Vascular DiseasesNCT05296031
Drug Eluting Stent Zilver PTX vs Bare Metal Stent Zilver Flex
A study testing Treatment with Zilver PTX Drug Eluting Stent (DES) in femoropopliteal lesions and Treatment with Zilver Flex Bare Metal Stent (BMS) in femoropopliteal lesions in people with Vascular Diseases, run by Skane University Hospital.
Trial summary
Randomized study comparing the results between drug-eluting stents and standard bare metal stents, when treating femoropopliteal lesions in patients with critical limb ischemia. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Vascular Diseases
- What is being tested?
- Treatment with Zilver PTX Drug Eluting Stent (DES) in femoropopliteal lesions and Treatment with Zilver Flex Bare Metal Stent (BMS) in femoropopliteal lesions
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2013to 31 Aug 2019
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Critical limb ischemia RC 4-6
- Lesions in superficial femoral artery and popliteal artery (p1 -p2)
- Target vessel 4-8mm
- At least I 1 vessel runoff to the foot
- Age >18 years
Who cannot join
- Pregnancy
- Patient disapproval
- Age <18 years
About this study
Official title: Randomized Trial Comparing Drug Eluting Stent Zilver PTX vs Bare Metal Stent Zilver Flex in Critical Limb Ischemia and Treatment of Lesions in Femoral and Popliteal Arteries"
Randomized study comparing the results between drug-eluting stents and standard bare metal stents, when treating femoropopliteal lesions in patients with critical limb ischemia.
- Conditions
- Vascular Diseases
- Being tested
- Treatment with Zilver PTX Drug Eluting Stent (DES) in femoropopliteal lesions, Treatment with Zilver Flex Bare Metal Stent (BMS) in femoropopliteal lesions
- Medical subject headings
- Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with Zilver PTX Drug Eluting Stent (DES) in femoropopliteal lesionsDevice
Randomized trial comparing drug eluting stent Zilver PTX vs Bare metal stent Zilver Flex in critical limb ischemia and treatment of lesions in femoral and popliteal arteries
Treatment with Zilver Flex Bare Metal Stent (BMS) in femoropopliteal lesionsDevice
Randomized trial comparing drug eluting stent Zilver PTX vs Bare metal stent Zilver Flex in critical limb ischemia and treatment of lesions in femoral and popliteal arteries
| Study group | Role | What they receive |
|---|---|---|
| Drug Eluting Stent (DES) | Active comparator | Drug Eluting Stent (DES). Zilver PTX. Receives: Device: Treatment with Zilver PTX Drug Eluting Stent (DES) in femoropopliteal lesions |
| Bare Metal Stent (BMS) | Placebo comparator | Bare Metal Stent (BMS). Zilver Flex Receives: Device: Treatment with Zilver Flex Bare Metal Stent (BMS) in femoropopliteal lesions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from TLR (Target Lesion Revascularization)
Fraction of study subjects without need for retreatment at treatment location
Measured: 6 months
Freedom from TLR (Target Lesion Revascularization)
Fraction of study subjects without need for retreatment at treatment location
Measured: 12 months
Freedom from TLR (Target Lesion Revascularization)
Fraction of study subjects without need for retreatment at treatment location
Measured: 24 months
Open (functioning and not stenosed) vascular reconstruction (Primary Patency)
Functioning revascularization without adjunctive measures
Measured: 12months
Open (functioning and not stenosed) vascular reconstruction (Primary Patency)
Functioning revascularization without adjunctive measures
Measured: 24 months
Event Free Survival
Alive without vascular events
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start1 Mar 2013
- Primary completion31 Aug 2017
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular DiseasesStudies 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
- Model description
- Randomized trial comparing drug eluting stent Zilver PTX vs Bare metal stent Zilver Flex in critical limb ischemia and treatment of lesions in femoral and popliteal arteries
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Skane University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Torbjorn Fransson, Skane University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05296031
- Sponsor's protocol ID
- TF2
- Status last verified
- Aug 2023
- First submitted
- 7 Mar 2022
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Comparing Drug Eluting Stent Zilver PTX vs Bare Metal Stent Zilver Flex in Critical Limb Ischemia and Treatment of Lesions in Femoral and Popliteal Arteries"
- ClinicalTrials.gov ID
- NCT05296031
- Acronym / sponsor ID
- TF2
- Conditions
- Vascular Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Skane University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2013 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 25 Mar 2022 (actual)
- 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.
Randomized study comparing the results between drug-eluting stents and standard bare metal stents, when treating femoropopliteal lesions in patients with critical limb ischemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized trial comparing drug eluting stent Zilver PTX vs Bare metal stent Zilver Flex in critical limb ischemia and treatment of lesions in femoral and popliteal arteries
| Arm | Type | Receives |
|---|---|---|
| Drug Eluting Stent (DES) | Active comparator | Device: Treatment with Zilver PTX Drug Eluting Stent (DES) in femoropopliteal lesionsDrug Eluting Stent (DES). Zilver PTX. |
| Bare Metal Stent (BMS) | Placebo comparator | Device: Treatment with Zilver Flex Bare Metal Stent (BMS) in femoropopliteal lesionsBare Metal Stent (BMS). Zilver Flex |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Critical limb ischemia RC 4-6
- Lesions in superficial femoral artery and popliteal artery (p1 -p2)
- Target vessel 4-8mm
- At least I 1 vessel runoff to the foot
- Age >18 years
Key exclusion criteria (3 listed)
- Pregnancy
- Patient disapproval
- Age <18 years
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 |
|---|---|---|
| Treatment with Zilver PTX Drug Eluting Stent (DES) in femoropopliteal lesionsRandomized trial comparing drug eluting stent Zilver PTX vs Bare metal stent Zilver Flex in critical limb ischemia and treatment of lesions in femoral and popliteal arteries | Device | Drug Eluting Stent (DES) |
| Treatment with Zilver Flex Bare Metal Stent (BMS) in femoropopliteal lesionsRandomized trial comparing drug eluting stent Zilver PTX vs Bare metal stent Zilver Flex in critical limb ischemia and treatment of lesions in femoral and popliteal arteries | Device | Bare Metal Stent (BMS) |
Primary outcome
Freedom from TLR (Target Lesion Revascularization)
Time frame: 6 months
Fraction of study subjects without need for retreatment at treatment location
Freedom from TLR (Target Lesion Revascularization)
Time frame: 12 months
Fraction of study subjects without need for retreatment at treatment location
Freedom from TLR (Target Lesion Revascularization)
Time frame: 24 months
Fraction of study subjects without need for retreatment at treatment location
Open (functioning and not stenosed) vascular reconstruction (Primary Patency)
Time frame: 12months
Functioning revascularization without adjunctive measures
Open (functioning and not stenosed) vascular reconstruction (Primary Patency)
Time frame: 24 months
Functioning revascularization without adjunctive measures
Event Free Survival
Time frame: 24 months
Alive without vascular events
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 8 Aug 2023.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment with Zilver PTX Drug Eluting Stent (DES) in femoropopliteal lesions and Treatment with Zilver Flex Bare Metal Stent (BMS) in femoropopliteal lesions in people with Vascular Diseases, run by Skane University Hospital.
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 5 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 8 Aug 2023. 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. Some participants in this study may receive a placebo. 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?
Freedom from TLR (Target Lesion Revascularization) (time frame: 6 months). The study lists 6 primary outcomes in all. 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 8 Aug 2023; AzTrials last refreshed its copy on 8 Nov 2026.