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

NCT02159521 | Completed Phase 4 Results

• 1 other identifier: EKOS-11
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 22

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.

Conditions

Deep Vein Thrombosis; Post-thrombotic Syndrome

Keywords

deep vein thrombosis; post-thrombotic syndrome; chronic deep vein thrombosis

Outcome Measures

Primary Outcomes (4)

• Change From Baseline in Villalta Score at Day 30 Post-EkoSonic® Study Treatment Procedure

  Clinical efficacy was evaluated using the Villalta score at Baseline compared to 30 days Post-EkoSonic® study treatment procedure. Villalta scale (post thrombotic syndrome score) is used for the assessment of symptoms and clinical signs. Participants rated the following symptoms for each leg: pain, cramps, heaviness, pruritus, and paresthesia on a scale ranging from 0 (not present/minimal) to 3 (severe). The study coordinator or nurse rated the following clinical signs in participants for each leg: pre-tibial edema, induration of the skin, hyperpigmentation, new venous extasia, redness during calf compression, and pain during calf compression on a scale ranging from 0 (not present/minimal) to 3 (severe). Total score ranged from 0 to 33. Higher scores represent more severe disease.

  Baseline (within 30 days of treatment), Day 30

• Percentage of Segments of Limbs That Achieved at Least 4-Point Reduction From Baseline in Villalta Score at Day 30

  Clinical efficacy was evaluated using the Villalta score at Baseline compared to 30 days Post-EkoSonic® study treatment procedure. Limbs with revascularization procedures were considered non-responders. Villalta scale (post thrombotic syndrome score) is used for the assessment of symptoms and clinical signs. Participants rated the following symptoms for each leg: pain, cramps, heaviness, pruritus, and paresthesia on a scale ranging from 0 (not present/minimal) to 3 (severe). The study coordinator or nurse rated the following clinical signs in participants for each leg: pre-tibial edema, induration of the skin, hyperpigmentation, new venous extasia, redness during calf compression, and pain during calf compression on a scale ranging from 0 (not present/minimal) to 3 (severe). Total score ranged from 0 to 33. Higher scores represent more severe disease.

  Baseline (within 30 days of treatment), Day 30

• Change From Baseline in Blood Flow (Calculated by Time to Washout in the Affected Segment) at Post-Adjunctive Therapy

  Change in blood flow was calculated by time to washout in the affected segments in the participants. Time to femoral vein (FV) washout and external iliac vein (EIV) washout was reported.

  Baseline (Within 30 days of treatment), Day 0

• Number of Participants With Major Bleeding

  Major bleeding was defined as: Fatal bleeding; and/or symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome; and/or bleeding causing a fall in hemoglobin of ≥2.0 grams/deciliter (g/dL), or leading to transfusion of ≥2 units of whole blood or red blood cells. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

  From start of study drug infusion up to 72 hours

Secondary Outcomes (14)

• Change From Baseline in Ouriel Score (Venous Volumetric Index [VVI]) at Post-Adjunctive Therapy

  Baseline (Within 30 days of treatment), Day 0

• Number of Participants With at Least 5-Point Reduction From Baseline in Ouriel Score at Post-Adjunctive Therapy

  Baseline (Within 30 days of treatment), Day 0

• Change From Baseline in Villalta Score at Days 90, 180, and 365 Post-EkoSonic® Study Treatment Procedure

  Baseline (within 30 days of treatment), Days 90, 180, and 365

• Percentage of Segments of Limbs That Achieved at Least 4-Point Reduction From Baseline in Villalta Score at Days 90, 180, and 365

  Baseline (within 30 days of treatment), Days 90, 180, and 365

• Percentage of Treated Veins Segments of Limbs With Absence of Re-Occlusion, as Documented by Duplex Imaging

  Day 365

Study Arms (1)

EkoSonic® Endovascular System

EXPERIMENTAL

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.

Device: EkoSonic® Endovascular System; Biological: Alteplase

Interventions

EkoSonic® Endovascular System DEVICE

EkoSonic® Endovascular System

Alteplase BIOLOGICAL

Recombinant tissue plasminogen activator

EkoSonic® Endovascular System

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 (\<) 1 year.
• 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.
• 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 (\<3 months) gastrointestinal (GI) bleeding, active peptic ulcer, severe liver dysfunction, and bleeding diathesis.
• 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.
• History of stroke or intracranial/intraspinal bleed, tumor, vascular malformation, or aneurysm.
• 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.
• Hemoglobin \<9.0 milligrams/deciliter (mg/dL) within 24 hours prior to the procedure
• International normalized ratio (INR) ≥1.5 nanograms/deciliter (ng/dL) within 24 hours prior to the procedure.
• Platelet count \<100,000 cells/cubic millimeter (cells/mm\^3) or \>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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead
• EKOS Corporation: collaborator

Study Sites (22)

UCLA Medical Center

Los Angeles, California, 90024, United States

Location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Vascular Breakthroughs

Darien, Connecticut, 06820, United States

Location

Christiana Hospital

Newark, Delaware, 19718, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Piedmont Atlanta Hospital

Atlanta, Georgia, 30309, United States

Location

Medical Center of Central Georgia

Macon, Georgia, 31201, United States

Location

University of Louisville Research Foundation

Louisville, Kentucky, 40202, United States

Location

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

Maine Medical Center

Portland, Maine, 04106, United States

Location

University of Michigan Medical Center

Ann Arbor, Michigan, 48109, United States

Location

CHI Health St. Elizabeth

Lincoln, Nebraska, 68510, United States

Location

Holy Name Medical Center

Teaneck, New Jersey, 07666, United States

Location

NYU Langone Medical Center

New York, New York, 10016, United States

Location

Weill Cornell Medical Center

New York, New York, 10024, United States

Location

Aultman Hospital

Canton, Ohio, 44708, United States

Location

Fairfield Medical Center

Lancaster, Ohio, 43130, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

DFW Vascular Group/ Methodist Dallas Medical Ctr

Dallas, Texas, 75208, United States

Location

Houston Methodist Sugar Land Hospital

Sugar Land, Texas, 77479, United States

Location

Inova Alexandria Hospital

Alexandria, Virginia, 22304, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

Related Publications (1)

• 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.

  PMID: 31983322 DERIVED

Related Links

• study website
• EKOS company website

MeSH Terms

Conditions

Venous Thrombosis; Postthrombotic Syndrome

Interventions

Tissue Plasminogen Activator

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Venous Insufficiency

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors

Results Point of Contact

• Title: David Hahn
• Organization: EKOS Corporation

David.Hahn@btgplc.com

4254153100

Study Officials

• Mark Garcia, MD

  Wilmington DE

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2014
• First Posted: June 10, 2014
• Study Start: July 10, 2014
• Primary Completion: November 30, 2017
• Study Completion: November 30, 2017
• Last Updated: July 19, 2021
• Results First Posted: February 18, 2020

Record last verified: 2021-07

Locations

US (22)