Submassive Pulmonary Embolism Experience With EKOS

• Conditions: Pulmonary Embolism; Thrombolytic Therapy; Thrombolysis; Mechanical Thrombolysis

• Registration Number: NCT02926742
• Lead Sponsor: Krishna Mannava, MD, FACS, RPVI

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

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 Timeline

• Study Start: 2014-02
• Status Verified: 2016-10
• Study First Submitted: 2016-10-05
• Study First Submitted QC: 2016-10-05
• Last Update Submitted: 2016-10-05
• Study First Posted: 2016-10-06
• Last Update Posted: 2016-10-06
• Primary Completion: 2017-02
• Study Completion: 2017-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Fairfield Medical Center; 🇺🇸 Lancaster, Ohio, United States