding

  7. History of heparin-induced thrombocytopenia (HIT)

  8. Pregnancy

  9. Catheter-based pharmacomechanical treatment for pulmonary embolism within 3 days ofstudy enrollment

  10. Systolic blood pressure less than 80 mm Hg despite vasopressor or inotropic support

  11. Cardiac arrest (including pulseless electrical activity and asystole) requiring activecardiopulmonary resuscitation (CPR)

  12. Evidence of irreversible neurological compromise

  13. Life expectancy < 30 days

  14. Use of thrombolytics or glycoprotein IIb/IIIa antagonists within 3 days prior toinclusion in the study

Study Design

Total Participants: 50
Study Start date:
February 01, 2014
Estimated Completion Date:
February 28, 2017

Study Description

Previous clinical trials examining thrombolytics used to treat Acute Submassive PE, many times will use fixed dose and duration. Little research has been conducted on the physiologic implication of resolution of symptoms. It seems reasonable, that symptomatic relief results from some degree of hemodynamic normalization. This study will seek to examine the extent to which the hemodynamic impairment is normalized from a thrombolytic treatment protocol with an endpoint of therapy determined as resolution of presenting symptoms. Treatment plans will utilize the MBS (Modified Borg Scale) score to help evaluate and measure outcome-based care, quantifying shortness of breath.

Connect with a study center

  • Fairfield Medical Center

    Lancaster, Ohio 43130
    United States

    Active - Recruiting

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