Lutonix DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries
- Conditions
- Critical Limb Ischemia
- Interventions
- Device: Uncoated PTA CatheterDevice: Lutonix DCB
- Registration Number
- NCT01870401
- Lead Sponsor
- C. R. Bard
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 442
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PTA Catheter Uncoated PTA Catheter Standard Uncoated PTA Catheter Lutonix DCB Lutonix DCB Lutonix Paclitaxel Drug Coated Balloon
- Primary Outcome Measures
Name Time Method 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. 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.
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. 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.
- Secondary Outcome Measures
Name Time Method Percentage of Procedures With Procedural Success at Time of Index Procedure. 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.
Change in European Quality of Life 5 Dimensions (EuroQol -5D) Scores at 30 Days, 6 and 12 Months Compared to Baseline. 30 days, 6 and 12 months post index procedure 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.
Late Lumen Loss at 12 Months Post Index Procedure 12 months post-index procedure Percentage of Existing, New, and Recurrent Wounds at 30 Days, 6 and 12 Months Post Index Procedure. 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.
Percentage of Participants With Freedom From Primary Patency Failure at 30 Days, 6 and 12 Months Post Index Procedure 30 days and at 6 and 12 months 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.Percentage of Lesions Considered Technical Success at Time of Index Procedure 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.
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 Number of Healed Wounds at 30 Days, 6 and 12 Months Post Index Procedure 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.
Change in Rutherford Classification Scores at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline. 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.Percentage of Lesions With Primary Patency Excluding Early Mechanical Recoil at 30 Days, 6 and 12 Months Post Index Procedure 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.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 Number of Lesions With Secondary Patency at 30 Days, 6 and 12 Months Post Index Procedure 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.Change in Toe Brachial Index (TBI) at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline 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.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. 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.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 Walking Impairment Questionnaire (WIQ) Scores at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline. 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.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 Change in Ankle Brachial Index (ABI) at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline 30 days, and at 6 and 12 months 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.Cumulative Number of Target Lesion Revascularization (TLR) at 30 Days, 6 and 12 Months Post Index Procedure. 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.
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 30 days and at 6 and 12 months Limb salvage defined as no amputation of target limb.
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. 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.
Cumulative Number of of Below the Knee (BTK) Index-Limb Reinterventions at 30 Days, 6 and 12 Months Post Index Procedure. 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.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 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.
Trial Locations
- Locations (51)
Steward St. Elizabeth Medical Center of Boston
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
OhioHealth Corporation
🇺🇸Columbus, Ohio, United States
Kantonsspital Luzern
🇨🇭Luzern, Switzerland
Cardiovascular Solutions Institute, LLC
🇺🇸Bradenton, Florida, United States
Yale University-Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States
Kishiwada Tokushukai Hospital
🇯🇵Osaka, Japan
Metro Health-University of Michigan Health Hospital
🇺🇸Wyoming, Michigan, United States
University Health Network
🇨🇦Toronto, Ontario, Canada
Wellmont Cardiology Services, Inc.
🇺🇸Kingsport, Tennessee, United States
Toho University
🇯🇵Tokyo, Japan
University of Florida
🇺🇸Gainesville, Florida, United States
Maria Cecilia Hospital
🇮🇹Cotignola, Italy
Cardiovascular Research of North Florida, LLC
🇺🇸Gainesville, Florida, United States
Hospital Kempten
🇩🇪Immenstadt, Germany
Mt. Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
Radiology and Imaging Specialists of Lakeland, P.A
🇺🇸Lakeland, Florida, United States
Klinik für Kardiologie • Klinikum Arnsberg GmbH
🇩🇪Arnsberg, Germany
Med. Universitaet Heidelberg,Herzzentrum (Abteilung Innere Medizin III)
🇩🇪Heidelberg, Germany
Medinos Kliniken des Landkriess Sonneberg GmbH
🇩🇪Sonneberg, Germany
The Jikei University Hospital
🇯🇵Minato-ku, Tokyo, Japan
Morton Plant Mease Health Care, Inc
🇺🇸Clearwater, Florida, United States
Jackson Heart Clinic, P.A.
🇺🇸Jackson, Mississippi, United States
University Surgical Associates, LLC
🇺🇸Chattanooga, Tennessee, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Providence Health & Service - Oregon
🇺🇸Portland, Oregon, United States
Medical University Graz
🇦🇹Graz, Austria
MedStar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Trihealth Heart Institute
🇺🇸Cincinnati, Ohio, United States
Aurora St. Luke's Vascular Center
🇺🇸Milwaukee, Wisconsin, United States
CIS Clinical Research Corporation
🇺🇸Houma, Louisiana, United States
Barnes Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
Holy Name Medical Center
🇺🇸Teaneck, New Jersey, United States
Sentara Medical Group
🇺🇸Norfolk, Virginia, United States
New Mexico Heart Institute, LLC
🇺🇸Albuquerque, New Mexico, United States
Universitaets Herzzentrum Freiburg/Bad Krozingen
🇩🇪Bad Krozingen, Germany
Universitaetsklinikum Leipzig Medical Centre
🇩🇪Leipzig, Germany
Kasukabe Chuo General Hospital
🇯🇵Kasukabe, Japan
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
Charleston Area Medical Center Health System
🇺🇸Charleston, West Virginia, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Universitätsklinikum Münster, Innere Medizin C
🇩🇪Münster, Germany
Morinomiya Hospital
🇯🇵Osaka, Japan
University of Tubingen, Dept. of Diagnostic and Interventional Radiology
🇩🇪Tübingen, Germany
Prairie Education and Research Cooperative
🇺🇸Springfield, Illinois, United States
The Miriam Hospital - A Lifespan Partner
🇺🇸Providence, Rhode Island, United States
Austin Heart PLLC
🇺🇸Austin, Texas, United States
Deborah Heart & Lung Ctr
🇺🇸Browns Mills, New Jersey, United States
Central Iowa Hospital Corporation
🇺🇸West Des Moines, Iowa, United States
NC Heart & Vascular Research
🇺🇸Raleigh, North Carolina, United States
ZOL St. Jan
🇧🇪Genk, Belgium