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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
442
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.
Time frame: 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.
Time frame: 6 months post-index procedure
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.
Time frame: 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.
Time frame: 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.
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Yale University-Yale New Haven Hospital
New Haven, Connecticut, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Cardiovascular Solutions Institute, LLC
Bradenton, Florida, United States
Morton Plant Mease Health Care, Inc
Clearwater, Florida, United States
Cardiovascular Research of North Florida, LLC
Gainesville, Florida, United States
University of Florida
Gainesville, Florida, United States
Radiology and Imaging Specialists of Lakeland, P.A
Lakeland, Florida, United States
Mt. Sinai Medical Center
Miami Beach, Florida, United States
Prairie Education and Research Cooperative
Springfield, Illinois, United States
Central Iowa Hospital Corporation
West Des Moines, Iowa, United States
...and 41 more locations
Time frame: 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.
Time frame: 30 days, 6 and 12 months post index procedure compared to baseline
Late Lumen Loss at 12 Months Post Index Procedure
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 30 days, 6 and 12 months post index procedure