Submassive Pulmonary Embolism Experience With EKOS

Status unconfirmed

Conditions studied: Thrombolytic Therapy, Thrombolysis, Mechanical Thrombolysis, Pulmonary Embolism

In brief

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

Key facts

Study ID

NCT02926742

Run by

Krishna Mannava, MD, FACS, RPVI

People needed

50

Starts

2014-02-01

Expected to finish

2017-02-01

Last updated by the study team

2016-10-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Acute symptomatic PE confirmed by CT, with filling defect in at least one main or segmental pulmonary artery.
• RV dysfunction as evidenced by RV/LV ratio > 0.9 on echo
• Ability to give informed consent or Legally Authorized Representative (LAR) is able to give consent
• PE symptom duration < 21 days
• Age >18 years
• 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 > 100. Whichever measurement is chosen for inclusion criteria in addition to the MBS will also be used in determination of therapeutic endpoint (i.e. O2 Sat., HR<100 or BP >100)..

You may not qualify if…

• Stroke or transient ischemic attack (TIA), head trauma, or other active intracranial or intraspinal disease within one year
• Recent (within one month) or active bleeding from a major organ
• Hemoglobin (Hgb) < 8.0
• Platelets < 60 thousand/µL
• Major surgery within seven days
• Clinician deems high-risk for catastrophic bleeding
• History of heparin-induced thrombocytopenia (HIT)
• Pregnancy
• Catheter-based pharmacomechanical treatment for pulmonary embolism within 3 days of study enrollment
• Systolic blood pressure less than 80 mm Hg despite vasopressor or inotropic support
• Cardiac arrest (including pulseless electrical activity and asystole) requiring active cardiopulmonary resuscitation (CPR)
• Evidence of irreversible neurological compromise
• Life expectancy < 30 days
• Use of thrombolytics or glycoprotein IIb/IIIa antagonists within 3 days prior to inclusion in the study

Where it is running

• Fairfield Medical Center — Lancaster, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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