A Superiority Trial of the SUPERA Peripheral Stent System in Patients With Femoro-popliteal Artery Disease

  • STATUS
    Recruiting
  • End date
    May 26, 2023
  • participants needed
    300
  • sponsor
    Kantonsspital Winterthur KSW
Updated on 11 February 2022
arterial occlusive disease
arteriopathy
stenosis
transluminal angioplasty
everflex
revascularisation

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.

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.

Details
Condition Peripheral Arterial Disease
Treatment Supera® Peripheral Stent System, EverFlex™ Self-Expanding Peripheral Stent System
Clinical Study IdentifierNCT03941314
SponsorKantonsspital Winterthur KSW
Last Modified on11 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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