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Trial registered on ANZCTR


Registration number
ACTRN12613000336785
Ethics application status
Approved
Date submitted
24/03/2013
Date registered
27/03/2013
Date last updated
8/07/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Drug-coated angioplasty balloons for subjects with constriction or blockage in the leg arteries, specifically the Superficial Femoral or Popliteal Arteries: A pharmacokinetic study.
Scientific title
ProspectIve, SingLe-Arm, MuLti-Center, Pharmacokinetic Study to EvalUate TreatMent of Obstructive SupErficial Femoral Artery or Popliteal LesioNs With A Novel PacliTaxel-CoatEd Percutaneous Angioplasty Balloon
Secondary ID [1] 282159 0
Nil known
Universal Trial Number (UTN)
U1111-1140-8713
Trial acronym
Spectranetics ILLUMENATE PK
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Occluded Superficial Femoral or Popliteal Arteries 288664 0
Stenotic Superficial Femoral or Popliteal Arteries 288665 0
Re-occluded Superficial Femoral or Popliteal Arteries 288666 0
Restenotic Superficial Femoral or Popliteal Arteries 288667 0
Condition category
Condition code
Cardiovascular 289012 289012 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single use of a Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter with a dose density of 2.0 micrograms/mm^2 used in the Superficial Femoral or Popliteal Arteries.

A needle will be used to gain access to the blood vessel, then a narrow tube with the balloon inside of it will be moved to the area in the artery where the doctor needs the balloon to be positioned. The doctor will then inflate the balloon and deflate the balloon as necessary. The balloon will then be removed along with any tubes used to access the blood vessel. The procedure should take between 30 and 60 minutes to complete.
Intervention code [1] 286768 0
Treatment: Devices
Intervention code [2] 286793 0
Treatment: Surgery
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289126 0
Freedom from device and procedure related target limb major amputation or death and clinically-driven target lesion revascularization.
Timepoint [1] 289126 0
30 days (death) and 12 months (amputation and target lesion revascularization) post-procedure.
Primary outcome [2] 289127 0
Determination of circulating blood paclitaxel concentration.
Timepoint [2] 289127 0
Immediately after last balloon deployment, 1, 4, 24 hours, 7, 14, 30, 60 days and 6 months (as applicable) post-procedure.
Secondary outcome [1] 301879 0
Measurements of Pharmacokinetics variables: Cmax, Tmax, area under the curve (AUC) (0-t) and half-life.
Timepoint [1] 301879 0
Immediately after last balloon deployment, 1, 4, 24 hours, 7, 14, 30, 60 days and 6 months (as applicable) post-procedure.
Secondary outcome [2] 301880 0
Patency. Defined as the absence of target lesion restenosis determined by Duplex Ultrasound Peak Systolic Velocity Ratio (PSVR) less than or equal to 2.5 or angiographic assessment (stenosis >50%) and freedom from target lesion revascularization.
Timepoint [2] 301880 0
6, 12 and 24 months post-procedure.
Secondary outcome [3] 301881 0
Major adverse event (MAE) rate defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR).
Timepoint [3] 301881 0
In hospital and at 1, 6, 12 and 24 months post-procedure.
Secondary outcome [4] 301882 0
Rate of vascular access and bleeding complications.
Timepoint [4] 301882 0
In hospital and at 1, 6, 12 and 24 months post-procedure.
Secondary outcome [5] 301883 0
Rate of clinically-driven target lesion revascularization. Determined as any percutaneous intervention or surgical bypass of the target lesion.
Timepoint [5] 301883 0
6, 12 and 24 months post-procedure.
Secondary outcome [6] 301884 0
Rate of clinically-driven target vessel revascularization. Determined as any percutaneous intervention or surgical bypass of the target vessel.
Timepoint [6] 301884 0
6, 12 and 24 months post-procedure.
Secondary outcome [7] 301885 0
Rate of target limb major amputation.
Timepoint [7] 301885 0
6, 12 and 24 months post-procedure.
Secondary outcome [8] 301886 0
Mortality rate.
Timepoint [8] 301886 0
6, 12 and 24 months post-procedure.
Secondary outcome [9] 301887 0
Lesion success. Defined as achievement of a final in-lesion residual diameter stenosis of less than or equal to 50% (by Quantitative Angiography), using any device after wire passage through the lesion.
Timepoint [9] 301887 0
After wire passage through the lesion.
Secondary outcome [10] 301888 0
Technical Success. Defined as achievement of a final in-lesion residual diameter stenosis of less than or equal to 50% (by Quantitative Angiography), using the CVI Paclitaxel-coated PTA Catheter without a device malfunction after wire passage through the lesion.
Timepoint [10] 301888 0
After wire passage through the lesion.
Secondary outcome [11] 301889 0
Ankle-Brachial Index (ABI) changes.
Timepoint [11] 301889 0
6, 12 and 24 months post-procedure.
Secondary outcome [12] 301890 0
Change in walking impairment questionnaire.
Timepoint [12] 301890 0
6, 12 and 24 months post-procedure.
Secondary outcome [13] 301891 0
Change in walking distance. Determined by a 6 minute walk test.
Timepoint [13] 301891 0
6, 12 and 24 months post-procedure.
Secondary outcome [14] 301892 0
Change in Rutherford classification grades.
Timepoint [14] 301892 0
6, 12 and 24 months post-procedure for the treated limb.
Secondary outcome [15] 301921 0
Arterial thrombosis.
Timepoint [15] 301921 0
6, 12 and 24 months post-procedure.

