Peripheral Arterial DiseaseNCT01901289
Zilver® PTX® V Clinical Study
A study testing Zilver® PTX® Drug-Eluting Peripheral Stent in people with Peripheral Arterial Disease, run by Cook Research Incorporated at 17 sites in United States.
Trial summary
The Zilver® PTX® V Clinical Study is a post-market clinical trial required by the US FDA to provide continued evaluation of the safety and effectiveness of the Zilver PTX Drug-Eluting Peripheral Stent in treatment of narrowing of the femoropopliteal arteries. 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?
- 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
- 200 participants
- Where
- 17 sitesUnited States
- Study dates
- Aug 2013to 15 Feb 2021
- 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 signed and dated the informed consent.
- Patient has symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.
- Patient agrees to return for the required follow-up assessments.
Who cannot join
- Patient is < 18 years of age.
- Patient has significant stenosis of inflow tract not successfully treated before this procedure.
- Patient lacks at least one patent vessel of runoff with < 50% stenosis throughout its course.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Bayview Medical Center
Baltimore, Maryland, 21224
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Holy Spirit Hospital
Camp Hill, Pennsylvania, 17011
South Carolina Heart Center
Columbia, South Carolina, 29204
OhioHealth Research Institute
Columbus, Ohio, 43214
Alexian Brothers Medical Center
Elk Grove Village, Illinois, 60007
The Cardiac and Vascular Institute
Gainesville, Florida, 32605
University of Florida
Gainesville, Florida, 32610
Greenville Hospital System
Greenville, South Carolina, 29615
First Coast Cardiovascular Institute
Jacksonville, Florida, 32216
Holston Valley Hospital
Kingsport, Tennessee, 37660
Columbia University Medical Center
New York, New York, 10032
New York-Presbyterian/ Weill Cornell Medical Center
New York, New York, 10065
VA Palo Alto Health Care System
Palo Alto, California, 94304
Stanford University Medical School
Stanford, California, 94305
University of Toledo Medical Center
Toledo, Ohio, 43614
Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Zilver® PTX® Drug-Eluting Peripheral Stent Post-Approval Study
The Zilver® PTX® V Clinical Study is a post-market clinical trial required by the US FDA to provide continued evaluation of the safety and effectiveness of the Zilver PTX Drug-Eluting Peripheral Stent in treatment of narrowing of the femoropopliteal arteries.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Zilver® PTX® Drug-Eluting Peripheral Stent
- Keywords
- Peripheral Vascular Disease, Femoral Artery, Popliteal Artery, Drug-Eluting Stent
- Medical subject headings
- Peripheral Arterial Disease, 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 | Not described 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.
Patients Without Target Lesion Revascularization (TLR)
A reintervention performed for ≥ 50 % diameter stenosis within ± 5 mm proximal and /or distal to the target lesion after documentation of recurrent clinical symptoms of peripheral arterial disease (PAD) following the initial procedure.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2013 (estimated)
- Study startAug 2013
- Primary completion18 Nov 2016
- Study completion15 Feb 2021
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Research Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01901289
- Sponsor's protocol ID
- 12-004
- Status last verified
- Feb 2022
- First submitted
- 8 Jul 2013
- Last updated
- 2 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- Individual data sharing
- Undecided: Cook Research Incorporated (CRI) is fully committed to supporting the principles of responsible data sharing, including providing qualified scientific researchers access to deidentified, patient-level data from CRI clinical studies to conduct legitimate scientific research. Data underlying the results reported in this clinical study will be made available for request after final report has been distributed and ending 5 years after final report has been distributed. Interested researchers may review the "Cook Research Incorporated Policy on Access to Clinical Study Data" at https://www.cookresearchinc.com/extranet/data-access.html and submit a complete research proposal to request data access. Additional study documents (such as the study protocol) will be shared as needed if the data access request is granted. A data sharing agreement will be executed for access to deidentified patient-level data.
Publications
Dake MD, Fanelli F, Lottes AE, O'Leary EE, Reichert H, Jiang X, Fu W, Iida O, Zen K, Schermerhorn M, Zeller T, Ansel GM. Prediction Model for Freedom from TLR from a Multi-study Analysis of Long-Term Results with the Zilver PTX Drug-Eluting Peripheral Stent. Cardiovasc Intervent Radiol. 2021 Feb;44(2):196-206. doi: 10.1007/s00270-020-02648-6. Epub 2020 Oct 6.
PubMed 33025243
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zilver® PTX® Drug-Eluting Peripheral Stent Post-Approval Study
- ClinicalTrials.gov ID
- NCT01901289
- Acronym / sponsor ID
- 12-004
- Conditions
- Peripheral Arterial Disease
- Keywords
- Peripheral Vascular Disease, Femoral Artery, Popliteal Artery, Drug-Eluting Stent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Cook Research IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- 18 Nov 2016 (actual)
- Study completion
- 15 Feb 2021 (actual)
- First posted
- 17 Jul 2013 (estimated)
- Results
- Posted 3 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Zilver® PTX® V Clinical Study is a post-market clinical trial required by the US FDA to provide continued evaluation of the safety and effectiveness of the Zilver PTX Drug-Eluting Peripheral Stent in treatment of narrowing of the femoropopliteal arteries.
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 Stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient has signed and dated the informed consent.
- Patient has symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.
- Patient agrees to return for the required follow-up assessments.
Key exclusion criteria (3 listed)
- Patient is < 18 years of age.
- Patient has significant stenosis of inflow tract not successfully treated before this procedure.
- Patient lacks at least one patent vessel of runoff with < 50% stenosis throughout its course.
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
Patients Without Target Lesion Revascularization (TLR)
Time frame: 1 year
A reintervention performed for ≥ 50 % diameter stenosis within ± 5 mm proximal and /or distal to the target lesion after documentation of recurrent clinical symptoms of peripheral arterial disease (PAD) following the initial procedure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33025243Dake MD, Fanelli F, Lottes AE, O'Leary EE, Reichert H, Jiang X, Fu W, Iida O, Zen K, Schermerhorn M, Zeller T, Ansel GM. Prediction Model for Freedom from TLR from a Multi-study Analysis of Long-Term Results with the Zilver PTX Drug-Eluting Peripheral Stent. Cardiovasc Intervent Radiol. 2021 Feb;44(2):196-206. doi: 10.1007/s00270-020-02648-6. Epub 2020 Oct 6.
- Individual participant dataSharing planned: Undecided. Cook Research Incorporated (CRI) is fully committed to supporting the principles of responsible data sharing, including providing qualified scientific researchers access to deidentified, patient-level data from CRI clinical studies to conduct legitimate scientific research. Data underlying the results reported in this clinical study will be made available for request after final report has been distributed and ending 5 years after final report has been distributed. Interested researchers may review the "Cook Research Incorporated Policy on Access to Clinical Study Data" at https://www.cookresearchinc.com/extranet/data-access.html and submit a complete research proposal to request data access. Additional study documents (such as the study protocol) will be shared as needed if the data access request is granted. A data sharing agreement will be executed for access to deidentified patient-level data.
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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.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 1 country: 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 Arterial Disease, run by Cook Research Incorporated at 17 sites in United States.
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 3 inclusion and 3 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 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. 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 3 Jul 2018). 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?
Patients Without Target Lesion Revascularization (TLR) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01901289, which also lists 1 linked publication.
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 Mar 2022.