Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03175744




Registration number
NCT03175744
Ethics application status
Date submitted
10/03/2017
Date registered
5/06/2017
Date last updated
22/06/2023

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
Not Applicable
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
The purpose is to demonstrate the safety and effectiveness of the Stellarex DCB for the
treatment of stenosis or occlusions of below-the-knee arteries.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03175744
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03175744