Peripheral Arterial Disease (PAD)XPEDITENCT02936622
Paclitaxel-coated Peripheral Stents Used in the Treatment of Femoropopliteal Stenoses
A study testing Zilver® Paclitaxel-Eluting Peripheral Stent, Zilver® Paclitaxel-Eluting Peripheral Stent with slower-dissolving polymer-free paclitaxel coating and Zilver® Paclitaxel-Eluting Peripheral Stent with higher-dose polymer-free paclitaxel coating in people with Peripheral Arterial Disease (PAD), run by Cook Group Incorporated at 11 sites in 2 countries.
Trial summary
This randomized multi-center study is intended to compare different coatings on stents 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 (PAD)
- What is being tested?
- Zilver® Paclitaxel-Eluting Peripheral Stent, Zilver® Paclitaxel-Eluting Peripheral Stent with slower-dissolving polymer-free paclitaxel coating and Zilver® Paclitaxel-Eluting Peripheral Stent with higher-dose polymer-free paclitaxel coating
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 21 Feb 2017to 25 Oct 2023
- 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
- One de novo or restenosed artherosclerotic lesion with ≥ 50% diameter stenosis
- Symptoms of peripheral arterial disease (Rutherford 2-4)
Who cannot join
- Pregnant, breastfeeding, or planning to become pregnant in the next 5 years
- Less than 18 years old
- Medical condition or disorder that would limit life expectancy to less than 12 months or that may cause noncompliance with the protocol or confound the data analysis
- Previous stent in the study vessel
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
Germany10 sites
Klinikum Hochsauerland
Arnsberg, 59759
Universitäts Herzzentrum Freiburg - Bad Krozingen
Bad Krozingen, 79189
Krankenhaud Bucholz
Buchholz, 21244
St. Josefskrankenhaus Heidelberg
Heidelberg, 69115
Universitätsklinikum Jena
Jena, 07747
SRH Klinikum Karlsbad- Langensteinbach GmbH
Karlsruhe, 76307
Universitatsklinikum Leipzig AoR
Leipzig, 04103
MEDINOS Kliniken des Landkreises Sonneberg GmbH
Sonneberg, 96515
Marienhospital Stuttgart
Stuttgart, 70199
Uniklinikum Würzburg
Würzburg, 70199
About this study
This randomized multi-center study is intended to compare different coatings on stents for treatment of lesions of the above-the-knee femoropopliteal artery.
- Conditions
- Peripheral Arterial Disease (PAD)
- Being tested
- Zilver® Paclitaxel-Eluting Peripheral Stent, Zilver® Paclitaxel-Eluting Peripheral Stent with slower-dissolving polymer-free paclitaxel coating, Zilver® Paclitaxel-Eluting Peripheral Stent with higher-dose polymer-free paclitaxel coating
- 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® Paclitaxel-Eluting Peripheral StentDevice
Paclitaxel belongs to the Taxane drug class and coated on the stent at a much lower dose than when administered as a chemotherapy agent.
Zilver® Paclitaxel-Eluting Peripheral Stent with slower-dissolving polymer-free paclitaxel coatingDevice
Paclitaxel belongs to the Taxane drug class and coated on the stent at a much lower dose than when administered as a chemotherapy agent.
Zilver® Paclitaxel-Eluting Peripheral Stent with higher-dose polymer-free paclitaxel coatingDevice
Paclitaxel belongs to the Taxane drug class and coated on the stent at a much lower dose than when administered as a chemotherapy agent.
| Study group | Role | What they receive |
|---|---|---|
| Stent 1 | Experimental | Zilver® PTX Stent Receives: Device: Zilver® Paclitaxel-Eluting Peripheral Stent |
| Stent 2 | Experimental | Zilver® Paclitaxel-Eluting Peripheral Stent with slower-dissolving polymer-free paclitaxel coating Receives: Device: Zilver® Paclitaxel-Eluting Peripheral Stent with slower-dissolving polymer-free paclitaxel coating |
| Stent 3 | Experimental | Zilver® Paclitaxel-Eluting Peripheral Stent with higher-dose polymer-free paclitaxel coating Receives: Device: Zilver® Paclitaxel-Eluting Peripheral Stent with higher-dose polymer-free paclitaxel coating |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percent diameter stenosis within the study lesion evaluated by conventional angiography.
