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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02926742
Other study ID # FMCspeekEKOSstudy
Secondary ID
Status Recruiting
Phase N/A
First received October 5, 2016
Last updated October 5, 2016
Start date February 2014
Est. completion date February 2017

Study information

Verified date October 2016
Source Fairfield Medical Center
Contact Lisa K Stevens, MSN
Phone 7406894426
Email lisas@fmchealth.org
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date February 2017
Est. primary completion date February 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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:

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Intervention

Device:
EkoSonic Endovascular System
Ultrasound catheter-directed thrombolysis.

Locations

Country Name City State
United States Fairfield Medical Center Lancaster Ohio

Sponsors (2)

Lead Sponsor Collaborator
Krishna Mannava, MD, FACS, RPVI EKOS Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
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