Eligibility
Key inclusion criteria
Subjects can be enrolled if they have symptomatic leg ischemia, requiring treatment of the Superficial Femoral Artery (SFA) or popliteal artery; Rutherford classification of 2, 3 or 4; de novo or restenotic lesion(s) >70% within the SFA and/or popliteal artery that are greater than or equal to 3 cm and less than or equal to 20 cm in cumulative total length with a reference vessel diameter of greater than or equal to 4 mm and less than or equal to 6 mm and with at least one patent outflow vessel.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if they have a known intolerance to study medications, paclitaxel or contrast agents, a drug coated or drug eluting stent or balloon implanted/used within 12 months of the interventional procedure, require the use of adjunctive therapies or have prohibitive calcification that precludes adequate treatment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
None
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
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 outside Australia
Country [1] 4949 0
New Zealand
State/province [1] 4949 0

Funding & Sponsors
Funding source category [1] 286927 0
Commercial sector/Industry
Name [1] 286927 0
Spectranetics
Address [1] 286927 0
9965 Federal Drive, Colorado Springs, CO 80921
Country [1] 286927 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Spectranetics
Address
9965 Federal Drive, Colorado Springs, CO 80921
Country
United States of America
Secondary sponsor category [1] 285715 0
None
Name [1] 285715 0
Address [1] 285715 0
Country [1] 285715 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288984 0
Health and Disability Ethics Committee
Ethics committee address [1] 288984 0
Ethics committee country [1] 288984 0
New Zealand
Date submitted for ethics approval [1] 288984 0
09/04/2013
Approval date [1] 288984 0
21/05/2013
Ethics approval number [1] 288984 0
13/NTA/59

Summary
Brief summary
The study was designed to describe the pharmacokinetics of paclitaxel in the blood delivered from a paclitaxel coated percutaneous angioplasty balloon catheter as a result of treatment of de novo or restenotic lesion(s), occluded/stenotic or re-occluded/restenotic lesion(s).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38638 0
Dr Andrew Holden
Address 38638 0
Interventional Radiology
Auckland City Hospital
2 Park Road
Grafton, Auckland 1023, New Zealand
Country 38638 0
New Zealand
Phone 38638 0
+ 64 9 307 4949
Fax 38638 0
Email 38638 0
AndrewH@adhb.govt.nz
Contact person for public queries
Name 38639 0
Ms Colleen Holthe
Address 38639 0
Spectranetics
Colleen Holthe
6655 Wedgwood Road North, Suite 105
Maple Grove, MN 55311 USA
Country 38639 0
United States of America
Phone 38639 0
+1-763-955-1137
Fax 38639 0
Email 38639 0
colleen.holthe@spnc.com
Contact person for scientific queries
Name 38640 0
Ms Colleen Holthe
Address 38640 0
Spectranetics
Colleen Holthe
6655 Wedgwood Road North, Suite 105
Maple Grove, MN 55311 USA
Country 38640 0
United States of America
Phone 38640 0
+1-763-955-1137
Fax 38640 0
Email 38640 0
colleen.holthe@spnc.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary