Peripheral Arterial DiseaseNCT03941314
A Superiority Trial of the SUPERA Peripheral Stent System in Patients With Femoro-popliteal Artery Disease
A study testing Supera® Peripheral Stent System and EverFlex™ Self-Expanding Peripheral Stent System in people with Peripheral Arterial Disease, run by Kantonsspital Winterthur KSW at 3 sites in 2 countries.
Trial summary
The purpose of this study (superiority trial) is to compare the Supera® Peripheral Stent System with a standard nitinol self-expanding stent for treatment of femoro-popliteal arterial occlusive disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Supera® Peripheral Stent System and EverFlex™ Self-Expanding Peripheral Stent System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 25 Jun 2019to 19 Mar 2026
- 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 with femoro-popliteal artery disease, who will require a stent femoro-popliteal following failed percutaneous transluminal angioplasty (PTA)
- Target Lesion length <200mm
- Planned follow-up available for at least 24 months
- Written informed consent to participate in the study and agreement to comply with the study protocol must be obtained from the patient prior to initiation of any study-mandated procedure and randomization
Who cannot join
- Life expectancy <24 months
- Patients who cannot receive dual antiplatelet therapy (aspirin 100mg and clopidogrel 75mg) or anticoagulation therapy
- Patients with known allergies to: nitinol (nickel titanium); or contrast agent, that cannot be medically managed
- Participation in another study with investigational drug/device within the 30 days preceding and during the present study
- Previous enrolment into the current study
- Prior stenting at the location of intended stenting
Show all 9Show fewer
- Patients who are judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or stent delivery system
- Enrolment of study investigator, his/her family members, employees and other dependent persons
- If female and of childbearing potential: known pregnancy or a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Switzerland2 sites
Kantonsspital St. Gallen
Sankt Gallen, CH-9007
Kantonsspital Winterthur
Winterthur, CH-8401
About this study
Official title: A Prospective Randomized, Parallel-group, Multicentre, Superiority Trial of the SUPERA Peripheral Stent System in Patients With Femoro-popliteal Artery Disease
The purpose of this study (superiority trial) is to compare the Supera® Peripheral Stent System with a standard nitinol self-expanding stent for treatment of femoro-popliteal arterial occlusive disease.
Hypothesis:
The Supera® stent is superior to a standard nitinol self-expanding stent, for treatment of femoro-popliteal artery disease in terms of (1) primary patency rate and (2) need for revascularization up to 24 months after stent insertion.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Supera® Peripheral Stent System, EverFlex™ Self-Expanding Peripheral Stent System
- 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.
Supera® Peripheral Stent SystemDevice
The index procedure is placing a selfexpandable stent at a femoro-popliteal location. The way the stenosis or occlusion is traversed is not part of the study. It is mandatory to prepare then the vessel with PTA (at least the size of the stent) and thereafter insert the stent. Post-PTA can be performed with same balloon, but post-PTA is not mandatory to be performed.
EverFlex™ Self-Expanding Peripheral Stent SystemDevice
Also called EverFlex™ with Entrust™ Delivery System or Protégé™ EverFlex™
The index procedure is placing a selfexpandable stent at a femoro-popliteal location. The way the stenosis or occlusion is traversed is not part of the study. It is mandatory to prepare then the vessel with PTA (at least the size of the stent) and thereafter insert the stent. Post-PTA can be performed with same balloon, but post-PTA is not mandatory to be performed.
| Study group | Role | What they receive |
|---|---|---|
| Supera® Peripheral Stent System | Experimental | Femoro-popliteal arterial stenting with Supera® Peripheral Stent System as CE-marked by the manufacturer Abbott Receives: Device: Supera® Peripheral Stent System |
| EverFlex™ Self-Expanding Peripheral Stent System | Active comparator | Femoro-popliteal arterial stenting with EverFlex™ Self-Expanding Peripheral Stent System with Entrust™ Delivery System or as Protégé™ EverFlex™ Receives: Device: EverFlex™ Self-Expanding Peripheral Stent System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in primary patency rate (proportion of patients classed as treatment succsess)
Peak systolic velocity ratio assessed with Duplex ultrasound (Treatment success is defined as Peak Systolic Velocity (PSV) ratio < 2.5 at the stented target lesion measured by Duplex ultrasound (DUS) indicating freedom from >50% restenosis with no clinically driven re-intervention within the stented segment.)
Measured: 24 months
Secondary outcomes (6)
Difference in primary patency rate
Peak systolic velocity ratio assessed with Duplex ultrasound
Measured: 1 month, 6 months, 12 months
Difference in target lesion/vessel revascularization
Patients with target lesion revascularization due to restenosis or target vessel revascularization.
