Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New stent helps people with leg artery disease walk better and feel better

NCT ID NCT03037411

Disease control Sponsor: Boston Scientific Corporation 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looked at how well the ELUVIA drug-coated stent works in real-world patients with blocked arteries in the thigh or knee area. A total of 291 adults received the stent and were followed for two years. The main goal was to see if their quality of life and walking ability improved.

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.

Participants

291 people

The number who actually took part.

Started

Dec 2016

Finished

Mar 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

The Intended population for the REGAL study are 'real world'-patients with symptomatic de-novo, restenotic, or (re)occluded lesions in the native superficial femoral artery (SFA) and/or proximal popliteal artery with reference vessel diameter (RVD) ranging from 4.0-6.0 mm, suitable for endovascular treatment.

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: 1. Subjects age 18 and older 2. Subject is willing and able to provide written consent before any study-specific test or procedure is performed and agrees to attend all follow-up visits 3. De novo, restenotic or (re)occluded lesions in the native femoro-popliteal arteries, with reference vessel diameter (RVD) ranging from 4.0-6.0 mm, suitable for endovascular treatment Exclusion Criteria: 1. Subject is pregnant or planning to become pregnant during the course of the study 2. Life expectancy of less than 1 year (which is defined as documented life expectancy less than 12 months due to other medical co-morbid condition(s) that could limit the subject's ability to participate in the clinical follow-up, limit the subject's compliance with the standard of care follow-up, or impact the scientific integrity of the trial) 3. Known allergy to the ELUVIA stent system or any of its components, concomitant medication, contrast agents (that cannot be medically managed) 4. Subject enrolled in an investigational study that has not reached primary endpoint at the time of enrollment or that clinically interferes with the current study assessments (Note: studies requiring extended follow-up for products that were investigational, but have become commercially available since then are not considered investigational studies)

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Arterial occlusive diseases are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Arterial Occlusive Diseases arteriosclerosis disorder atherosclerosis peripheral arterial disease vascular disorder

As listed by the trial registrant

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

Arterial occlusive diseases Arteriosclerosis Atherosclerosis Vascular diseases

Contacts and locations

Locations

  • ASL Asti

    Asti, 14100, Italy

  • CHU Sart Tilman

    Liège, Belgium

  • Centre Hospitalier Universitaire Grenoble-Alpes

    Grenoble, France

  • Clinique Parly II

    Le Chesnay, 78150, France

  • Foundation for the Aragonese Healthcare Research Institute

    Zaragoza, 50009, Spain

  • Hosp . Universitario de Guadalajara

    Guadalajara, 19002, Spain

  • Hosp. Complejo Hosp Universitario (CHUO)

    Ourense, Spain

  • Hosp. Ntra Sra. del Rosario

    Madrid, 28006, Spain

  • Hosp. Puerta del Mar

    Cadiz, Spain

  • Hospital Azienda Ospedaliera Universitaria Senese

    Siena, 53100, Italy

  • Hospital Clinico San Carlos

    Madrid, 28040, Spain

  • Hospital Parc Tauli

    Sabadell, Spain

  • Hospital San Pedro de Alcántara

    Cáceres, 10004, Spain

  • Hospital Universitario de Burgos

    Burgos, 09006, Spain

  • Hospital de Montecelo (Pontevedra EOXI)

    Pontevedra, 30071, Spain

  • IRCCS Policlinico San Donato

    San Donato Milanese, Italy

  • L'Azienda sanitaira ASL Roma 1

    Roma, 00193, Italy

  • Medizinische Universität Graz

    Graz, Austria

  • Policlinico Umberto I

    Roma, 00161, Italy

  • Policlinico Vittorio Emanuele

    Catania, Italy

  • Policlinico di Monza

    Monza, Italy

  • Regionaal Ziekenhuis Heilig Hart Tienen

    Tienen, Vlaams-Brabant, 3300, Belgium

  • ZOL Genk

    Genk, Limburg, 3600, Belgium

More trials for these conditions

Other studies related to the condition(s) this trial covers.