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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Other cardiovascular diseases
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Lutonix DCB - Lutonix Paclitaxel Drug Coated Balloon

Active comparator: PTA Catheter - Standard Uncoated PTA Catheter
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.
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.
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
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.
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.
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
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.
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.
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.
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
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
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
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
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
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.
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.
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
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.
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.
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
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
Sex
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
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/06/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/06/2021
Sample size
Target
Accrual to date
Final
442
Recruitment in Australia
Recruitment state(s)
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
Other
Name [1] 0 0
Dr. Reddy's Laboratory
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Bard Ltd
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Citius Pharmaceuticals
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01870401