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Arterial Occlusive DiseasesEMINENTNCT02921230

Trial Comparing ELUVIA Versus Bare Metal Stent in Treatment of Superficial Femoral and/or Proximal Popliteal Artery

A study testing Peripheral stenting in people with Arterial Occlusive Diseases and Atherosclerosis, run by Boston Scientific Corporation at 60 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The EMINENT study is a prospective, multi-center study evaluating the effectiveness of the ELUVIA stent versus Self-Expanding Bare Nitinol Stents in the treatment of lesions in the femoropopliteal arteries. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Peripheral stenting
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
775 participants
Where
60 sitesin 10 countries
Study dates
25 Oct 2016to 6 Nov 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects age 18 and older
  • Subject is willing and able to provide consent before any study-specific test or procedure is performed, signs the consent form, and agrees to attend all required follow-up visits
  • Chronic, symptomatic lower limb ischemia defined as Rutherford categories 2, 3 or 4
  • Stenotic, restenotic or occlusive lesion(s) located in the native Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA):
  • Degree of stenosis ≥ 70 % by visual angiographic assessment
  • Vessel diameter ≥ 4 and ≤ 6 mm
Show all 10Show fewer
  • Total lesion length (or series of lesions) ≥ 30 mm and ≤210 mm (Note: Lesion segment(s) must be fully covered with one or two overlapping ELUVIA stent(s) or Self Expanding Bare Nitinol stent(s))
  • For occluded lesions (chronic occlusions) requiring use of re-entry device, lesion length ≤ 180 mm
  • Target lesion located at least three centimeters above the inferior edge of the femur
  • Patent infrapopliteal and popliteal artery, i.e., single vessel runoff or better with at least one of three vessels patent (< 50 % stenosis) to the ankle or foot with no planned intervention

Who cannot join

  • Previously stented target lesion/vessel
  • Target lesion/vessel previously treated with drug-coated balloon within 12 months prior to randomization/enrollment
  • Subjects who have undergone prior surgery of the SFA/PPA in the target limb to treat atherosclerotic disease
  • Use of atherectomy, laser or other debulking devices such as Rotarex in the target limb SFA/PPA during the index procedure
  • History of major amputation in the target limb
  • Documented life expectancy less than 24 months due to other medical co-morbid condition(s) that could limit the subject's ability to participate in the clinical study, limit the subject's compliance with the follow-up requirements, or impact the scientific integrity of the clinical study
Show all 22Show fewer
  • Known hypersensitivity or contraindication to contrast dye that, in the opinion of the investigator, cannot be adequately pre-medicated
  • Known hypersensitivity/allergy to the stent system or protocol related therapies (e.g., nitinol, paclitaxel, or structurally related compounds, polymer or individual components, and antiplatelet, anticoagulant, thrombolytic medications)
  • Platelet count less than 80000 mm3 or more than 600000 mm3 or history of bleeding diathesis
  • Concomitant renal failure with a serum creatinine higher than 2.0 mg/dL
  • Receiving dialysis or immunosuppressant therapy
  • History of myocardial infarction (MI) or stroke/cerebrovascular accident (CVA) within 6 months prior to randomization/enrollment
  • Unstable angina pectoris at the time of randomization/enrollment
  • Pregnant, breast feeding, or plan to become pregnant in the next 5 years
  • Current participation in an investigational drug or device clinical study that has not completed the primary endpoint at the time of randomization/ enrollment or that clinically interferes with the current study endpoints (Note: studies requiring extended follow-up for products that were investigational, but have become commercially available since then are not considered investigational studies)
  • Septicemia at the time of randomization/enrollment
  • Presence of other hemodynamically significant outflow lesions in the target limb requiring intervention at the time of the index procedure
  • Presence of aneurysm in the target vessel
  • Acute ischemia and/or acute thrombosis of the SFA/PPA prior to randomization/enrollment
  • Perforated vessel as evidenced by extravasation of contrast media prior to randomization/enrollment
  • Heavily calcified lesions
  • As applicable by French law, subject who is a protected individual such as an incompetent adult or incarcerated person

Trial locations and contacts

60 sites in 10 countries.

