Peripheral Vascular DiseaseNCT02271529
Zilver PTX Delivery System
A study testing Zilver® PTX® Drug-Eluting Peripheral Stent in people with Peripheral Vascular Disease, run by Cook Group Incorporated at 6 sites in 3 countries.
Trial summary
The objective of this study is to evaluate the performance of the Zilver PTX stent thumbwheel delivery system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Vascular Disease
- What is being tested?
- Zilver® PTX® Drug-Eluting Peripheral Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 6 sitesin 3 countries
- Study dates
- Sep 2014to May 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has symptomatic vascular disease of the native above-the-knee femoropopliteal arteries
- Patient has atherosclerotic lesion of the above-the-knee femoropopliteal artery
Who cannot join
- Patient is < 18 years of age
- Patient unable to complete required follow-up assessments
- Patient unwilling to sign and date the informed consent
- Simultaneous participation in another investigational drug or device study
- Pregnant, breastfeeding or planning to become pregnant in the next 5 years
- Additional medical/anatomical restrictions as specified in the Clinical Investigation Plan
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
New Zealand3 sites
Auckland City Hospital
Auckland, 1023
Waikato Hospital
Hamilton, 3248
Wellington Hospital
Wellington, 3248
Australia2 sites
Frankston Hospital
Frankston, Vic 3199
Princess Alexandra Hospital
Woolloongabba, Qld 4102
Germany1 site
Universitäts-Herzzentrum Freiburg - Bad Krozingen GmbH
Bad Krozingen, D-79189
About this study
Official title: Zilver Paclitaxel(PTX) Thumbwheel Delivery System
The objective of this study is to evaluate the performance of the Zilver PTX stent thumbwheel delivery system.
- Conditions
- Peripheral Vascular Disease
- Being tested
- Zilver® PTX® Drug-Eluting Peripheral Stent
- Keywords
- Peripheral Vascular Disease, Femoral Artery, Drug-Eluting Stent
- Medical subject headings
- Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zilver® PTX® Drug-Eluting Peripheral StentDevice
Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.
| Study group | Role | What they receive |
|---|---|---|
| Drug Eluting Stent | Experimental | Zilver® Paclitaxel(PTX)® Drug-Eluting Peripheral Stent Receives: Device: Zilver® PTX® Drug-Eluting Peripheral Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Percent Change in Stent Length Upon Deployment
Measured: Immediately following completion of the stent placement procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peripheral Vascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Group Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Holden, MD, Principal investigator, Auckland District Health Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02271529
- Sponsor's protocol ID
- 13-14
- Status last verified
- Jan 2016
- First submitted
- 17 Oct 2014
- Last updated
- 26 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zilver Paclitaxel(PTX) Thumbwheel Delivery System
- ClinicalTrials.gov ID
- NCT02271529
- Acronym / sponsor ID
- 13-14
- Conditions
- Peripheral Vascular Disease
- Keywords
- Peripheral Vascular Disease, Femoral Artery, Drug-Eluting Stent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cook Group IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 22 Oct 2014 (estimated)
- Results
- Posted 26 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the performance of the Zilver PTX stent thumbwheel delivery system.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Drug Eluting Stent | Experimental | Device: Zilver® PTX® Drug-Eluting Peripheral StentZilver® Paclitaxel(PTX)® Drug-Eluting Peripheral Stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient has symptomatic vascular disease of the native above-the-knee femoropopliteal arteries
- Patient has atherosclerotic lesion of the above-the-knee femoropopliteal artery
Key exclusion criteria (6 listed)
- Patient is < 18 years of age
- Patient unable to complete required follow-up assessments
- Patient unwilling to sign and date the informed consent
- Simultaneous participation in another investigational drug or device study
- Pregnant, breastfeeding or planning to become pregnant in the next 5 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zilver® PTX® Drug-Eluting Peripheral StentTreatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries. | Device | Drug Eluting Stent |
Primary outcome
Mean Percent Change in Stent Length Upon Deployment
Time frame: Immediately following completion of the stent placement procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Holden, MD principal investigator
Auckland District Health Board
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zilver® PTX® Drug-Eluting Peripheral Stent in people with Peripheral Vascular Disease, run by Cook Group Incorporated at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in New Zealand, Australia, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Percent Change in Stent Length Upon Deployment (time frame: Immediately following completion of the stent placement procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2016.