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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01870401
Registration number
NCT01870401
Ethics application status
Date submitted
7/05/2013
Date registered
6/06/2013
Date last updated
9/02/2022
Titles & IDs
Public title
Lutonix DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries
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Scientific title
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)
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Secondary ID [1]
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CL0005-01
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Critical Limb Ischemia
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Condition category
Condition code
Cardiovascular
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Other cardiovascular diseases
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Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Lutonix DCB
Treatment: Devices - Uncoated PTA Catheter
Experimental: Lutonix DCB - Lutonix Paclitaxel Drug Coated Balloon
Active Comparator: PTA Catheter - Standard Uncoated PTA Catheter
Treatment: Devices: Lutonix DCB
Treatment: Devices: Uncoated PTA Catheter
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
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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.
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Timepoint [1]
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30 days post index procedure
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Primary outcome [2]
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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.
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Assessment method [2]
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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.
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Timepoint [2]
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6 months post-index procedure
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Secondary outcome [1]
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Percentage of Lesions Considered Technical Success at Time of Index Procedure
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Assessment method [1]
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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.
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Timepoint [1]
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At time of index procedure
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Secondary outcome [2]
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Percentage of Procedures With Procedural Success at Time of Index Procedure.
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Assessment method [2]
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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.
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Timepoint [2]
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At time of Index Procedure
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Secondary outcome [3]
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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.
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Assessment method [3]
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Timepoint [3]
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30 days post index procedure
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Secondary outcome [4]
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Change in European Quality of Life 5 Dimensions (EuroQol -5D) Scores at 30 Days, 6 and 12 Months Compared to Baseline.
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Assessment method [4]
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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.
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Timepoint [4]
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30 days, 6 and 12 months post index procedure compared to baseline
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Secondary outcome [5]
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Late Lumen Loss at 12 Months Post Index Procedure
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Assessment method [5]
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Timepoint [5]
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12 months post-index procedure
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Secondary outcome [6]
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Number of Healed Wounds at 30 Days, 6 and 12 Months Post Index Procedure
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Assessment method [6]
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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.
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Timepoint [6]
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30 days, 6 and 12 months post index procedure
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Secondary outcome [7]
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Number of Non-Healed Wounds by Category (Improving, Stagnant and Worsening) at 30 Days, 6 and 12 Months Post-Index Procedure.
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Assessment method [7]
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Timepoint [7]
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30 days, 6 and 12 months post index procedure
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Secondary outcome [8]
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Percentage of Existing, New, and Recurrent Wounds at 30 Days, 6 and 12 Months Post Index Procedure.
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Assessment method [8]
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Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.
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Timepoint [8]
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30 days, 6 and 12 months post index procedure
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Secondary outcome [9]
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Change in Rutherford Classification Scores at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline.
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Assessment method [9]
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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.
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Timepoint [9]
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30 days, 6 and 12 months post index procedure compared to baseline
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Secondary outcome [10]
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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.
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Assessment method [10]
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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.
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Timepoint [10]
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30 days, 6 and 12 months post index procedure
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Secondary outcome [11]
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Percentage of Participants With Freedom From Primary Patency Failure at 30 Days, 6 and 12 Months Post Index Procedure
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Assessment method [11]
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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.
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Timepoint [11]
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30 days and at 6 and 12 months
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Secondary outcome [12]
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Percentage of Lesions With Primary Patency Excluding Early Mechanical Recoil at 30 Days, 6 and 12 Months Post Index Procedure
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Assessment method [12]
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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.
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Timepoint [12]
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30 days, 6 and 12 months post index procedure
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Secondary outcome [13]
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Number of Lesions With Secondary Patency at 30 Days, 6 and 12 Months Post Index Procedure
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Assessment method [13]
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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.
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Timepoint [13]
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30 days, 6 and 12 months post index procedure
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Secondary outcome [14]
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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.
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Assessment method [14]
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Timepoint [14]
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30 days, 6 and 12 months post index procedure
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Secondary outcome [15]
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Change in Toe Brachial Index (TBI) at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline
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Assessment method [15]
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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.
