Peripheral Arterial Disease (PAD)NCT00827619
Zilver® Flex™ Vascular Stent Study
A study testing Zilver® Flex™ Vascular Stent in people with Peripheral Arterial Disease (PAD), run by Cook Group Incorporated at 3 sites in Germany.
Trial summary
This study is intended to evaluate the long-term effectiveness of treatment of de novo or restenotic lesions of the above-the-knee femoropopliteal artery using the Zilver® Flex™ Vascular Stent which has received the CE mark for commercial use. The study is designed as a single arm non-randomized post-approval study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease (PAD)
- What is being tested?
- Zilver® Flex™ Vascular Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 3 sitesGermany
- Study dates
- Feb 2009to Nov 2015
- 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
- Patients who are at least 18 years old and have at least 1 stenotic atherosclerotic lesion of the above-the-knee femoropopliteal artery may be considered for enrollment.
- To be enrolled in the study, the lesion must be the appropriate size and and no prior stent in the target vessel may be present.
Who cannot join
- Patient is < 18 years of age.
- Patient is pregnant or breast-feeding.
- Patient is simultaneously participating in an investigational drug or device study. The patient must have completed the follow-up phase for the primary endpoint of any previous study at least 30 days prior to enrollment in this study.
- Patient has had previous stenting of the target vessel.
- Patient has a medical condition or disorder that would limit life expectancy to less than 1 year or that may cause noncompliance with the protocol or confound the data analysis.
- Patient in whom antiplatelet and/or anticoagulant therapy is contraindicated.
- Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
- Patient has known hypersensitivity or contraindication to aspirin, antiplatelet medication, contrast dye, or nitinol that, in the opinion of the investigator, cannot be adequately premedicated.
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Herz-Zentrum
Bad Krozingen, 79189
Gemeinschaftspraxis
Leipzig, 04177
Universitatsklinikum Magdeburg
Magdeburg, 39120
About this study
Official title: Evaluation of the Zilver® Flex™ Vascular Stent in the Above-the-Knee Femoropopliteal Artery
This study is intended to evaluate the long-term effectiveness of treatment of de novo or restenotic lesions of the above-the-knee femoropopliteal artery using the Zilver® Flex™ Vascular Stent which has received the CE mark for commercial use. The study is designed as a single arm non-randomized post-approval study.
- Conditions
- Peripheral Arterial Disease (PAD)
- Being tested
- Zilver® Flex™ Vascular Stent
- Keywords
- Peripheral Arterial Disease
- 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® Flex™ Vascular StentDevice
Also called Stenting, Vascular Stent, Implant
Stenting of the Above-the-Knee Femoropopliteal Artery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | single arm non-randomized post-market study Receives: Device: Zilver® Flex™ Vascular Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary patency of the treated lesion within the superficial femoral artery
Measured: 1 year after patient enrollment
Secondary outcomes (1)
Procedural success and primary-assisted and secondary patency, thrombosis/total occlusion rate, clinical improvement, and functional status improvement
Measured: 1 year after patient enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2009 (estimated)
- Study startFeb 2009
- Primary completionNov 2011
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Group Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jens Ricke, MD, Principal investigator, Universitatsklinikum Magdeburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00827619
- Sponsor's protocol ID
- 08-009
- Other IDs
- 100005, ZBLL
- Status last verified
- Dec 2015
- First submitted
- 22 Jan 2009
- Last updated
- 4 Dec 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Zilver® Flex™ Vascular Stent in the Above-the-Knee Femoropopliteal Artery
- ClinicalTrials.gov ID
- NCT00827619
- Acronym / sponsor ID
- 08-009
- Conditions
- Peripheral Arterial Disease (PAD)
- Keywords
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Cook Group IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 23 Jan 2009 (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.
This study is intended to evaluate the long-term effectiveness of treatment of de novo or restenotic lesions of the above-the-knee femoropopliteal artery using the Zilver® Flex™ Vascular Stent which has received the CE mark for commercial use. The study is designed as a single arm non-randomized post-approval study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Device: Zilver® Flex™ Vascular Stentsingle arm non-randomized post-market study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who are at least 18 years old and have at least 1 stenotic atherosclerotic lesion of the above-the-knee femoropopliteal artery may be considered for enrollment.
- To be enrolled in the study, the lesion must be the appropriate size and and no prior stent in the target vessel may be present.
Key exclusion criteria (8 listed)
- Patient is < 18 years of age.
- Patient is pregnant or breast-feeding.
- Patient is simultaneously participating in an investigational drug or device study. The patient must have completed the follow-up phase for the primary endpoint of any previous study at least 30 days prior to enrollment in this study.
- Patient has had previous stenting of the target vessel.
- Patient has a medical condition or disorder that would limit life expectancy to less than 1 year or that may cause noncompliance with the protocol or confound the data analysis.
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® Flex™ Vascular StentAlso: Stenting, Vascular Stent, ImplantStenting of the Above-the-Knee Femoropopliteal Artery | Device | 1 |
Primary outcome
Primary patency of the treated lesion within the superficial femoral artery
Time frame: 1 year after patient enrollment
1 secondary outcome
Procedural success and primary-assisted and secondary patency, thrombosis/total occlusion rate, clinical improvement, and functional status improvement
Time frame: 1 year after patient enrollment
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 4 Dec 2015.
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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.
Jens Ricke, MD principal investigator
Universitatsklinikum Magdeburg
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zilver® Flex™ Vascular Stent in people with Peripheral Arterial Disease (PAD), run by Cook Group Incorporated at 3 sites in Germany.
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 8 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 4 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in 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?
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 of the treated lesion within the superficial femoral artery (time frame: 1 year after patient enrollment). 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 4 Dec 2015; AzTrials last refreshed its copy on 30 Oct 2026.