CClinicalTrials.gg
Status unknownNCT02926742SPEEKUpdated Oct 6, 2016

Submassive Pulmonary Embolism Experience With EKOS

An observational study in Thrombolytic Therapy, Thrombolysis and Mechanical Thrombolysis, sponsored by Krishna Mannava, MD, FACS, RPVI. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-10-06.

Sponsored by Krishna Mannava, MD, FACS, RPVI · Observational

The sponsor has not verified this record recently (last verified Oct 2016), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

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

Read the 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.

02

Conditions studied

  • Thrombolytic Therapy
  • Thrombolysis
  • Mechanical Thrombolysis
  • Pulmonary Embolism

Keywords

  • Thrombolysis
  • Ultrasound Thrombolysis
  • Pulmonary Embolism
  • Saddle PE
  • Submassive PE
  • Massive PE
  • Bilateral PE
03

In context

Pulmonary Embolism

739 studies on the registry are indexed under Pulmonary Embolism; 159 are open to participants now.

This study's planned enrollment of 50 is below the median of 392 across 324 observational studies indexed under Pulmonary Embolism.

Browse Pulmonary Embolism studies →

Lead sponsor

This is the only study on the registry with Krishna Mannava, MD, FACS, RPVI as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Hospital setting. Volunteers meeting the inclusion/ exclusion criteria who are patients of Fairfield Medical Center located in Lancaster, Oho

Inclusion criteria

  1. Acute symptomatic PE confirmed by CT, with filling defect in at least one main or segmental 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 to give 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 > 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)..

Exclusion criteria

Exclusion Criteria:

  1. Stroke or transient ischemic attack (TIA), head trauma, or other active intracranial or 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 of study 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 active cardiopulmonary 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 to inclusion in the study
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Interventions

  • DeviceEkoSonic Endovascular System

    Ultrasound catheter-directed thrombolysis.

06

What researchers measure

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

    Time frame: 48 hours post catheter removal

07

Study locations

1 of 1 sites recruiting
  • Fairfield Medical Center
    Lancaster, Ohio 43130, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — De-identified individual study participant data will be made available 6 months after study completion. This data to include all primary and secondary outcome measures.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 6, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02926742
Lead sponsor
Krishna Mannava, MD, FACS, RPVI
Collaborators
EKOS Corporation
Responsible party
Krishna Mannava, MD, FACS, RPVI (Krishna Mannava, MD, FACS, RPVI, Fairfield Medical Center) — Sponsor-investigator
First posted
Oct 6, 2016
Start date
Feb 2014
Primary completion
Feb 2017 (estimated)
Completion
Feb 2017 (estimated)
Last update
Oct 6, 2016

Study contacts

Lisa K Stevens, MSN
Contact
lisas@fmchealth.org
7406894426
Krishna Mannava, MD
Contact
drkmannava@fmchealth.org
740-687-6910
Lisa K Stevens, MSN
study director · Fairfield Medical Center
Krishna Mannava, MD
principal investigator · Fairfield Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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