Peripheral Arterial DiseaseNCT01348425
Zilver PTX Drug-Eluting Peripheral Stent Study
A study testing Longer Zilver PTX Stents and Shorter Zilver PTX Stents in people with Peripheral Arterial Disease, run by Cook Group Incorporated at 4 sites in 2 countries.
Trial summary
This randomized, post-market clinical study is intended to evaluate the delivery and deployment of longer Zilver PTX stents (≥ 100 mm) compared to shorter Zilver PTX stents (≤80 mm) for treatment of lesions of the above-the-knee femoropopliteal artery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Longer Zilver PTX Stents and Shorter Zilver PTX Stents
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 4 sitesin 2 countries
- Study dates
- May 2011to Sep 2012
- 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
- One de novo or restenosed artherosclerotic lesion with > 50% diameter stenosis
- Reference vessel diameter of 4 - 9 mm
- Rutherford category ≥ 2
- Resting ankle brachial index < 0.9
Who cannot join
- Prior stent in the study vessel
- Significant stenosis (> 50%) or occlusion of inflow tract not successfully treated before the study procedure
- Lacks at least one patent runoff vessel
- Lesions requiring atherectomy, cutting balloons, cryoplasty balloons, or any other advanced device to facilitate stent delivery
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Germany3 sites
Herz-Zentrum
Bad Krozingen, 79189
Evangelische Krankenhaus Königin Elisabeth Herzberge
Berlin, 10365
Universitätsklinikum Magdeburg A.ö.R.
Magdeburg, 39120
About this study
Official title: Evaluation of the Zilver PTX Drug-Eluting Peripheral Stent
This randomized, post-market clinical study is intended to evaluate the delivery and deployment of longer Zilver PTX stents (≥ 100 mm) compared to shorter Zilver PTX stents (≤80 mm) for treatment of lesions of the above-the-knee femoropopliteal artery.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Longer Zilver PTX Stents, Shorter Zilver PTX Stents
- Keywords
- PAD
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Longer Zilver PTX StentsDevice
Treatment with at least one 100 mm or longer Zilver PTX stent
Shorter Zilver PTX StentsDevice
Treatment with Zilver PTX stents 80 mm or shorter only
| Study group | Role | What they receive |
|---|---|---|
| Longer Stents | Experimental | Not described Receives: Device: Longer Zilver PTX Stents |
| Shorter Stents | Experimental | Not described Receives: Device: Shorter Zilver PTX Stents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Stent Length Upon Deployment
Measured: During Procedure (day 1) (Prior to Stent Deployment and after Stent Deployment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2011 (estimated)
- Study startMay 2011
- Primary completionOct 2011
- Study completionSep 2012
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 Arterial 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Group Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prof. Dr. med. Jens Ricke, Principal investigator, Universitätsklinikum Magdeburg A.ö.R., Department for Radiology and Nuclear Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01348425
- Sponsor's protocol ID
- 11-003
- Status last verified
- Mar 2014
- First submitted
- 29 Apr 2011
- Last updated
- 2 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Zilver PTX Drug-Eluting Peripheral Stent
- ClinicalTrials.gov ID
- NCT01348425
- Acronym / sponsor ID
- 11-003
- Conditions
- Peripheral Arterial Disease
- Keywords
- PAD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Cook Group IncorporatedIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 5 May 2011 (estimated)
- Results
- Posted 16 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized, post-market clinical study is intended to evaluate the delivery and deployment of longer Zilver PTX stents (≥ 100 mm) compared to shorter Zilver PTX stents (≤80 mm) for treatment of lesions of the above-the-knee femoropopliteal artery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Longer Stents | Experimental | Device: Longer Zilver PTX Stents |
| Shorter Stents | Experimental | Device: Shorter Zilver PTX Stents |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- One de novo or restenosed artherosclerotic lesion with > 50% diameter stenosis
- Reference vessel diameter of 4 - 9 mm
- Rutherford category ≥ 2
- Resting ankle brachial index < 0.9
Key exclusion criteria (4 listed)
- Prior stent in the study vessel
- Significant stenosis (> 50%) or occlusion of inflow tract not successfully treated before the study procedure
- Lacks at least one patent runoff vessel
- Lesions requiring atherectomy, cutting balloons, cryoplasty balloons, or any other advanced device to facilitate stent delivery
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 |
|---|---|---|
| Longer Zilver PTX StentsTreatment with at least one 100 mm or longer Zilver PTX stent | Device | Longer Stents |
| Shorter Zilver PTX StentsTreatment with Zilver PTX stents 80 mm or shorter only | Device | Shorter Stents |
Primary outcome
Percent Change in Stent Length Upon Deployment
Time frame: During Procedure (day 1) (Prior to Stent Deployment and after Stent Deployment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 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.
Prof. Dr. med. Jens Ricke principal investigator
Universitätsklinikum Magdeburg A.ö.R., Department for Radiology and Nuclear Medicine
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Longer Zilver PTX Stents and Shorter Zilver PTX Stents in people with Peripheral Arterial Disease, run by Cook Group Incorporated at 4 sites in 2 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 4 inclusion and 4 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 2 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 4 sites in Germany, Switzerland. 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 16 Apr 2014). 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?
Percent Change in Stent Length Upon Deployment (time frame: During Procedure (day 1) (Prior to Stent Deployment and after Stent Deployment)). 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 2 Feb 2016; AzTrials last refreshed its copy on 31 Oct 2026.