A Superiority Trial of the SUPERA Peripheral Stent System in Patients With Femoro-popliteal Artery Disease
Key facts
- Who runs it
- Kantonsspital Winterthur KSW
- Where
- Spain and Switzerland3 sites in 2 countriesChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 300 people enrolled
- Started
- 25 Jun 2019
- Ended
- 19 Mar 2026
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Supera® Peripheral Stent System
- EverFlex™ Self-Expanding Peripheral Stent System
- Record updated
- 12 June 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- 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 take part
- Patients who cannot receive dual antiplatelet therapy (aspirin 100mg and clopidogrel 75mg) or anticoagulation therapy
- 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
- Patients with known allergies to: nitinol (nickel titanium); or contrast agent, that cannot be medically managed
- If female and of childbearing potential: known pregnancy or a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating
- Life expectancy <24 months
- 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
This trial has no sites in United States.
It has sites in 2 countries. Choose a country to see its sites.
About the trial
What the trial wants to find out
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 full original descriptionShow less
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.
The 2 groups in the trial
- Supera® Peripheral Stent SystemTreatment being tested
Femoro-popliteal arterial stenting with Supera® Peripheral Stent System as CE-marked by the manufacturer Abbott
- EverFlex™ Self-Expanding Peripheral Stent SystemExisting treatment, for comparison
Femoro-popliteal arterial stenting with EverFlex™ Self-Expanding Peripheral Stent System with Entrust™ Delivery System or as Protégé™ EverFlex™
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Prospective Randomized, Parallel-group, Multicentre, Superiority Trial of the SUPERA Peripheral Stent System in Patients With Femoro-popliteal Artery Disease
- Record updated
- 12 June 2026