Register a trial

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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/NCT03175744




Registration number
NCT03175744
Ethics application status
Date submitted
10/03/2017
Date registered
5/06/2017

Titles & IDs
Public title
Stellarex DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries
Scientific title
Prospective, Randomized, Multi-Center Study to Evaluate Treatment of Subjects With Occlusive Disease With a Novel Paclitaxel-Coated Angioplasty Balloon in Below-The-Knee (BTK) Arteries
Secondary ID [1] 0 0
D032150
Universal Trial Number (UTN)
Trial acronym
ILLUMENATE-BTK
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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Stellarex DCB
Treatment: Devices - PTA Catheter

Experimental: Stellarex DCB - Spectranetics Stellarex Drug Coated Balloon

Active comparator: PTA Catheter - Standard Uncoated Balloon Angioplasty Catheter


Treatment: Devices: Stellarex DCB
Intervention with the Stellarex DCB

Treatment: Devices: PTA Catheter
Intervention with an uncoated Standard PTA
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Freedom from Major Adverse Limb Event (MALE)
Timepoint [1] 0 0
30 days
Primary outcome [2] 0 0
Freedom from Perioperative Death (POD)
Timepoint [2] 0 0
30 days
Primary outcome [3] 0 0
Patency
Timepoint [3] 0 0
6 months
Primary outcome [4] 0 0
Limb Salvage
Timepoint [4] 0 0
6 months
Secondary outcome [1] 0 0
Clinically-driven target lesion revascularization
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
Major adverse event rates
Timepoint [2] 0 0
6 months
Secondary outcome [3] 0 0
Patency rate
Timepoint [3] 0 0
6 months

Eligibility
Key inclusion criteria
* Rutherford Clinical Category 4-5
* Life expectancy > 1 year
* Significant stenosis =70%
* Patent inflow artery
* Target vessel(s) diameter between 2 and 4 mm
* Target vessel(s) reconstitute(s) at the ankle
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Pregnant or planning to become pregnant
* History of stroke within 3 months
* Planned major amputation
* eGFR <30
* Acute limb ischemia
* Prior stent placement in 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
Suspended
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/05/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2025
Actual
Sample size
Target
Accrual to date
Final
82
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Flinders Medical Center - Bedford Park
Recruitment hospital [2] 0 0
Sir Charles Gairdner Hospital - Perth
Recruitment postcode(s) [1] 0 0
- Bedford Park
Recruitment postcode(s) [2] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Louisiana
Country [4] 0 0
United States of America
State/province [4] 0 0
New Jersey
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
United States of America
State/province [8] 0 0
South Carolina
Country [9] 0 0
Austria
State/province [9] 0 0
Graz
Country [10] 0 0
Austria
State/province [10] 0 0
Vienna
Country [11] 0 0
Belgium
State/province [11] 0 0
Bonheiden
Country [12] 0 0
Belgium
State/province [12] 0 0
Genk
Country [13] 0 0
Belgium
State/province [13] 0 0
Gent
Country [14] 0 0
Germany
State/province [14] 0 0
Arnsberg
Country [15] 0 0
Germany
State/province [15] 0 0
Bad Krozingen
Country [16] 0 0
Germany
State/province [16] 0 0
Karlsbad
Country [17] 0 0
Germany
State/province [17] 0 0
Leipzig
Country [18] 0 0
Germany
State/province [18] 0 0
Tuebingen

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Spectranetics Corporation
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Philips Healthcare
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
William Gray, MD
Address 0 0
Lankenau Heart Institute
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03175744