Clinical trial NCT02159521: Treatment of Chronic Deep Vein Thrombosis (DVT) and Post-Thrombotic Syndrome (PTS) With the EkoSonic® Endovascular System
Official title: ACCElerated ThrombolySiS for Post-Thrombotic Syndrome Using the EKOS System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Deep Vein Thrombosis
Post-thrombotic Syndrome
Keywords: deep vein thrombosis
post-thrombotic syndrome
chronic deep vein thrombosis
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
Collaborators: name: EKOS Corporation
First posted: 2014-06-10
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Key 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.

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) 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.

Primary outcomes:
measure: Change From Baseline in Villalta Score at Day 30 Post-EkoSonic® Study Treatment Procedure
timeFrame: Baseline (within 30 days of treatment), Day 30
measure: Percentage of Segments of Limbs That Achieved at Least 4-Point Reduction From Baseline in Villalta Score at Day 30
timeFrame: Baseline (within 30 days of treatment), Day 30
measure: Change From Baseline in Blood Flow (Calculated by Time to Washout in the Affected Segment) at Post-Adjunctive Therapy
timeFrame: Baseline (Within 30 days of treatment), Day 0
measure: Number of Participants With Major Bleeding
timeFrame: From start of study drug infusion up to 72 hours
Secondary outcomes:
measure: Change From Baseline in Ouriel Score (Venous Volumetric Index [VVI]) at Post-Adjunctive Therapy
timeFrame: Baseline (Within 30 days of treatment), Day 0
measure: Number of Participants With at Least 5-Point Reduction From Baseline in Ouriel Score at Post-Adjunctive Therapy
timeFrame: Baseline (Within 30 days of treatment), Day 0
measure: Change From Baseline in Villalta Score at Days 90, 180, and 365 Post-EkoSonic® Study Treatment Procedure
timeFrame: Baseline (within 30 days of treatment), Days 90, 180, and 365
measure: Percentage of Segments of Limbs That Achieved at Least 4-Point Reduction From Baseline in Villalta Score at Days 90, 180, and 365
timeFrame: Baseline (within 30 days of treatment), Days 90, 180, and 365
measure: Percentage of Treated Veins Segments of Limbs With Absence of Re-Occlusion, as Documented by Duplex Imaging
timeFrame: Day 365
measure: Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Sub-Scale Score and Physical Component Score (PCS) at Days, 30, 90, 180, and 365
timeFrame: Baseline (within 30 days of treatment), Days 30, 90, 180, and 365
measure: Number of Treated Limbs With Shift From Baseline in Clinical Stages (Symptomatic and Asymptomatic) of Clinical, Etiologic, Anatomic, Pathophysiological (CEAP) Classification at Days 30, 90, 180, and 365
timeFrame: Baseline (within 30 days of treatment), Days 30, 90, 180, and 365
measure: Change From Baseline in Venous Insufficiency Epidemiological and Economic Study Quality of Life (VEINES-QOL) Score At Days 30, 90, 180, and 360
timeFrame: Baseline (within 30 days of treatment), Days 30, 90, 180, and 365
measure: Change From Baseline in Venous Clinical Severity Score (VCSS) in Study Leg at Days 30, 90, 180, and 365
timeFrame: Baseline (within 30 days of treatment), Days 30, 90, 180, and 365
measure: Number of Participants With PTS-induced Admission to an Emergency Room or Unplanned Visits to a Physician's Office or Hospitalization
timeFrame: From the time of the EkoSonic® procedure (Day 0) up to 365 days
measure: Time From Starting Initial Thrombolytic Infusion to Discharge From the Hospital
timeFrame: From the time of the EkoSonic® procedure (Day 0) up to 365 days
measure: Number of Participants Who Had Symptomatic PE During Hospitalization for Study Procedure
timeFrame: From starting the initial thrombolytic infusion (Day 0) through discharge from hospital (up to Day 38)
measure: Number of Participants Who Died Due to Any Cause
timeFrame: Baseline (within 30 days of treatment) up to Day 365
measure: Number of Participants Who Had Adverse Events (AEs), Related (to the Study Procedure/Device/Medications) AEs, and Serious Adverse Events (SAEs)
timeFrame: Baseline (within 30 days of treatment) up to Day 30
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Darien
country: United States
facility: Vascular Breakthroughs
state: Connecticut
city: Newark
country: United States
facility: Christiana Hospital
state: Delaware
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Atlanta
country: United States
facility: Piedmont Atlanta Hospital
state: Georgia
city: Macon
country: United States
facility: Medical Center of Central Georgia
state: Georgia
city: Louisville
country: United States
facility: University of Louisville Research Foundation
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Ann Arbor
country: United States
facility: University of Michigan Medical Center
state: Michigan
city: Lincoln
country: United States
facility: CHI Health St. Elizabeth
state: Nebraska
city: Teaneck
country: United States
facility: Holy Name Medical Center
state: New Jersey
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: New York
country: United States
facility: Weill Cornell Medical Center
state: New York
city: Canton
country: United States
facility: Aultman Hospital
state: Ohio
city: Lancaster
country: United States
facility: Fairfield Medical Center
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Dallas
country: United States
facility: DFW Vascular Group/ Methodist Dallas Medical Ctr
state: Texas
city: Sugar Land
country: United States
facility: Houston Methodist Sugar Land Hospital
state: Texas
city: Alexandria
country: United States
facility: Inova Alexandria Hospital
state: Virginia
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
Study officials:
affiliation: Wilmington DE
name: Mark Garcia, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.