Lutonix DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries

A Prospective, Multicenter, Single Blind, Randomized, Controlled Trial Comparing the Lutonix Drug Coated Balloon Versus Standard Balloon Angioplasty for Treatment of Below-the-Knee (BTK) Arteries(Lutonix BTK Trial)

To assess the safety and efficacy of the Lutonix Drug Coated Balloon (DCB) for treatment of stenosis or occlusion of native below-the-knee arteries.

Study Overview

• Status: Completed
• Conditions: Critical Limb Ischemia
• Intervention / Treatment: Device: Lutonix DCB; Device: Uncoated PTA Catheter

• Study Type: Interventional
• Enrollment (Actual): 442
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, A-8036
    • Medical University Graz
• Belgium
  • Genk, Belgium, 3600
    • ZOL St. jan
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G2M9
      • University Health Network
• Germany
  • Arnsberg, Germany, 59759
    • Klinik für Kardiologie • Klinikum Arnsberg GmbH
  • Bad Krozingen, Germany, 79189
    • Universitaets Herzzentrum Freiburg/Bad Krozingen
  • Heidelberg, Germany, 69120
    • Med. Universitaet Heidelberg,Herzzentrum (Abteilung Innere Medizin III)
  • Immenstadt, Germany, 87509
    • Hospital Kempten
  • Leipzig, Germany, 04103
    • Universitaetsklinikum Leipzig Medical Centre
  • Münster, Germany, 48149
    • Universitätsklinikum Münster, Innere Medizin C
  • Sonneberg, Germany, 96515
    • Medinos Kliniken des Landkriess Sonneberg GmbH
  • Tübingen, Germany, 72076
    • University of Tubingen, Dept. of Diagnostic and Interventional Radiology
• Italy
  • Cotignola, Italy
    • Maria Cecilia Hospital
• Japan
  • Kasukabe, Japan, 344-0063
    • Kasukabe Chuo General Hospital
  • Minato-ku, Tokyo, Japan, 105-0003
    • The Jikei University Hospital
  • Osaka, Japan, 536-0025
    • Morinomiya Hospital
  • Osaka, Japan, 596-8522
    • Kishiwada Tokushukai Hospital
  • Tokyo, Japan, 153-8515
    • Toho University
• Switzerland
  • Luzern, Switzerland, 6000
    • Kantonsspital Luzern
• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale University-Yale New Haven Hospital
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • MedStar Washington Hospital Center
  • Florida
    • Bradenton, Florida, United States, 34208
      • Cardiovascular Solutions Institute, LLC
    • Clearwater, Florida, United States, 33756
      • Morton Plant Mease Health Care, Inc
    • Gainesville, Florida, United States, 32611
      • University of Florida
    • Gainesville, Florida, United States, 32605
      • Cardiovascular Research of North Florida, LLC
    • Lakeland, Florida, United States, 33805
      • Radiology and Imaging Specialists of Lakeland, P.A
    • Miami Beach, Florida, United States, 33140
      • Mt. Sinai Medical Center
  • Illinois
    • Springfield, Illinois, United States, 62701
      • Prairie Education and Research Cooperative
  • Iowa
    • West Des Moines, Iowa, United States, 50266
      • Central Iowa Hospital Corporation
  • Louisiana
    • Houma, Louisiana, United States, 70360
      • CIS Clinical Research Corporation
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02135
      • Steward St. Elizabeth Medical Center of Boston
  • Michigan
    • Wyoming, Michigan, United States, 49519
      • Metro Health-University of Michigan Health Hospital
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • Jackson Heart Clinic, P.A.
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Barnes Jewish Hospital
  • New Jersey
    • Browns Mills, New Jersey, United States, 08015
      • Deborah Heart & Lung Ctr
    • Teaneck, New Jersey, United States, 07666
      • Holy Name Medical Center
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • New Mexico Heart Institute, LLC
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai School of Medicine
  • North Carolina
    • Raleigh, North Carolina, United States, 27607
      • NC Heart & Vascular Research
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • Trihealth Heart Institute
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
    • Columbus, Ohio, United States, 43214-3907
      • OhioHealth Corporation
  • Oregon
    • Portland, Oregon, United States, 97225
      • Providence Health & Service - Oregon
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • The Miriam Hospital - A Lifespan Partner
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • University Surgical Associates, LLC
    • Kingsport, Tennessee, United States, 37660
      • Wellmont Cardiology Services, Inc.
  • Texas
    • Austin, Texas, United States, 78756
      • Austin Heart PLLC
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Medical Group
  • West Virginia
    • Charleston, West Virginia, United States, 25304
      • Charleston Area Medical Center Health System
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora St. Luke's Vascular Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or non-pregnant female ≥18 years of age;
• Rutherford Clinical Category 3, 4 & 5;
• Life expectancy ≥ 1 year;
• Significant stenosis (≥70%)
• A patent inflow artery;
• Target vessel(s) diameter between 2 and 4 mm;
• Target vessel(s) reconstitute(s) at or above the ankle

