Optimum Duration of Acoustic Pulse Thrombolysis Procedure in Acute Pulmonary Embolism

Subjects with pulmonary embolism with a RV/LV >0.9 and hemodynamically stable who meet all
eligibility criteria and sign informed consent will be randomized to one of 4 treatment
groups (see below). 48 hours after the start of treatment, a repeat CTA will be obtained and
a RV/LV obtained. Thereafter, subjects will be followed for 12 months and an echocardiogram
obtained at each clinic visit. Subjects will be monitored for occurrence of repeat PE and
other serious adverse events.

Inclusion Criteria:

1. Male or female ≥ 18 years of age and ≤ 75 years of age

2. CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonary
artery)

3. PE symptom duration ≤14 days

4. Submassive PE: RV/LV diameter ≥ 0.9 from CTA and hemodynamically stable

5. Must be treated within 48 hours of diagnosis of PE by CTA

6. Signed Informed consent obtained from subject or Legally Authorized Representative -

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. Major surgery within seven days of screening for study enrollment

4. Clinician deems the subject high-risk for catastrophic bleeding

5. History of heparin-induced thrombocytopenia (HIT)

6. Catheter-based pharmacomechanical treatment for PE within 3 days of study enrollment

7. Systolic blood pressure (SBP) less than 90 mm Hg and/or use of vasopressors

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

9. Evidence of irreversible neurological compromise

10. Life expectancy < one year

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

12. Out-of-Range Laboratory Values: Hematocrit < 30%, Platelets < 100 thousand/μL, INR >
3,

13. Creatinine outside the normal range for the treating institution

14. Subject is pregnant (positive pregnancy test; women of childbearing capacity must be
tested) or breast feeding

15. Active cancer (metastatic, progressive, or treated within the last 6 months).
Exception: subjects with non-melanoma primary skin cancers are eligible to
participate in the study

16. Known allergy, hypersensitivity, or thrombocytopenia from heparin, r-tPA, or
iodinated contrast except for mild-moderate contrast allergies for which steroid
pre-medication can be used -