Treatment of Chronic Deep Vein Thrombosis (DVT) and Post-Thrombotic Syndrome (PTS) With the EkoSonic Endovascular System



Status:Recruiting
Conditions:Cardiology, Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 75
Updated:4/2/2016
Start Date:June 2014
End Date:December 2016
Contact:Lynn G Allen, RN, MS
Email:ekosclinical@ekoscorp.com
Phone:425 415 3152

Use our guide to learn which trials are right for you!

ACCelerated ThrombolySiS for Post-Thrombotic Syndrome Using EKOS

To evaluate the efficacy of ultrasound accelerated thrombolysis using the EkoSonic®
Endovascular System with standard infusion of thrombolytic drug for post-thrombotic syndrome
and chronic venous occlusion.

The study is designed to evaluate the safety and efficacy of ultrasound accelerated
thrombolysis using the EkoSonic® Endovascular System with standard infusion of a
thrombolytic drug for PTS and chronic DVT. Clinical effectiveness will be evaluated using a
standard measure of severity of post-thrombotic syndrome over a year.

Key Inclusion criteria:

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

2. Proximal DVT (iliac vein, common femoral vein, deep femoral vein, femoral vein) that
was objectively diagnosed with duplex imaging and/or venography ≥ 6 months prior to
study screening.

3. Persistent chronic DVT causing restrictive flow, as confirmed by imaging, within 60
days prior to the study procedure.

4. Villalta score ≥8 for the affected limb within 30 days prior to the study procedure.

5. Failed a minimum of 3 consecutive months of conservative treatment (therapeutic
anticoagulation and compression stockings) according to the completed Adherence to
Conservative Treatment Form.

Key Exclusion Criteria:

1. Treated with mechanical thrombectomy within 2 weeks of the study thrombolysis
procedure.

2. Treated with thrombolysis drugs within 48 hours of the study thrombolytic procedure.

3. Life expectancy less than 1 year.

4. Body Mass Index (BMI) >40 kg/m2 or per Investigator's discretion subject is able
tolerate the procedure and be compliant with post-procedure increased physical
activity.

5. No flow in popliteal vein on duplex imaging

6. Isolated iliac vein only thrombus.

7. Thrombus extending ≥ 3 cm into the inferior vena cava (IVC). If central venous
occlusion, consider computed tomography (CT) or magnetic resonance venography (MRV).
For subjects with bilateral DVT, it is recommended that central imaging be performed
prior to treatment to evaluate the status of the IVC.

8. Active bleeding, recent (< 3 mo) gastrointestinal (GI) bleeding, active peptic ulcer,
severe liver dysfunction, bleeding diathesis.

9. Recent (< 3 mo) internal eye surgery or hemorrhagic retinopathy; recent (< 10 days)
major surgery, cataract surgery, trauma, cardiopulmonary resuscitation (CPR),
obstetrical delivery, or other invasive procedure.

10. History of stroke or intracranial/intraspinal bleed, tumor, vascular malformation,
aneurysm.

11. 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.

12. Hemoglobin < 9.0 mg/dl within 24 hours prior to the procedure

13. International normalized ratio (INR) ≥ 1.5 ng/dl within 24 hours prior to the
procedure

14. Platelet count < 100,000 cells/mm3 or >700,000 cells/mm3 within 24 hours prior to the
procedure.

15. Creatinine outside the normal range for the treating institution and considered
clinically significant by the Investigator.

16. Uncontrolled hypertension, defined as systolic > 175 mmHg and a diastolic > 110 mmHg.

17. Use of clopidogrel, ticlopidine, or other thienopyridine antiplatelet drug within 7
days of the study procedurei.

18. In the judgment of the clinician, the subject is at high risk for catastrophic
bleeding.
We found this trial at
20
sites
Atlanta, Georgia 31201
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
22 Bramhall St
Portland, Maine 04102
(207) 662-0111
Maine Medical Center One of the country's consistently highest rated hospitals is right in your...
?
mi
from
Portland, ME
Click here to add this to my saved trials
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
?
mi
from
Portland, OR
Click here to add this to my saved trials
1 Tampa General Cir
Tampa, Florida 33606
(813) 844-7000
Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Alexandria, Virginia 22304
?
mi
from
Alexandria, VA
Click here to add this to my saved trials
Ann Arbor, Michigan 48109
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Canton, Ohio 44710
?
mi
from
Canton, OH
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Hackensack, New Jersey 07601
?
mi
from
Hackensack, NJ
Click here to add this to my saved trials
Indianapolis, Indiana
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
401 N Ewing St
Lancaster, Ohio 43130
(740) 687-8000
Fairfield Medical Center We are people you know offering care you trust. Serving more than...
?
mi
from
Lancaster, OH
Click here to add this to my saved trials
94 Old Short Hills Road
Livingston, New Jersey 07039
(973) 322-5000
Saint Barnabas Medical Center As a Barnabas Health facility, Saint Barnabas Medical Center is committed...
?
mi
from
Livingston, NJ
Click here to add this to my saved trials
757 Westwood Plaza
Los Angeles, California 90024
(310) 825-9111
UCLA Medical Center Founded in 1955, UCLA Medical Center became Ronald Reagan UCLA Medical Center...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Louisville, KY
Click here to add this to my saved trials
New Haven CT, Connecticut 06510
?
mi
from
New Haven CT, CT
Click here to add this to my saved trials
Newark, Delaware 19718
?
mi
from
Newark, DE
Click here to add this to my saved trials
600 Gresham Dr
Norfolk, Virginia 23507
(757) 388-3000
Sentara Norfolk General Hospital Sentara Norfolk General Hospital is recognized as the number one ranked...
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
Tampa, Florida 33613
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Teaneck, New Jersey 07666
?
mi
from
Teaneck, NJ
Click here to add this to my saved trials
Tucson, Arizona 85718
?
mi
from
Tucson, AZ
Click here to add this to my saved trials