Phase 4
N=81
Treatment of Chronic Deep Vein Thrombosis (DVT) and Post-Thrombotic Syndrome (PTS) With the EkoSonic® Endovascular System
Deep Vein Thrombosis · Post-thrombotic Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT02159521 ↗Enrolled (actual)
81
Serious AEs
20.5%
Results posted
Feb 2020
Primary outcome: Primary: Change From Baseline in Villalta Score at Day 30 Post-EkoSonic® Study Treatment Procedure — 15.5; -5.9 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- EkoSonic® Endovascular System (Device); Alteplase (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston Scientific Corporation
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Villalta Score at Day 30 Post-EkoSonic® Study Treatment Procedure |
15.5; -5.9 | — |
| PRIMARY Percentage of Segments of Limbs That Achieved at Least 4-Point Reduction From Baseline in Villalta Score at Day 30 |
64 | — |
| PRIMARY Change From Baseline in Blood Flow (Calculated by Time to Washout in the Affected Segment) at Post-Adjunctive Therapy |
4.39; -2.17; 3.28; -0.96 | — |
| PRIMARY Number of Participants With Major Bleeding |
1 | — |
| SECONDARY Change From Baseline in Ouriel Score (Venous Volumetric Index [VVI]) at Post-Adjunctive Therapy |
10.58; 6.88 | — |
| SECONDARY Number of Participants With at Least 5-Point Reduction From Baseline in Ouriel Score at Post-Adjunctive Therapy |
— | — |
| SECONDARY Change From Baseline in Villalta Score at Days 90, 180, and 365 Post-EkoSonic® Study Treatment Procedure |
15.5; -6.9; -7.8; -8.2 | — |
| SECONDARY Percentage of Segments of Limbs That Achieved at Least 4-Point Reduction From Baseline in Villalta Score at Days 90, 180, and 365 |
66; 74; 74 | — |
| SECONDARY Percentage of Treated Veins Segments of Limbs With Absence of Re-Occlusion, as Documented by Duplex Imaging |
100; 100; 100; 100; 97.9; 100 | — |
| SECONDARY 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 |
48.4; 9.5; 14.0; 15.1; 13.9; 47.2 | — |
| SECONDARY 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 |
67; 12; 56; 19; 45; 25 | — |
| SECONDARY Change From Baseline in Venous Insufficiency Epidemiological and Economic Study Quality of Life (VEINES-QOL) Score At Days 30, 90, 180, and 360 |
61.1; 10.3; 16.3; 18.9; 18.7 | — |
| SECONDARY Change From Baseline in Venous Clinical Severity Score (VCSS) in Study Leg at Days 30, 90, 180, and 365 |
12.0; -3.8; -4.5; -5.2; -5.7 | — |
| SECONDARY Number of Participants With PTS-induced Admission to an Emergency Room or Unplanned Visits to a Physician's Office or Hospitalization |
24; 13; 18; 8 | — |
| SECONDARY Time From Starting Initial Thrombolytic Infusion to Discharge From the Hospital |
2 | — |
| SECONDARY Number of Participants Who Had Symptomatic PE During Hospitalization for Study Procedure |
— | — |
| SECONDARY Number of Participants Who Died Due to Any Cause |
1 | — |
| SECONDARY Number of Participants Who Had Adverse Events (AEs), Related (to the Study Procedure/Device/Medications) AEs, and Serious Adverse Events (SAEs) |
34; 15; 3; 8; 15; 3 | — |
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.
Eligibility Criteria
Key Inclusion criteria
- Male or female greater than or equal to (≥) 18 years of age and less than or equal to (≤) 75 years of age.
- 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.
- Persistent chronic DVT causing restrictive flow, as confirmed by imaging, within 60 days prior to the study procedure.
- Villalta score ≥8 for the affected limb within 30 days prior to the study procedure.
- 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
- Treated with mechanical thrombectomy within 2 weeks of the study thrombolysis procedure.
- Treated with thrombolysis drugs within 48 hours of the study thrombolytic procedure.
- Life expectancy less 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.
- No flow in popliteal vein on duplex imaging
- Isolated iliac vein only thrombus.
- 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.
- Active bleeding, recent ( 700,000 cells/mm^3 within 24 hours prior to the procedure.
- Creatinine outside the normal range for the treating institution and considered clinically significant by the Investigator.
- Uncontrolled hypertension, defined as systolic >175 millimeters of mercury (mmHg) and a diastolic >110 mmHg.
- Use of clopidogrel, ticlopidine, or other thienopyridine antiplatelet drug within 7 days of the study procedure.
- In the judgment of the clinician, the participant is at high risk for catastrophic bleeding.
Data sourced from ClinicalTrials.gov (NCT02159521). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.