SPEEK: Submassive Pulmonary Embolism Experience With EKOS

Sponsor

Krishna Mannava, MD, FACS, RPVI (Other)

Overall Status

Unknown status

CT.gov ID

NCT02926742

Collaborator

EKOS Corporation (Industry)

Enrollment

Location

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Thrombolytic Therapy Thrombolysis Mechanical Thrombolysis Pulmonary Embolism	Device: EkoSonic Endovascular System

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Submassive Pulmonary Embolism Experience With EKOS

Study Start Date :

Feb 1, 2014

Anticipated Primary Completion Date :

Feb 1, 2017

Anticipated Study Completion Date :

Feb 1, 2017

Outcome Measures

Primary Outcome Measures

Reduction of RV dysfunction [48 hours post catheter removal]
Reduction of RV dysfunction as evidenced by a reduction in RVSP and or a reduction in RV/LV ratio measured by echo at baseline and again at 48 ±6 hours post EKOS catheter removal

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 >
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)..

Exclusion Criteria:

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