Measured: 24 months
Difference in amputation
Proportion of patients with amputation (minor or major)
Measured: 24 months
Difference in time to restenosis (and time to target lesion revascularization due to restenosis)
Measured: 24 months
Difference in Anklre Brachial Index
Ankle Brachial Index of the treated lesion
Measured: 1 month, 6 months, 12 months, 24 months
Difference in Fontaine classification
Fontaine classification
Measured: 1 month, 6 months, 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start25 Jun 2019
- Primary completion19 Mar 2026
- Study completion19 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Winterthur KSW
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott, Cantonal Hospital of St. Gallen
- Responsible party
- Sponsor
- Investigators
- Christoph A Binkert, MD, Principal investigator, Kantonsspital Winterthur KSW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03941314
- Sponsor's protocol ID
- BASEC 2019-00312
- Other IDs
- CTU 17/037
- Status last verified
- Jun 2026
- First submitted
- 2 May 2019
- Last updated
- 12 Jun 2026
- 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 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized, Parallel-group, Multicentre, Superiority Trial of the SUPERA Peripheral Stent System in Patients With Femoro-popliteal Artery Disease
- ClinicalTrials.gov ID
- NCT03941314
- Acronym / sponsor ID
- BASEC 2019-00312
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Kantonsspital Winterthur KSWUniversity, hospital or other
- Collaborators
- Abbott, Cantonal Hospital of St. Gallen
- Study start
- 25 Jun 2019 (actual)
- Primary completion
- 19 Mar 2026 (actual)
- Study completion
- 19 Mar 2026 (actual)
- First posted
- 7 May 2019 (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.
The purpose of this study (superiority trial) is to compare the Supera® Peripheral Stent System with a standard nitinol self-expanding stent for treatment of femoro-popliteal arterial occlusive disease.
Hypothesis:
The Supera® stent is superior to a standard nitinol self-expanding stent, for treatment of femoro-popliteal artery disease in terms of (1) primary patency rate and (2) need for revascularization up to 24 months after stent insertion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supera® Peripheral Stent System | Experimental | Device: Supera® Peripheral Stent SystemFemoro-popliteal arterial stenting with Supera® Peripheral Stent System as CE-marked by the manufacturer Abbott |
| EverFlex™ Self-Expanding Peripheral Stent System | Active comparator | Device: EverFlex™ Self-Expanding Peripheral Stent SystemFemoro-popliteal arterial stenting with EverFlex™ Self-Expanding Peripheral Stent System with Entrust™ Delivery System or as Protégé™ EverFlex™ |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with femoro-popliteal artery disease, who will require a stent femoro-popliteal following failed percutaneous transluminal angioplasty (PTA)
- Target Lesion length <200mm
- Planned follow-up available for at least 24 months
- Written informed consent to participate in the study and agreement to comply with the study protocol must be obtained from the patient prior to initiation of any study-mandated procedure and randomization
Key exclusion criteria (9 listed)
- Life expectancy <24 months
- Patients who cannot receive dual antiplatelet therapy (aspirin 100mg and clopidogrel 75mg) or anticoagulation therapy
- Patients with known allergies to: nitinol (nickel titanium); or contrast agent, that cannot be medically managed
- Participation in another study with investigational drug/device within the 30 days preceding and during the present study
- Previous enrolment into the current study
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 |
|---|---|---|
| Supera® Peripheral Stent SystemThe index procedure is placing a selfexpandable stent at a femoro-popliteal location. The way the stenosis or occlusion is traversed is not part of the study. It is mandatory to prepare then the vessel with PTA (at least the size of the stent) and thereafter insert the stent. Post-PTA can be performed with same balloon, but post-PTA is not mandatory to be performed. | Device | Supera® Peripheral Stent System |
| EverFlex™ Self-Expanding Peripheral Stent SystemAlso: EverFlex™ with Entrust™ Delivery System or Protégé™ EverFlex™The index procedure is placing a selfexpandable stent at a femoro-popliteal location. The way the stenosis or occlusion is traversed is not part of the study. It is mandatory to prepare then the vessel with PTA (at least the size of the stent) and thereafter insert the stent. Post-PTA can be performed with same balloon, but post-PTA is not mandatory to be performed. | Device | EverFlex™ Self-Expanding Peripheral Stent System |
Primary outcome
Difference in primary patency rate (proportion of patients classed as treatment succsess)
Time frame: 24 months
Peak systolic velocity ratio assessed with Duplex ultrasound (Treatment success is defined as Peak Systolic Velocity (PSV) ratio < 2.5 at the stented target lesion measured by Duplex ultrasound (DUS) indicating freedom from >50% restenosis with no clinically driven re-intervention within the stented segment.)
6 secondary outcomes
Difference in primary patency rate
Time frame: 1 month, 6 months, 12 months
Difference in target lesion/vessel revascularization
Time frame: 24 months
Difference in amputation
Time frame: 24 months
Difference in time to restenosis (and time to target lesion revascularization due to restenosis)
Time frame: 24 months
Difference in Anklre Brachial Index
Time frame: 1 month, 6 months, 12 months, 24 months
Difference in Fontaine classification
Time frame: 1 month, 6 months, 12 months, 24 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 12 Jun 2026.
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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.
Christoph A Binkert, MD principal investigator
Kantonsspital Winterthur KSW
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supera® Peripheral Stent System and EverFlex™ Self-Expanding Peripheral Stent System in people with Peripheral Arterial Disease, run by Kantonsspital Winterthur KSW at 3 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 4 inclusion and 9 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 Jun 2026. 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 Switzerland, Spain. 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?
Difference in primary patency rate (proportion of patients classed as treatment succsess) (time frame: 24 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 12 Jun 2026.