Trial Search Results

A Prospective, Single-arm, Multi-center Trial of EkoSonic® Endovascular System and Activase for Treatment of Acute Pulmonary Embolism (PE).

The purpose of this study is to determine if the EKOS EkoSonic® Endovascular Device when used in conjunction with recombinant t-PA as a treatment for acute pulmonary embolism (PE) will decrease the ratio of RV to LV diameter within 48 ± 6 hours in patients with massive or submassive PE.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

EKOS Corporation

Intervention(s):

  • Drug: recombinant tissue plasminogen activator
  • Device: EKOS EkoSonic Endovascular System
  • Drug: Alteplase

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - CT evidence of proximal PE (filling defect in at least one main or segmental pulmonary
   artery) AND

   - Age ≥ 18 years AND

   - PE symptom duration ≤14 days AND

   - Informed consent can be obtained from subject or Legally Authorized Representative
   (LAR) AND

   - Massive PE (syncope, systemic arterial hypotension, cardiogenic shock, or resuscitated
   cardiac arrest) OR

   - Submassive PE (RV diameter-to-LV diameter ≥ 0.9 on contrast-enhanced chest CT)

Exclusion Criteria:

   - Stroke or transient ischemic attack (TIA), head trauma, or other active intracranial
   or intraspinal disease within one year

   - Recent (within one month) or active bleeding from a major organ

   - Hematocrit < 30%

   - Platelets < 100 thousand/μL

   - INR > 3

   - aPTT > 50 seconds on no anticoagulants

   - Major surgery within seven days

   - Serum creatinine > 2 mg/dL

   - Clinician deems high-risk for catastrophic bleeding

   - History of heparin-induced thrombocytopenia (HIT)

   - Pregnancy

   - Catheter-based pharmacomechanical treatment for pulmonary embolism within 3 days of
   study enrollment

   - Systolic blood pressure less than 80 mm Hg despite vasopressor or inotropic support

   - Cardiac arrest (including pulseless electrical activity and asystole) requiring active
   cardiopulmonary resuscitation (CPR)

   - Evidence of irreversible neurological compromise

   - Life expectancy < 30 days

   - Use of thrombolytics or glycoprotein IIb/IIIa antagonists within 3 days prior to
   inclusion in the study

   - Previous enrollment in the SEATTLE study

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
William Kuo, MD
Recruiting