Submassive Pulmonary Embolism Experience With EKOS
SPEEK
1 other identifier
observational
50
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2014
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 5, 2016
CompletedFirst Posted
Study publicly available on registry
October 6, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedOctober 6, 2016
October 1, 2016
3 years
October 5, 2016
October 5, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction of RV dysfunction
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
48 hours post catheter removal
Interventions
Ultrasound catheter-directed thrombolysis.
Eligibility Criteria
Hospital setting. Volunteers meeting the inclusion/ exclusion criteria who are patients of Fairfield Medical Center located in Lancaster, Oho
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
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Krishna Mannava, MD, FACS, RPVIlead
- EKOS Corporationcollaborator
Study Sites (1)
Fairfield Medical Center
Lancaster, Ohio, 43130, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Lisa K Stevens, MSN
Fairfield Medical Center
- PRINCIPAL INVESTIGATOR
Krishna Mannava, MD
Fairfield Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Krishna Mannava, MD, FACS, RPVI
Study Record Dates
First Submitted
October 5, 2016
First Posted
October 6, 2016
Study Start
February 1, 2014
Primary Completion
February 1, 2017
Study Completion
February 1, 2017
Last Updated
October 6, 2016
Record last verified: 2016-10