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New stent aims to keep leg arteries open longer

NCT ID NCT03941314

Disease control Sponsor: Kantonsspital Winterthur KSW Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a newer stent (Supera) works better than a standard stent for people with blocked arteries in the leg. About 300 patients received one of the two stents. The goal was to see which stent kept the artery open longer and reduced the need for another procedure over two years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Supera® Peripheral Stent System (a flexible metal tube placed in the leg artery to keep it open)
What this could lead to
If it works, this could show that the Supera stent is better at keeping leg arteries open and reducing the need for repeat procedures.
What could go wrong
This is a completed trial, but results may not apply to all patients. Stents can still fail or cause complications like re-blockage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

300 people

The number who actually took part.

Started

Jun 2019

Finished

Mar 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

peripheral arterial disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Peripheral arterial disease

Contacts and locations

Locations

  • Hospital Carlos Haya

    Málaga, 29010, Spain

  • Kantonsspital St. Gallen

    Sankt Gallen, CH-9007, Switzerland

  • Kantonsspital Winterthur

    Winterthur, CH-8401, Switzerland

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