Exclusion Criteria:

• Pregnant or planning on becoming pregnant;
• History of stroke within 3 months;
• History of MI, thrombolysis or angina within 30 days of enrollment;
• Planned major amputation (of either leg)
• Prior major amputation if amputation occurred less than one year prior to enrollment and if patient is not independently ambulating;
• GFR ≤ 30 ml/min per 1.73m2;
• Acute limb ischemia;
• In-stent restenosis of target lesion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lutonix DCB; Lutonix Paclitaxel Drug Coated Balloon	Device: Lutonix DCB; Other Names: LTX DCB
Active Comparator: PTA Catheter; Standard Uncoated PTA Catheter	Device: Uncoated PTA Catheter; Other Names: PTA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Freedom From Below-the-Knee (BTK) Major Adverse Limb Event and Peri-Operative Death (POD) at 30 Days Post Index Procedure.	The primary safety endpoint is defined as freedom from the composite of all-cause death, above-ankle amputation or major reintervention (new bypass graft, jump/interposition graft revision, or thrombectomy/thrombolysis) of the index limb involving a below-the-knee artery.	30 days post index procedure
Number of Participants With Freedom From the Composite of Above-ankle Amputation, Target Lesion Occlusion, and Clinically-driven Target Lesion Revascularization at 6 Months Post Index Procedure.	The primary efficacy endpoint is defined as freedom from the composite of above-ankle amputation, target lesion occlusion, and clinically-driven target lesion revascularization. All amputations included in endpoints refer to amputations in the index limb.	6 months post-index procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Lesions Considered Technical Success at Time of Index Procedure	Technical Success: A success is determined if the device success was achieved and a final residual stenosis post study device (DCB or placebo) dilatation ≤ 30% was reported.	At time of index procedure
Percentage of Procedures With Procedural Success at Time of Index Procedure.	A success is determined if there is restoration of at least 1 infrapopliteal artery with residual stenosis ≤ 30% (or ≤ 50% depending upon the version of the protocol) and inline outflow to the foot, irrespective of device success, and without a major adverse event during the index procedure.	At time of Index Procedure
Comparison of the Below the Knee (BTK) Major Adverse Limb Event (MALE) and Perioperative Death (POD) Rate to a Performance Goal at 30 Days Post Index Procedure.		30 days post index procedure
Change in European Quality of Life 5 Dimensions (EuroQol -5D) Scores at 30 Days, 6 and 12 Months Compared to Baseline.	Mean change in EuroQol (EQ-5D) scores at 30 days, 6, and 12 months compared to baseline. The EurolQol-5D system rates quality of life using five dimensions including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels of ratings, that is, no problems, slight problems, moderate problems, severe problems and extreme problems that can be selected. A visual scale allows participants to report their own perception of their health status. The overall scores range from 0 (worst) to 100 (best). Please note that the data in the table below represent the mean changes in overall scores for each group compared to their baseline data. Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.	30 days, 6 and 12 months post index procedure compared to baseline
Late Lumen Loss at 12 Months Post Index Procedure		12 months post-index procedure
Number of Healed Wounds at 30 Days, 6 and 12 Months Post Index Procedure	Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available. The number of wounds analyzed at 6 and 12 months post-index procedure includes wounds that may have appeared (new wounds) since the previous time period reporting.	30 days, 6 and 12 months post index procedure
Number of Non-Healed Wounds by Category (Improving, Stagnant and Worsening) at 30 Days, 6 and 12 Months Post-Index Procedure.		30 days, 6 and 12 months post index procedure
Percentage of Existing, New, and Recurrent Wounds at 30 Days, 6 and 12 Months Post Index Procedure.	Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.	30 days, 6 and 12 months post index procedure
Change in Rutherford Classification Scores at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline.	The endpoint summarizes the change in index-limb Rutherford Classification of participants from baseline through 36 months. Data is presented as shift from baseline Rutherford Classification data using the following categories: 1) Improvement, 2) Same, and 3) Worsened. Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.	30 days, 6 and 12 months post index procedure compared to baseline
Number of Participants With Freedom From Above Ankle Amputation, Unhealed Wound, Ischemic Rest Pain, Target Vessel Occlusion, and Clinically-Driven Target Vessel Revascularization (TVR) at 30 Days, 6 and 12 Months Post Index Procedure.	The composite endpoint of freedom from above ankle amputation (CEC-adjudicated), unhealed wound (presence of wound vs. no wound), ischemic rest pain (Rutherford category 4 or higher), target vessel occlusion (based on DUS and/or angiograph), and clinically-driven TVR (CEC-adjudicated). Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.	30 days, 6 and 12 months post index procedure
Percentage of Participants With Freedom From Primary Patency Failure at 30 Days, 6 and 12 Months Post Index Procedure	Primary patency is defined as the absence of both total occlusion (100% diameter stenosis) in all of the target lesions in a flow pathway as well as a clinically-driven Target Lesion Revascularization (TLR). Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.	30 days and at 6 and 12 months
