Optimum Duration of Acoustic Pulse Thrombolysis Procedure in Acute Pulmonary Embolism



Status:Recruiting
Conditions:Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 75
Updated:4/21/2016
Start Date:April 2015
End Date:June 2017
Contact:Lynn G Allen, RN, MS
Email:lynn.allen@ekoscorp.com
Phone:425 415 3152

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Study of the Optimum Duration of Acoustic Pulse Thrombolysis Procedure in the Treatment of Acute Submassive Pulmonary Embolism

The objective of the study is to determine the optimum dose of thrombolytic and duration of
the ultrasound procedure as a treatment for acute submassive 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 -
We found this trial at
16
sites
Wynnewood, Pennsylvania 19096
Principal Investigator: Lee Greenspon, M.D.
Phone: 610-642-3796
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: Pete Fong, M.D.
Phone: 615-343-9071
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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1968 Peachtree Rd NW
Atlanta, Georgia 30309
(404) 605-5000
Principal Investigator: Charles Ross, M.D.
Phone: 404-605-3561
Piedmont Hospital For more than a century, Piedmont Healthcare has been a recognized leader in...
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Augusta, Georgia 30901
Principal Investigator: Houman Tamaddon, M.D.
Phone: 706-724-3473
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Beverly Hills, California 90211
Principal Investigator: Victor Tapson, M.D.
Phone: 310-248-7197
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Columbus, Ohio 43213
Principal Investigator: Noah Jones, MD
Phone: 614-546-4327
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Columbus, OH
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Detroit, Michigan 48201
Principal Investigator: Mahir Elder, M.D.
Phone: 313-745-9224
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Erie, Pennsylvania 16507
Principal Investigator: Robert Maholic, DO
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Grand Rapids, Michigan 49503
Principal Investigator: Michael Knox, M.D.
Phone: 616-391-1963
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Indianapolis, Indiana 46290
Principal Investigator: Kannan Natarajan, MD
Phone: 317-338-6152
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Indianapolis, IN
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Louisville, Kentucky 40202
Principal Investigator: Amir Piracha
Phone: 502-540-3409
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Metairie, Louisiana 70006
Principal Investigator: Tod Engelhardt, M.D.
Phone: 504-503-5368
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273 Bleecker Street
New York, New York 10065
Phone: 212-746-9748
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New York, NY
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Richmond, Texas 77469
Principal Investigator: Uttam Tripathy, M.D.
Phone: 281-276-3053
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Tallahassee, Florida 32308
Principal Investigator: John Katopodis, MD
Phone: 850-431-5024
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Tampa, Florida 33613
Principal Investigator: Marques Vasco, M.D.
Phone: 813-615-0728
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