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Timepoint [15]
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30 days, 6 and 12 months post index procedure compared to baseline
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Secondary outcome [16]
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Change in Ankle Brachial Index (ABI) at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline
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Assessment method [16]
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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.
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Timepoint [16]
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30 days, and at 6 and 12 months compared to baseline
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Secondary outcome [17]
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Change in Walking Impairment Questionnaire (WIQ) Scores at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline.
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Assessment method [17]
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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.
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Timepoint [17]
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30 days, 6 and 12 months post index procedure compared to baseline
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Secondary outcome [18]
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Number of Participants With Clinically-Driven Target Lesion Revascularization (TLR) at 30 Days, 6 and 12 Months Post Index Procedure
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Assessment method [18]
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Timepoint [18]
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30 days, 6 and 12 months post index procedure
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Secondary outcome [19]
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Cumulative Number of Target Lesion Revascularization (TLR) at 30 Days, 6 and 12 Months Post Index Procedure.
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Assessment method [19]
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Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.
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Timepoint [19]
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30 days, 6 and 12 months post index procedure
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Secondary outcome [20]
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Number of Participants With Clinically-Driven Target Vessel Revascularization (TVR) at 30 Days, 6 and 12 Months Post Index Procedure.
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Assessment method [20]
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Timepoint [20]
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30 days, 6 and 12 months post index procedure
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Secondary outcome [21]
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Cumulative Number of Target Vessel Revascularization (TVR) at 30 Days, 6 and 12 Months Post Index Procedure.
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Assessment method [21]
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Timepoint [21]
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30 days, 6 and 12 months post index procedure
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Secondary outcome [22]
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Percentage of Participants With Freedom From Limb Amputation at 30 Days, 6 and 12 Months Post Index Procedure
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Assessment method [22]
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Limb salvage defined as no amputation of target limb.
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Timepoint [22]
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30 days and at 6 and 12 months
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Secondary outcome [23]
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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.
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Assessment method [23]
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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.
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Timepoint [23]
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30 days, 6 and 12 months post index procedure
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Secondary outcome [24]
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Cumulative Number of of Below the Knee (BTK) Index-Limb Reinterventions at 30 Days, 6 and 12 Months Post Index Procedure.
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Assessment method [24]
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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.
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Timepoint [24]
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30 days, 6 and 12 months post index procedure
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Secondary outcome [25]
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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
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Assessment method [25]
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Results for 24 and 36 months will be reported when the final Clinical Study Report becomes available.
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Timepoint [25]
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30 days, 6 and 12 months post index procedure
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
3/06/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
22/06/2021
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Sample size
Target
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Accrual to date
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Final
442
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Connecticut
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United States of America
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District of Columbia
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United States of America
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Florida
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United States of America
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Illinois
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United States of America
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Iowa
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United States of America
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Louisiana
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United States of America
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Massachusetts
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United States of America
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Michigan
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0
United States of America
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Mississippi
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0
United States of America
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Missouri
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0
United States of America
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New Jersey
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0
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United States of America
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New Mexico
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United States of America
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New York
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0
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Oregon
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United States of America
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Rhode Island
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0
United States of America
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South Carolina
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0
0
United States of America
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Tennessee
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0
United States of America
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Texas
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0
United States of America
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Virginia
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United States of America
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West Virginia
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United States of America
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Wisconsin
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Austria
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Graz
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Belgium
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Genk
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Canada
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Ontario
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Germany
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Arnsberg
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Germany
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Bad Krozingen
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Germany
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Heidelberg
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Germany
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Immenstadt
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Germany
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Leipzig
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Germany
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Münster
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Germany
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Sonneberg
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Germany
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Tübingen
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Italy
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Cotignola
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Japan
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Kasukabe
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Japan
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Minato-ku, Tokyo
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Japan
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Osaka
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Japan
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Tokyo
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Switzerland
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Luzern
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
C. R. Bard
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Bard Ltd
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Address [1]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01870401
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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Patrick Geraghty, MD
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Address
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Washington University School of Medicine
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01870401
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