Percentage of Lesions With Primary Patency Excluding Early Mechanical Recoil at 30 Days, 6 and 12 Months Post Index Procedure	Primary patency with exclusion of early mechanical recoil of the target flow pathway is defined as the absence of both total occlusion (100% diameter stenosis) of the target lesions and clinically-driven TLR events > 30 days. Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.	30 days, 6 and 12 months post index procedure
Number of Lesions With Secondary Patency at 30 Days, 6 and 12 Months Post Index Procedure	The secondary patency of the target lesion is defined as the absence of total occlusion (100% diameter stenosis) of the target lesions based on angiography (if performed) or ultrasound as analyzed by the angiographic Core Lab. Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.	30 days, 6 and 12 months post index procedure
Composite of Freedom From Clinically -Driven Target Lesion Revascularization (TLR) and From 50% DS by Angiography or Duplex Ultrasound at 30 Days, 6 and 12 Months Post Index Procedure.		30 days, 6 and 12 months post index procedure
Change in Toe Brachial Index (TBI) at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline	Mean change from baseline values. The Toe Brachial Index (TBI) is defined as a ratio of toe to brachial (upper arm) artery systolic blood pressure and aims at determining how well the blood is flowing in the legs. Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.	30 days, 6 and 12 months post index procedure compared to baseline
Change in Ankle Brachial Index (ABI) at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline	Mean change from baseline values. The Ankle Brachial Index (ABI) is defined as a ratio of ankle to brachial (upper arm) artery systolic blood pressure and aims at determining how well the blood is flowing in the legs. Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.	30 days, and at 6 and 12 months compared to baseline
Change in Walking Impairment Questionnaire (WIQ) Scores at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline.	The WIQ assesses 3 categories of activities that include 1) walking distance, 2) stair-climbing, and 3) walking speed. Each question requires participants to rate their degree of difficulty with the activity on a scale of 0 (unable) to 4 (no problem). Final scores range from 0% to 100%, with lower percentages indicating higher levels of difficulties with activities.The results below represent the mean differences in total Walking Impairment Questionnaire (WIQ) scores at 30 days 6 and 12 months, compared to baseline assessment scores. Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.	30 days, 6 and 12 months post index procedure compared to baseline
Number of Participants With Clinically-Driven Target Lesion Revascularization (TLR) at 30 Days, 6 and 12 Months Post Index Procedure		30 days, 6 and 12 months post index procedure
Cumulative Number of Target Lesion Revascularization (TLR) at 30 Days, 6 and 12 Months Post Index Procedure.	Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.	30 days, 6 and 12 months post index procedure
Number of Participants With Clinically-Driven Target Vessel Revascularization (TVR) at 30 Days, 6 and 12 Months Post Index Procedure.		30 days, 6 and 12 months post index procedure
Cumulative Number of Target Vessel Revascularization (TVR) at 30 Days, 6 and 12 Months Post Index Procedure.		30 days, 6 and 12 months post index procedure
Percentage of Participants With Freedom From Limb Amputation at 30 Days, 6 and 12 Months Post Index Procedure	Limb salvage defined as no amputation of target limb.	30 days and at 6 and 12 months
Percentage of Participants With Freedom From Unplanned Below the Knee (BTK) Amputation of the Target Limb at 30 Days, 6 and 12 Months Post Index Procedure.	Defined as amputation that was below the ankle, including digit amputation. Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.	30 days, 6 and 12 months post index procedure
Cumulative Number of of Below the Knee (BTK) Index-Limb Reinterventions at 30 Days, 6 and 12 Months Post Index Procedure.	The overall burden of BTK reinterventions was defined as the total number of BTK index-limb re-interventions and major amputations for each time point. Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.	30 days, 6 and 12 months post index procedure
Percentage of Participants With Freedom From Composite of Perioperative Death (POD), Index Limb-related Death, Below the Knee Reinterventions or Major Amputations of the Index Limb at 30 Days, 6 and 12 Months Post Index Procedure	Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.	30 days, 6 and 12 months post index procedure

Collaborators and Investigators

• Sponsor: C. R. Bard
• Collaborators: Bard Ltd
• Investigators: Principal Investigator: Patrick Geraghty, MD, Washington University School of Medicine; Principal Investigator: Marianne Brodmann, MD, Medical University Graz, Austria

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2013
• Primary Completion (Actual): May 17, 2018
• Study Completion (Actual): June 22, 2021

Study Registration Dates

• First Submitted: May 7, 2013
• First Submitted That Met QC Criteria: June 3, 2013
• First Posted (Estimate): June 6, 2013

Study Record Updates

• Last Update Posted (Actual): February 9, 2022
• Last Update Submitted That Met QC Criteria: February 3, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Ischemia
• Other Study ID Numbers: CL0005-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes