Submassive Pulmonary Embolism Experience With EKOS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-02-28

Study Completion Date

2017-02-28

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Thrombolytic Therapy Thrombolysis Mechanical Thrombolysis Pulmonary Embolism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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EkoSonic Endovascular System

Ultrasound catheter-directed thrombolysis.

Intervention Type DEVICE

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No