Peripheral Artery DiseaseNCT02171962
Zilver® PTX® in China
A study testing Zilver® PTX® Drug-Eluting Peripheral Stent in people with Peripheral Artery Disease, run by Cook Group Incorporated at 9 sites in China.
Trial summary
The objective of this study is to evaluate the Zilver® PTX® Drug-Eluting Peripheral Stent for treatment of lesions of the above-the-knee femoropopliteal artery in a Chinese patient population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery 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
- 178 participants
- Where
- 9 sitesChina
- Study dates
- Jun 2014to 9 Feb 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptoms of peripheral arterial disease corresponding to Rutherford Classification 2-4
- Stenotic (>50% diameter stenosis) or occluded lesion of the above-the knee femoropopliteal artery
- Reference vessel diameter of 4-9 mm
- Lesion length up to 140 mm
Who cannot join
- Unsuccessful arterial interventional treatment of the legs within 30 days prior to the study procedure
- Previous stent in the study vessel
- Bypass graft with an anastomosis in the study vessel
- Significant stenosis or occlusion of inflow tract not successfully treated prior to treating the study lesion
- No patent vessel of runoff
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites
Beijing Anzhen Hospital
Beijing, 100029
China-Japan Friendship Hospital
Beijing, 100029
Peking University First Hospital
Beijing, 100034
Peking University People's Hospital
Beijing, 100044
Peking Union Medical College Hospital
Beijing, 100730
Chinese PLA General Hospital
Beijing, 100853
Shanghai Ninth People's Hospital Affiliated Shanghai JiaoTong University School of Medicine
Shanghai, 200011
Zhongshan Hospital Fudan University
Shanghai, 200032
Renji Hospital Shanghai Jiaotong University School of Medicine
Shanghai, 200127
About this study
Official title: Evaluation of the Zilver® PTX® Drug-Eluting Peripheral Stent for Treatment of Lesions of the Above-the-Knee Femoropopliteal Artery
The objective of this study is to evaluate the Zilver® PTX® Drug-Eluting Peripheral Stent for treatment of lesions of the above-the-knee femoropopliteal artery in a Chinese patient population.
- Conditions
- Peripheral Artery Disease
- Being tested
- Zilver® PTX® Drug-Eluting Peripheral Stent
- Keywords
- Zilver® PTX® Drug-Eluting Peripheral Stent, Above-the-Knee Femoropopliteal Artery, Chinese patient
- 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 Peripheral StentDevice
Zilver® PTX® Drug-Eluting Peripheral Stent for treatment of lesions of the above-the-knee femoropopliteal artery
| Study group | Role | What they receive |
|---|---|---|
| Zilver® PTX® VI | 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.
Primary Patency as Assessed by Duplex Ultrasonography
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2015
- Study completion9 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peripheral Artery 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
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Group Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Dake, MD, Study director, Stanford University, CA, USAChangwei Liu, MD, Principal investigator, Peking Union Medical College Hospital, Beijing, ChinaWeiguo Fu, MD, Principal investigator, Zhongshan Hospital Fudan University, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02171962
- Sponsor's protocol ID
- 13-008
- Status last verified
- Mar 2017
- First submitted
- 18 Jun 2014
- Last updated
- 22 Mar 2017
- Results posted
- No
Publications
Ye W, Bohme T, Fu W, Liu C, Zhang X, Liu P, Zhang J, Zou Y, Lu X, Lottes AE, O'Leary EE, Zeller T, Dake MD. First peripheral drug-eluting stent clinical results from China: 1-year outcomes of the Zilver PTX China study. Front Cardiovasc Med. 2022 Sep 27;9:877578. doi: 10.3389/fcvm.2022.877578. eCollection 2022.
PubMed 36237908Dake 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 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Zilver® PTX® Drug-Eluting Peripheral Stent for Treatment of Lesions of the Above-the-Knee Femoropopliteal Artery
- ClinicalTrials.gov ID
- NCT02171962
- Acronym / sponsor ID
- 13-008
- Conditions
- Peripheral Artery Disease
- Keywords
- Zilver® PTX® Drug-Eluting Peripheral Stent, Above-the-Knee Femoropopliteal Artery, Chinese patient
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Cook Group IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- 9 Feb 2017 (actual)
- First posted
- 24 Jun 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.
The objective of this study is to evaluate the Zilver® PTX® Drug-Eluting Peripheral Stent for treatment of lesions of the above-the-knee femoropopliteal artery in a Chinese patient population.
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® VI | 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 (4 listed)
- Symptoms of peripheral arterial disease corresponding to Rutherford Classification 2-4
- Stenotic (>50% diameter stenosis) or occluded lesion of the above-the knee femoropopliteal artery
- Reference vessel diameter of 4-9 mm
- Lesion length up to 140 mm
Key exclusion criteria (5 listed)
- Unsuccessful arterial interventional treatment of the legs within 30 days prior to the study procedure
- Previous stent in the study vessel
- Bypass graft with an anastomosis in the study vessel
- Significant stenosis or occlusion of inflow tract not successfully treated prior to treating the study lesion
- No patent vessel of runoff
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 StentZilver® PTX® Drug-Eluting Peripheral Stent for treatment of lesions of the above-the-knee femoropopliteal artery | Device | Zilver® PTX® VI |
Primary outcome
Primary Patency as Assessed by Duplex Ultrasonography
Time frame: 12 months
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 22 Mar 2017.
- Derived from this study: PubMed 36237908Ye W, Bohme T, Fu W, Liu C, Zhang X, Liu P, Zhang J, Zou Y, Lu X, Lottes AE, O'Leary EE, Zeller T, Dake MD. First peripheral drug-eluting stent clinical results from China: 1-year outcomes of the Zilver PTX China study. Front Cardiovasc Med. 2022 Sep 27;9:877578. doi: 10.3389/fcvm.2022.877578. eCollection 2022.
- 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.
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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 Dake, MD study director
Stanford University, CA, USA
Changwei Liu, MD principal investigator
Peking Union Medical College Hospital, Beijing, China
Weiguo Fu, MD principal investigator
Zhongshan Hospital Fudan University, Shanghai, China
9 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 Artery Disease, run by Cook Group Incorporated at 9 sites in China.
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 5 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 22 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. 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?
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?
Primary Patency as Assessed by Duplex Ultrasonography (time frame: 12 months). 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 NCT02171962, which also lists 2 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 22 Mar 2017.