Percent diameter stenosis will be calculated by comparing the minimal lumen diameter to the average of the proximal and distal reference vessel diameters.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study start21 Feb 2017
- Primary completion23 Apr 2019
- Study completion25 Oct 2023
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Group Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Zeller, Prof. Dr. med., Principal investigator, Universitäts Herzzentrum Freiburg - Bad Krozingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02936622
- Sponsor's protocol ID
- 13-002
- Acronym
- XPEDITE
- Status last verified
- Apr 2024
- First submitted
- 12 Oct 2016
- Last updated
- 5 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paclitaxel-coated Peripheral Stents Used in the Treatment of Femoropopliteal Stenoses
- ClinicalTrials.gov ID
- NCT02936622
- Acronym / sponsor ID
- XPEDITE / 13-002
- Conditions
- Peripheral Arterial Disease (PAD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Cook Group IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 21 Feb 2017 (actual)
- Primary completion
- 23 Apr 2019 (actual)
- Study completion
- 25 Oct 2023 (actual)
- First posted
- 18 Oct 2016 (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 randomized multi-center study is intended to compare different coatings on stents for treatment of lesions of the above-the-knee femoropopliteal artery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stent 1 | Experimental | Device: Zilver® Paclitaxel-Eluting Peripheral StentZilver® PTX Stent |
| Stent 2 | Experimental | Device: Zilver® Paclitaxel-Eluting Peripheral Stent with slower-dissolving polymer-free paclitaxel coatingZilver® Paclitaxel-Eluting Peripheral Stent with slower-dissolving polymer-free paclitaxel coating |
| Stent 3 | Experimental | Device: Zilver® Paclitaxel-Eluting Peripheral Stent with higher-dose polymer-free paclitaxel coatingZilver® Paclitaxel-Eluting Peripheral Stent with higher-dose polymer-free paclitaxel coating |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- One de novo or restenosed artherosclerotic lesion with ≥ 50% diameter stenosis
- Symptoms of peripheral arterial disease (Rutherford 2-4)
Key exclusion criteria (4 listed)
- Pregnant, breastfeeding, or planning to become pregnant in the next 5 years
- Less than 18 years old
- Medical condition or disorder that would limit life expectancy to less than 12 months or that may cause noncompliance with the protocol or confound the data analysis
- Previous stent in the study vessel
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® Paclitaxel-Eluting Peripheral StentPaclitaxel belongs to the Taxane drug class and coated on the stent at a much lower dose than when administered as a chemotherapy agent. | Device | Stent 1 |
| Zilver® Paclitaxel-Eluting Peripheral Stent with slower-dissolving polymer-free paclitaxel coatingPaclitaxel belongs to the Taxane drug class and coated on the stent at a much lower dose than when administered as a chemotherapy agent. | Device | Stent 2 |
| Zilver® Paclitaxel-Eluting Peripheral Stent with higher-dose polymer-free paclitaxel coatingPaclitaxel belongs to the Taxane drug class and coated on the stent at a much lower dose than when administered as a chemotherapy agent. | Device | Stent 3 |
Primary outcome
The percent diameter stenosis within the study lesion evaluated by conventional angiography.
Time frame: 6 months
Percent diameter stenosis will be calculated by comparing the minimal lumen diameter to the average of the proximal and distal reference vessel diameters.
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 5 Apr 2024.
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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.
Thomas Zeller, Prof. Dr. med. principal investigator
Universitäts Herzzentrum Freiburg - Bad Krozingen
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zilver® Paclitaxel-Eluting Peripheral Stent, Zilver® Paclitaxel-Eluting Peripheral Stent with slower-dissolving polymer-free paclitaxel coating and Zilver® Paclitaxel-Eluting Peripheral Stent with higher-dose polymer-free paclitaxel coating in people with Peripheral Arterial Disease (PAD), run by Cook Group Incorporated at 11 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 2 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 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany, New Zealand. 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?
The percent diameter stenosis within the study lesion evaluated by conventional angiography. (time frame: 6 months). 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 5 Apr 2024.