Lutonix DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01870401 |
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Recruitment Status :
Completed
First Posted : June 6, 2013
Results First Posted : August 12, 2020
Last Update Posted : February 9, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Critical Limb Ischemia | Device: Lutonix DCB Device: Uncoated PTA Catheter | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 442 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Treatment |
| Official 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) |
| Actual Study Start Date : | June 3, 2013 |
| Actual Primary Completion Date : | May 17, 2018 |
| Actual Study Completion Date : | June 22, 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Lutonix DCB
Lutonix Paclitaxel Drug Coated Balloon
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Device: Lutonix DCB
Other Name: LTX DCB |
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Active Comparator: PTA Catheter
Standard Uncoated PTA Catheter
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Device: Uncoated PTA Catheter
Other Name: PTA |
- 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. [ Time Frame: 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. [ Time Frame: 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.
- Percentage of Lesions Considered Technical Success at Time of Index Procedure [ Time Frame: 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.
- Percentage of Procedures With Procedural Success at Time of Index Procedure. [ Time Frame: 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.
- 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. [ 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. [ Time Frame: 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 [ Time Frame: 12 months post-index procedure ]
- Number of Healed Wounds at 30 Days, 6 and 12 Months Post Index Procedure [ Time Frame: 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.
- 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. [ Time Frame: 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.
- Change in Rutherford Classification Scores at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline. [ Time Frame: 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.
- 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. [ Time Frame: 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.
- Percentage of Participants With Freedom From Primary Patency Failure at 30 Days, 6 and 12 Months Post Index Procedure [ Time Frame: 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 With Primary Patency Excluding Early Mechanical Recoil at 30 Days, 6 and 12 Months Post Index Procedure [ Time Frame: 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 Lesions With Secondary Patency at 30 Days, 6 and 12 Months Post Index Procedure [ Time Frame: 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.
- 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 [ Time Frame: 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.
- Change in Ankle Brachial Index (ABI) at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline [ Time Frame: 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.
- Change in Walking Impairment Questionnaire (WIQ) Scores at 30 Days, 6 and 12 Months Post Index Procedure Compared to Baseline. [ Time Frame: 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 [ 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. [ Time Frame: 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. [ 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 [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01870401
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| Principal Investigator: | Patrick Geraghty, MD | Washington University School of Medicine | |
| Principal Investigator: | Jihad Mustapha, MD | Metro Health Hospital | |
| Principal Investigator: | Marianne Brodmann, MD | Medical University Graz, Austria |
Documents provided by C. R. Bard:
| Responsible Party: | C. R. Bard |
| ClinicalTrials.gov Identifier: | NCT01870401 |
| Other Study ID Numbers: |
CL0005-01 |
| First Posted: | June 6, 2013 Key Record Dates |
| Results First Posted: | August 12, 2020 |
| Last Update Posted: | February 9, 2022 |
| Last Verified: | February 2022 |
| Studies a U.S. FDA-regulated Device Product: | Yes |
| Device Product Not Approved or Cleared by U.S. FDA: | Yes |
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Ischemia Pathologic Processes |