Peripheral Arterial Disease (PAD)NCT02254837
Zilver PTX Post-Market Study in Japan
A study testing Zilver PTX Drug-Eluting Stent in people with Peripheral Arterial Disease (PAD), run by Cook Group Incorporated.
Trial summary
Japanese post market clinical study of the Zilver PTX device. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peripheral Arterial Disease (PAD)
- What is being tested?
- Zilver PTX Drug-Eluting Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 909 participants
- Where
- No sites listed yet
- Study dates
- May 2012to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Symptomatic peripheral arterial disease (PAD) involving the above-the-knee femoropopliteal arteries
Who cannot join
None listed.
About this study
Official title: Zilver PTX Post-Market Surveillance Study of Paclitaxel-Eluting Stents for Treating Femoropopliteal Artery Disease in Japan
Japanese post market clinical study of the Zilver PTX device.
- Conditions
- Peripheral Arterial Disease (PAD)
- Being tested
- Zilver PTX Drug-Eluting Stent
- 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.
Zilver PTX Drug-Eluting StentDevice
| Study group | Role | What they receive |
|---|---|---|
| Zilver PTX | Experimental | Not described Receives: Device: Zilver PTX Drug-Eluting Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of stent fracture
Measured: 5 years
Rate of adverse events
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2014 (estimated)
- Study startMay 2012
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial Disease (PAD)Studies 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
- 909 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Group Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael D Dake, MD, Principal investigator, Department of Cardiothoracic Surgery, Stanford University Medical Center, Stanford, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02254837
- Sponsor's protocol ID
- 12-005-PTX
- Status last verified
- Jul 2019
- First submitted
- 24 Sep 2014
- Last updated
- 12 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sugimoto M, Komori K, Yokoi H, Ohki T, Kichikawa K, Nakamura M, Nanto S, O'Leary EE, Lottes AE, Saunders AT, Dake MD. Long-Term Effectiveness of a Drug-Eluting Stent for Femoropopliteal In-Stent Restenosis: Subanalysis of the Zilver PTX Japan Post-Market Surveillance Study. J Endovasc Ther. 2021 Apr;28(2):229-235. doi: 10.1177/1526602820966708. Epub 2020 Oct 21.
PubMed 33084502Dake 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 33025243Kichikawa K, Ichihashi S, Yokoi H, Ohki T, Nakamura M, Komori K, Nanto S, O'Leary EE, Lottes AE, Snyder SA, Dake MD. Zilver PTX Post-market Surveillance Study of Paclitaxel-Eluting Stents for Treating Femoropopliteal Artery Disease in Japan: 2-Year Results. Cardiovasc Intervent Radiol. 2019 Mar;42(3):358-364. doi: 10.1007/s00270-018-2110-1. Epub 2018 Nov 8.
PubMed 30411151Yokoi H, Ohki T, Kichikawa K, Nakamura M, Komori K, Nanto S, O'Leary EE, Lottes AE, Snyder SA, Dake MD. Zilver PTX Post-Market Surveillance Study of Paclitaxel-Eluting Stents for Treating Femoropopliteal Artery Disease in Japan: 12-Month Results. JACC Cardiovasc Interv. 2016 Feb 8;9(3):271-277. doi: 10.1016/j.jcin.2015.09.035.
PubMed 26847118
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zilver PTX Post-Market Surveillance Study of Paclitaxel-Eluting Stents for Treating Femoropopliteal Artery Disease in Japan
- ClinicalTrials.gov ID
- NCT02254837
- Acronym / sponsor ID
- 12-005-PTX
- Conditions
- Peripheral Arterial Disease (PAD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 909 participants (actual)
- Lead sponsor
- Cook Group IncorporatedIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 2 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Japanese post market clinical study of the Zilver PTX device.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zilver PTX | Experimental | Device: Zilver PTX Drug-Eluting Stent |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Symptomatic peripheral arterial disease (PAD) involving the above-the-knee femoropopliteal arteries
Key exclusion criteria (0 listed)
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 Stent | Device | Zilver PTX |
Primary outcome
Occurrence of stent fracture
Time frame: 5 years
Rate of adverse events
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2019.
- Derived from this study: PubMed 33084502Sugimoto M, Komori K, Yokoi H, Ohki T, Kichikawa K, Nakamura M, Nanto S, O'Leary EE, Lottes AE, Saunders AT, Dake MD. Long-Term Effectiveness of a Drug-Eluting Stent for Femoropopliteal In-Stent Restenosis: Subanalysis of the Zilver PTX Japan Post-Market Surveillance Study. J Endovasc Ther. 2021 Apr;28(2):229-235. doi: 10.1177/1526602820966708. Epub 2020 Oct 21.
- 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.
- Derived from this study: PubMed 30411151Kichikawa K, Ichihashi S, Yokoi H, Ohki T, Nakamura M, Komori K, Nanto S, O'Leary EE, Lottes AE, Snyder SA, Dake MD. Zilver PTX Post-market Surveillance Study of Paclitaxel-Eluting Stents for Treating Femoropopliteal Artery Disease in Japan: 2-Year Results. Cardiovasc Intervent Radiol. 2019 Mar;42(3):358-364. doi: 10.1007/s00270-018-2110-1. Epub 2018 Nov 8.
- Derived from this study: PubMed 26847118Yokoi H, Ohki T, Kichikawa K, Nakamura M, Komori K, Nanto S, O'Leary EE, Lottes AE, Snyder SA, Dake MD. Zilver PTX Post-Market Surveillance Study of Paclitaxel-Eluting Stents for Treating Femoropopliteal Artery Disease in Japan: 12-Month Results. JACC Cardiovasc Interv. 2016 Feb 8;9(3):271-277. doi: 10.1016/j.jcin.2015.09.035.
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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.
Michael D Dake, MD principal investigator
Department of Cardiothoracic Surgery, Stanford University Medical Center, Stanford, CA
Questions about this trial
What is this clinical trial studying?
A study testing Zilver PTX Drug-Eluting Stent in people with Peripheral Arterial Disease (PAD), run by Cook Group Incorporated.
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 1 inclusion and 0 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 12 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Occurrence of stent fracture (time frame: 5 years). The study lists 2 primary outcomes in all. 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 NCT02254837, which also lists 4 linked publications.
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 12 Jul 2019.