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

NCT ID: NCT02159521

Last Updated: 2021-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-10
• Study Completion Date: 2017-11-30

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 from chronic venous occlusion.

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.

Conditions

Deep Vein Thrombosis; Post-thrombotic Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EkoSonic® Endovascular System

Thrombolytic infusion (Alteplase), at an infusion rate of 0.5-1.0 milligrams/hour (mg/hr) will be delivered to the participants with chronic lower extremity venous obstruction after DVT and PTS through the EkoSonic® Endovascular System for at least 12 hours and overnight as needed up to a maximum of 48 hrs. The alteplase dose could be adjusted per investigator discretion, but not to be exceeded 1 mg/hr or a total dose of 48 mg.

Group Type: EXPERIMENTAL

EkoSonic® Endovascular System

Intervention Type: DEVICE

Alteplase

Intervention Type: BIOLOGICAL

Recombinant tissue plasminogen activator

Interventions

EkoSonic® Endovascular System

Intervention Type: DEVICE

Alteplase

Recombinant tissue plasminogen activator

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Male or female greater than or equal to (≥) 18 years of age and less than or equal to (≤) 75 years of age.

2. Proximal DVT (iliac vein, common femoral vein, deep femoral vein, and 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.

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) greater than (>) 40 kilograms/square meter (kg/m^2) or per Investigator's discretion participant 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 centimeters (cm) into the inferior vena cava (IVC). If central venous occlusion, consider computed tomography (CT) or magnetic resonance venography (MRV). For participants 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 months) gastrointestinal (GI) bleeding, active peptic ulcer, severe liver dysfunction, and bleeding diathesis.

9. Recent (<3 months) 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, or aneurysm.

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

12. Hemoglobin <9.0 milligrams/deciliter (mg/dL) within 24 hours prior to the procedure

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

14. Platelet count <100,000 cells/cubic millimeter (cells/mm^3) or >700,000 cells/mm^3 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 millimeters of mercury (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 participant is at high risk for catastrophic bleeding.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EKOS Corporation

INDUSTRY

Sponsor Role: collaborator

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Garcia, MD

Role: PRINCIPAL_INVESTIGATOR

Wilmington DE

Locations

UCLA Medical Center

Los Angeles, California, United States

University of Colorado Hospital

Aurora, Colorado, United States

Vascular Breakthroughs

Darien, Connecticut, United States

Christiana Hospital

Newark, Delaware, United States

Tampa General Hospital

Tampa, Florida, United States

Piedmont Atlanta Hospital

Atlanta, Georgia, United States

Medical Center of Central Georgia

Macon, Georgia, United States

University of Louisville Research Foundation

Louisville, Kentucky, United States

Ochsner Medical Center

New Orleans, Louisiana, United States

Maine Medical Center

Portland, Maine, United States

University of Michigan Medical Center

Ann Arbor, Michigan, United States

CHI Health St. Elizabeth

Lincoln, Nebraska, United States

Holy Name Medical Center

Teaneck, New Jersey, United States

NYU Langone Medical Center

New York, New York, United States

Weill Cornell Medical Center

New York, New York, United States

Aultman Hospital

Canton, Ohio, United States

Fairfield Medical Center

Lancaster, Ohio, United States

Oregon Health & Science University

Portland, Oregon, United States

DFW Vascular Group/ Methodist Dallas Medical Ctr

Dallas, Texas, United States

Houston Methodist Sugar Land Hospital

Sugar Land, Texas, United States

Inova Alexandria Hospital

Alexandria, Virginia, United States

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

Countries

United States

References

Garcia MJ, Sterling KM, Kahn SR, Comerota AJ, Jaff MR, Ouriel K, Weinberg I; ACCESS PTS Investigators. Ultrasound-Accelerated Thrombolysis and Venoplasty for the Treatment of the Postthrombotic Syndrome: Results of the ACCESS PTS Study. J Am Heart Assoc. 2020 Feb 4;9(3):e013398. doi: 10.1161/JAHA.119.013398. Epub 2020 Jan 25.

Reference Type: DERIVED

PMID: 31983322 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://www.chronicdvtstudy.com

study website

http://www.ekoscorp.com

EKOS company website

Other Identifiers

EKOS-11

Identifier Type: -

Identifier Source: org_study_id