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NCT Number: NCT03941314

A 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.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Carlos Haya, Málaga, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Supera® Peripheral Stent System

Device

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 System

Device

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.

Other names: EverFlex™ with Entrust™ Delivery System or Protégé™ EverFlex™

Primary outcomes

  1. 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.)

Secondary outcomes

  1. Difference in primary patency rate

    Time frame: 1 month, 6 months, 12 months

    Peak systolic velocity ratio assessed with Duplex ultrasound

  2. Difference in target lesion/vessel revascularization

    Time frame: 24 months

    Patients with target lesion revascularization due to restenosis or target vessel revascularization.

  3. Difference in amputation

    Time frame: 24 months

    Proportion of patients with amputation (minor or major)

  4. Difference in time to restenosis (and time to target lesion revascularization due to restenosis)

    Time frame: 24 months

  5. Difference in Anklre Brachial Index

    Time frame: 1 month, 6 months, 12 months, 24 months

    Ankle Brachial Index of the treated lesion

  6. Difference in Fontaine classification

    Time frame: 1 month, 6 months, 12 months, 24 months

    Fontaine classification

Other outcomes

  1. Rate of site complications [Safety Endpoint]

    Time frame: 1 month

  2. Rate of prolonged hospital stay [Safety Endpoint]

    Time frame: 1 month

  3. Rate of need for surgical revision [Safety Endpoint]

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Kantonsspital Winterthur KSW

Other

Collaborators

  • Abbott
  • Cantonal Hospital of St. Gallen

Registry information

Official study title

A Prospective Randomized, Parallel-group, Multicentre, Superiority Trial of the SUPERA Peripheral Stent System in Patients With Femoro-popliteal Artery Disease

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
May 7, 2019
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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