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

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ClinicalTrials.gov Identifier: NCT02159521
Recruitment Status : Active, not recruiting
First Posted : June 10, 2014
Last Update Posted : March 21, 2017
Sponsor:
Collaborator:
BTG International Inc.
Information provided by (Responsible Party):
EKOS Corporation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Deep Vein Thrombosis Post-thrombotic Syndrome Device: EkoSonic Endovascular System Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 113 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ACCelerated ThrombolySiS for Post-Thrombotic Syndrome Using EKOS
Actual Study Start Date : July 10, 2014
Actual Primary Completion Date : December 30, 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: prospective, single-arm
EkoSonic endovascular system in the treatment of chronic deep vein thrombosis
Device: EkoSonic Endovascular System
ultrasound catheter directed thrombolysis




Primary Outcome Measures :
  1. Change in Villalta Score [ Time Frame: Baseline through 30 days ]
    Clinical efficacy will be evaluated using the Villalta score at Baseline compared to 30 days Post-EkoSonic® Study Treatment Procedure.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 procedure.
  18. In the judgment of the clinician, the subject is at high risk for catastrophic bleeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02159521


  Show 22 Study Locations
Sponsors and Collaborators
EKOS Corporation
BTG International Inc.
Investigators
Principal Investigator: Mark Garcia, MD Wilmington DE

Additional Information:
Responsible Party: EKOS Corporation
ClinicalTrials.gov Identifier: NCT02159521     History of Changes
Other Study ID Numbers: EKOS-11
First Posted: June 10, 2014    Key Record Dates
Last Update Posted: March 21, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by EKOS Corporation:
deep vein thrombosis
post-thrombotic syndrome
chronic deep vein thrombosis

Additional relevant MeSH terms:
Syndrome
Thrombosis
Venous Thrombosis
Postthrombotic Syndrome
Postphlebitic Syndrome
Disease
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Venous Insufficiency
Phlebitis
Peripheral Vascular Diseases