Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Not applicable
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