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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01870401




Registration number
NCT01870401
Ethics application status
Date submitted
7/05/2013
Date registered
6/06/2013
Date last updated
12/08/2020

Titles & IDs
Public title
Lutonix DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries
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)
Secondary ID [1] 0 0
CL0005-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical Limb Ischemia 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
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


Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
30 days post index procedure
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
6 months post-index procedure
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
At time of index procedure
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
At time of Index Procedure
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
30 days post index procedure
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
30 days, 6 and 12 months post index procedure compared to baseline
Secondary outcome [5] 0 0
Late Lumen Loss at 12 Months Post Index Procedure
Timepoint [5] 0 0
12 months post-index procedure
Secondary outcome [6] 0 0
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.
Timepoint [6] 0 0
30 days, 6 and 12 months post index procedure
Secondary outcome [7] 0 0
Number of Non-Healed Wounds by Category (Improving, Stagnant and Worsening) at 30 Days, 6 and 12 Months Post-Index Procedure.
Timepoint [7] 0 0
30 days, 6 and 12 months post index procedure
Secondary outcome [8] 0 0
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.
Timepoint [8] 0 0
30 days, 6 and 12 months post index procedure
Secondary outcome [9] 0 0
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.
Timepoint [9] 0 0
30 days, 6 and 12 months post index procedure compared to baseline
Secondary outcome [10] 0 0
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.
Timepoint [10] 0 0
30 days, 6 and 12 months post index procedure
Secondary outcome [11] 0 0
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.
Timepoint [11] 0 0
30 days and at 6 and 12 months
Secondary outcome [12] 0 0
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.
Timepoint [12] 0 0
30 days, 6 and 12 months post index procedure
Secondary outcome [13] 0 0
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.
Timepoint [13] 0 0
30 days, 6 and 12 months post index procedure
Secondary outcome [14] 0 0
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.
Timepoint [14] 0 0
30 days, 6 and 12 months post index procedure
Secondary outcome [15] 0 0
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.
Timepoint [15] 0 0
30 days, 6 and 12 months post index procedure compared to baseline
Secondary outcome [16] 0 0
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.
Timepoint [16] 0 0
30 days, and at 6 and 12 months compared to baseline
Secondary outcome [17] 0 0
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.
Timepoint [17] 0 0
30 days, 6 and 12 months post index procedure compared to baseline
Secondary outcome [18] 0 0
Number of Participants With Clinically-Driven Target Lesion Revascularization (TLR) at 30 Days, 6 and 12 Months Post Index Procedure
Timepoint [18] 0 0
30 days, 6 and 12 months post index procedure
Secondary outcome [19] 0 0
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.
Timepoint [19] 0 0
30 days, 6 and 12 months post index procedure
Secondary outcome [20] 0 0
Number of Participants With Clinically-Driven Target Vessel Revascularization (TVR) at 30 Days, 6 and 12 Months Post Index Procedure.
Timepoint [20] 0 0
30 days, 6 and 12 months post index procedure
Secondary outcome [21] 0 0
Cumulative Number of Target Vessel Revascularization (TVR) at 30 Days, 6 and 12 Months Post Index Procedure.
Timepoint [21] 0 0
30 days, 6 and 12 months post index procedure
Secondary outcome [22] 0 0
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.
Timepoint [22] 0 0
30 days and at 6 and 12 months
Secondary outcome [23] 0 0
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.
Timepoint [23] 0 0
30 days, 6 and 12 months post index procedure
Secondary outcome [24] 0 0
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.
Timepoint [24] 0 0
30 days, 6 and 12 months post index procedure
Secondary outcome [25] 0 0
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.
Timepoint [25] 0 0
30 days, 6 and 12 months post index procedure

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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sydney Local Health District - Camperdown
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Connecticut
Country [2] 0 0
United States of America
State/province [2] 0 0
District of Columbia
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Iowa
Country [6] 0 0
United States of America
State/province [6] 0 0
Louisiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Mississippi
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
New Jersey
Country [12] 0 0
United States of America
State/province [12] 0 0
New Mexico
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Oregon
Country [17] 0 0
United States of America
State/province [17] 0 0
Rhode Island
Country [18] 0 0
United States of America
State/province [18] 0 0
South Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Tennessee
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Virginia
Country [22] 0 0
United States of America
State/province [22] 0 0
West Virginia
Country [23] 0 0
United States of America
State/province [23] 0 0
Wisconsin
Country [24] 0 0
Austria
State/province [24] 0 0
Graz
Country [25] 0 0
Belgium
State/province [25] 0 0
Genk
Country [26] 0 0
Canada
State/province [26] 0 0
Ontario
Country [27] 0 0
Germany
State/province [27] 0 0
Arnsberg
Country [28] 0 0
Germany
State/province [28] 0 0
Bad Krozingen
Country [29] 0 0
Germany
State/province [29] 0 0
Heidelberg
Country [30] 0 0
Germany
State/province [30] 0 0
Immenstadt
Country [31] 0 0
Germany
State/province [31] 0 0
Leipzig
Country [32] 0 0
Germany
State/province [32] 0 0
Münster
Country [33] 0 0
Germany
State/province [33] 0 0
Sonneberg
Country [34] 0 0
Germany
State/province [34] 0 0
Tübingen
Country [35] 0 0
Italy
State/province [35] 0 0
Cotignola
Country [36] 0 0
Japan
State/province [36] 0 0
Kasukabe
Country [37] 0 0
Japan
State/province [37] 0 0
Minato-ku, Tokyo
Country [38] 0 0
Japan
State/province [38] 0 0
Osaka
Country [39] 0 0
Japan
State/province [39] 0 0
Tokyo
Country [40] 0 0
Switzerland
State/province [40] 0 0
Luzern

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
C. R. Bard
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Bard Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT01870401
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Patrick Geraghty, MD
Address 0 0
Washington University School of Medicine
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications