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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03175744
Ethics application status
Date submitted
10/03/2017
Date registered
5/06/2017
Date last updated
18/04/2019

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 - ILLUMENATE BTK
Secondary ID [1] 0 0
D032150
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 - 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) - Composite of major amputation or major reintervention on a per patient basis
Timepoint [1] 0 0
30 days
Primary outcome [2] 0 0
Freedom from Perioperative Death (POD) - Death on a per patient basis
Timepoint [2] 0 0
30 days
Primary outcome [3] 0 0
Patency - Freedom from target lesion occlusion and clinically driven target lesion reintervention and freedom from major amputation on a per patient basis
Timepoint [3] 0 0
6 months
Primary outcome [4] 0 0
Limb Salvage - Freedom from target lesion occlusion and clinically driven target lesion reintervention and freedom from major amputation on a per patient basis
Timepoint [4] 0 0
6 months
Secondary outcome [1] 0 0
Clinically-driven target lesion revascularization - Rate of clinically-driven target lesion revascularization
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
Major adverse event rates - Composite rate of all-cause death, major amputation and clinically driven target lesion reintervention
Timepoint [2] 0 0
6 months
Secondary outcome [3] 0 0
Patency rate - Absence of target lesion occlusion and freedom from clinically-driven target lesion reintervention
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
Gender
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
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
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
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
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
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
New Jersey
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
South Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
Austria
State/province [13] 0 0
Graz
Country [14] 0 0
Austria
State/province [14] 0 0
Vienna
Country [15] 0 0
Belgium
State/province [15] 0 0
Bonheiden
Country [16] 0 0
Belgium
State/province [16] 0 0
Genk
Country [17] 0 0
Belgium
State/province [17] 0 0
Gent
Country [18] 0 0
Germany
State/province [18] 0 0
Arnsberg
Country [19] 0 0
Germany
State/province [19] 0 0
Bad Krozingen
Country [20] 0 0
Germany
State/province [20] 0 0
Karlsbad
Country [21] 0 0
Germany
State/province [21] 0 0
Leipzig
Country [22] 0 0
Germany
State/province [22] 0 0
Tuebingen

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Spectranetics Corporation
Address
Country

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/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
Janiece Rutherford
Address 0 0
Country 0 0
Phone 0 0
1-763-955-1143
Fax 0 0
Email 0 0
janiece.rutherford@spnc.com
Contact person for scientific queries

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