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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01912937




Registration number
NCT01912937
Ethics application status
Date submitted
10/07/2013
Date registered
31/07/2013
Date last updated
18/10/2017

Titles & IDs
Public title
Pharmacokinetic Study of Drug-coated Angioplasty Balloons in the Superficial Femoral or Popliteal Arteries:
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] 0 0
TP-1363
Universal Trial Number (UTN)
Trial acronym
PK
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral Artery Disease 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 - Angioplasty treatment with the CVI Drug-coated Balloon (DCB)

Experimental: DCB Arm - Angioplasty treatment with the CVI Paclitaxel-Coated, Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (CVI Paclitaxel-coated PTA Catheter)


Treatment: Devices: Angioplasty treatment with the CVI Drug-coated Balloon (DCB)
Angioplasty treatment with the CVI Paclitaxel-Coated, Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (CVI Paclitaxel-coated PTA Catheter)
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Paclitaxel Levels
Timepoint [1] 0 0
up to 6 months
Primary outcome [2] 0 0
Freedom from Events as a Safety Measure (Composite)
Timepoint [2] 0 0
up to 12 months
Secondary outcome [1] 0 0
Measurements of Pharmacokinetics variables: Cmax, Tmax, AUC
Timepoint [1] 0 0
(0-t) and half-life

Eligibility
Key inclusion criteria
* Male or non-pregnant female greater than or equal to 18 years of age.
* Subjects with symptomatic leg ischemia, requiring treatment of the Superficial Femoral Artery (SFA) or popliteal artery.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Pregnant or lactating females.
* Known intolerance to study medications, paclitaxel or contrast agents that in the opinion of the investigator cannot be adequately pre-treated.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
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
1/06/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2017
Sample size
Target
Accrual to date
Final
25
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Hamilton

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

Ethics approval
Ethics application status

Summary
Brief summary
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
https://clinicaltrials.gov/study/NCT01912937
Trial related presentations / publications
Gray WA, Jaff MR, Parikh SA, Ansel GM, Brodmann M, Krishnan P, Razavi MK, Vermassen F, Zeller T, White R, Ouriel K, Adelman MA, Lyden SP. Mortality Assessment of Paclitaxel-Coated Balloons: Patient-Level Meta-Analysis of the ILLUMENATE Clinical Program at 3 Years. Circulation. 2019 Oct;140(14):1145-1155. doi: 10.1161/CIRCULATIONAHA.119.040518. Epub 2019 Sep 30.
Krishnan P, Faries P, Niazi K, Jain A, Sachar R, Bachinsky WB, Cardenas J, Werner M, Brodmann M, Mustapha JA, Mena-Hurtado C, Jaff MR, Holden AH, Lyden SP. Stellarex Drug-Coated Balloon for Treatment of Femoropopliteal Disease: Twelve-Month Outcomes From the Randomized ILLUMENATE Pivotal and Pharmacokinetic Studies. Circulation. 2017 Sep 19;136(12):1102-1113. doi: 10.1161/CIRCULATIONAHA.117.028893. Epub 2017 Jul 20.
Public notes

Contacts
Principal investigator
Name 0 0
Andrew Holden, MD
Address 0 0
Auckland City Hospital
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/study/NCT01912937