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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02936622




Registration number
NCT02936622
Ethics application status
Date submitted
12/10/2016
Date registered
18/10/2016
Date last updated
5/04/2024

Titles & IDs
Public title
Paclitaxel-coated Peripheral Stents Used in the Treatment of Femoropopliteal Stenoses
Scientific title
Paclitaxel-coated Peripheral Stents Used in the Treatment of Femoropopliteal Stenoses
Secondary ID [1] 0 0
13-002
Universal Trial Number (UTN)
Trial acronym
XPEDITE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral Arterial Disease (PAD) 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 - Zilver® Paclitaxel-Eluting Peripheral Stent
Treatment: Devices - Zilver® Paclitaxel-Eluting Peripheral Stent with slower-dissolving polymer-free paclitaxel coating
Treatment: Devices - Zilver® Paclitaxel-Eluting Peripheral Stent with higher-dose polymer-free paclitaxel coating

Experimental: Stent 1 - Zilver® PTX Stent

Experimental: Stent 2 - Zilver® Paclitaxel-Eluting Peripheral Stent with slower-dissolving polymer-free paclitaxel coating

Experimental: Stent 3 - Zilver® Paclitaxel-Eluting Peripheral Stent with higher-dose polymer-free paclitaxel coating


Treatment: Devices: Zilver® Paclitaxel-Eluting Peripheral Stent
Paclitaxel belongs to the Taxane drug class and coated on the stent at a much lower dose than when administered as a chemotherapy agent.

Treatment: Devices: Zilver® Paclitaxel-Eluting Peripheral Stent with slower-dissolving polymer-free paclitaxel coating
Paclitaxel belongs to the Taxane drug class and coated on the stent at a much lower dose than when administered as a chemotherapy agent.

Treatment: Devices: Zilver® Paclitaxel-Eluting Peripheral Stent with higher-dose polymer-free paclitaxel coating
Paclitaxel belongs to the Taxane drug class and coated on the stent at a much lower dose than when administered as a chemotherapy agent.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The percent diameter stenosis within the study lesion evaluated by conventional angiography.
Timepoint [1] 0 0
6 months

Eligibility
Key inclusion criteria
* One de novo or restenosed artherosclerotic lesion with = 50% diameter stenosis
* Symptoms of peripheral arterial disease (Rutherford 2-4)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Pregnant, breastfeeding, or planning to become pregnant in the next 5 years
* Less than 18 years old
* Medical condition or disorder that would limit life expectancy to less than 12 months or that may cause noncompliance with the protocol or confound the data analysis
* Previous stent in the study vessel

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 assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
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
21/02/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/10/2023
Sample size
Target
Accrual to date
Final
176
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Arnsberg
Country [2] 0 0
Germany
State/province [2] 0 0
Bad Krozingen
Country [3] 0 0
Germany
State/province [3] 0 0
Buchholz
Country [4] 0 0
Germany
State/province [4] 0 0
Heidelberg
Country [5] 0 0
Germany
State/province [5] 0 0
Jena
Country [6] 0 0
Germany
State/province [6] 0 0
Karlsruhe
Country [7] 0 0
Germany
State/province [7] 0 0
Leipzig
Country [8] 0 0
Germany
State/province [8] 0 0
Sonneberg
Country [9] 0 0
Germany
State/province [9] 0 0
Stuttgart
Country [10] 0 0
Germany
State/province [10] 0 0
Würzburg
Country [11] 0 0
New Zealand
State/province [11] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Cook Group Incorporated
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This randomized multi-center study is intended to compare different coatings on stents for treatment of lesions of the above-the-knee femoropopliteal artery.
Trial website
https://clinicaltrials.gov/study/NCT02936622
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Thomas Zeller, Prof. Dr. med.
Address 0 0
Universitäts Herzzentrum Freiburg - Bad Krozingen
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/NCT02936622