Recruiting

EKOS

Sponsor:

Krishna Mannava, MD, FACS, RPVI

Code:

NCT02926742

Conditions

Thrombolytic Therapy

Thrombolysis

Mechanical Thrombolysis

Pulmonary Embolism

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

EkoSonic Endovascular System

Study Details

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

Conditions

Thrombolytic Therapy

Thrombolysis

Mechanical Thrombolysis

Pulmonary Embolism

Study ID

NCT02926742

Start date

Feb, 2014

Status verified date

Oct, 2016

Completion date

Feb, 2017

Anticipated

Primary completion date

Feb, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Interventions

EkoSonic Endovascular System

Ultrasound catheter-directed thrombolysis.

Primary outcome measure

  • Reduction of RV dysfunction [ Time Frame: 48 hours post catheter removal ]

Central Contacts and Locations

Central contacts

Locations

Fairfield Medical Center

Recruiting

Lancaster, Ohio, United States, 43130

Contacts

More Information

Sponsor

Krishna Mannava, MD, FACS, RPVI

Last update posted

Oct 6, 2016

Last verified

Oct, 2016

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Krishna Mannava, MD, FACS, RPVI on 2016-10-06.