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

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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
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Canton, Ohio 44710
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22 Bramhall St
Portland, Maine 04102
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
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1 Tampa General Cir
Tampa, Florida 33606
(813) 844-7000
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Alexandria, Virginia 22304
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Ann Arbor, Michigan 48109
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Atlanta, Georgia 31201
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Hackensack, New Jersey 07601
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Indianapolis, Indiana
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401 N Ewing St
Lancaster, Ohio 43130
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Fairfield Medical Center We are people you know offering care you trust. Serving more than...
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94 Old Short Hills Road
Livingston, New Jersey 07039
(973) 322-5000
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757 Westwood Plaza
Los Angeles, California 90024
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New Haven CT, Connecticut 06510
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Newark, Delaware 19718
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600 Gresham Dr
Norfolk, Virginia 23507
(757) 388-3000
Sentara Norfolk General Hospital Sentara Norfolk General Hospital is recognized as the number one ranked...
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Tampa, Florida 33613
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Teaneck, New Jersey 07666
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Tucson, Arizona 85718
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