Submassive Pulmonary Embolism Experience With EKOS

Pulmonary Embolism Clinical Trial

— SPEEK  

Official title:

Submassive Pulmonary Embolism Experience With EKOS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02926742
• Other study ID #: FMCspeekEKOSstudy
• 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

Related Conditions & MeSH terms

• Embolism
• Mechanical Thrombolysis
• Pulmonary Embolism
• Thrombolysis
• Thrombolytic Therapy

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