60 sites in 10 countries

Germany19 sites

  • Universitäts Herzzentrum

    Bad Krozingen, 79189

  • Sankt Gertrauden-Krankenhaus

    Berlin, 10713

  • Universitätsklinikum Bonn

    Bonn, 53127

  • Universitätsklinikum Essen

    Essen, 45122

  • Krankenhäuser Landkreis Freudenstadt GmbH

    Freudenstadt, 72250

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120

  • SRH Klinikum Karlsbad-Langensteinbach

    Karlsbad, 76307

  • University Hospital Schleswig-Holstein Campus Kiel

    Kiel, 24105

  • University Medical Center of Johannes Gutenberg-Mainz

    Mainz

  • Universitätsklinikum Marburg

    Marburg, 35043

  • Klinik Diakoniewerk München-Maxvorstadt

    München, 80799

  • St. Franziskus-Hospital Muenster

    Münster, 48145

  • Universitätsklinikum Münster

    Münster, 48149

  • Krankenhaus Barmherzige Brüder

    Regensburg, 93049

  • RoMed Klinikum Rosenheim

    Rosenheim, 83022

  • MEDINOS Kliniken Sonneberg GmbH

    Sonneberg

  • Krankenhaus Torgau

    Torgau, 04860

  • University Hospital of Tübingen

    Tübingen, 72076

  • Klinikum Nordoberpfalz AG, Klinikum Weiden

    Weiden

Other trials in Germany

France13 sites

  • Hopital Privé Paul D'Egine

    Champigny-sur-Marne, 94500

  • CHU - Hopital Gabriel Montpied

    Clermont-Ferrand, 63003

  • L'Hôpital Henri-Mondor

    Créteil

  • CHU Dijon

    Dijon, 77908

  • CHU Lille

    Lille, 59037

  • Hopital Edouard Herriot

    Lyon, 69437

  • CHU Nancy

    Nancy, 54500

  • Hopital Nord Laennec

    Nantes, 44093

  • (Hôpital Européen Georges-Pompidou

    Paris, 75015

  • CH de Saint-Nazaire

    Saint-Nazaire, 44606

  • CHU Strasbourg

    Strasbourg, 67091

  • Clinique Pasteur

    Toulouse, 31300

  • CH Valenciennes

    Valenciennes, 59322

Other trials in France

Belgium8 sites

  • OLV Aalst

    Aalst, 9300

  • ZiekenhuisNetwerk Antwerpen

    Antwerp, 2000

  • Imelda Hospital

    Bonheiden, 2820

  • AZ Sint-Blasius

    Dendermonde, 9200

  • UZ Antwerpen

    Edegem, 2650

  • UZ Gent

    Ghent, 9000

  • UZ Leuven

    Leuven, 3000

  • Regionaal Ziekenhuis Heilig Hart Tienen

    Tienen, 3300

Other trials in Belgium

United Kingdom8 sites

  • Royal Bournemouth Hospital

    Bournemouth, BH7 7DW

  • Addenbrookes Hospital

    Cambridge, CB2 0QQ

  • Royal London Hospital

    London, E1 1BB

  • St.Thomas' Hospital

    London, SE1 7EH

  • St. Mary's Hospital

    London, W2 1NY

  • Manchester University NHS Foundation Trust

    Manchester, M13 9WL

  • Freeman Hospital

    Newcastle upon Tyne, NE7 7DN

  • Nottingham University Hospital

    Nottingham, NG7 2UH

Other trials in United Kingdom

Austria3 sites

  • LKH Innsbruck

    Innsbruck, 6020

  • Klinikum Klagenfurt

    Klagenfurt, 9020

  • Allgemeines Krankenhaus Wien

    Vienna, 1090

Other trials in Austria

Italy3 sites

  • San Raffaele Hospital

    Milan, 20132

  • Centro cardiologico Monzino

    Milan, 20138

  • Ospedaliero Universitaria Federico II

    Naples

Other trials in Italy

Netherlands2 sites

  • Hagaziekenhuis

    The Hague, 2545

  • Elisabeth Tilburg Ziekenhuis

    Tilburg, 5022 GC

Other trials in Netherlands

Switzerland2 sites

  • Inselspital Bern

    Bern, 3010

  • Kantonsspital Luzern

    Lucerne, 6000

Other trials in Switzerland

Ireland1 site

  • Beaumont Hospital

    Dublin

Other trials in Ireland

Spain1 site

  • Hospital Virgen Macarena

    Seville, 41007

Other trials in Spain

About this study

Official title: A Randomized Trial Comparing the ELUVIA Drug-eluting Stent Versus Bare Metal Self-expanding Nitinol Stents in the Treatment of Superficial Femoral and/or Proximal Popliteal Arteries

The EMINENT study is a prospective, multi-center study evaluating the effectiveness of the ELUVIA stent versus Self-Expanding Bare Nitinol Stents in the treatment of lesions in the femoropopliteal arteries.

Read the detailed description

The EMINENT study is a prospective, multi-center study evaluating the effectiveness of the ELUVIA stent versus Self-Expanding Bare Nitinol Stents in the treatment of lesions 30-210 mm long located in the femoropopliteal arteries in subjects with symptoms classified as Rutherford categories 2-4.

The study is a 2:1 randomized (ELUVIA vs Self-Expanding Bare Nitinol Stents), controlled, single-blind, superiority trial (RCT).

The objective of the study is to evaluate the effectiveness of the ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions up to 210 mm in length when compared against bare metal stents, and collect additional data including health economics data.

Being tested
Peripheral stenting
Keywords
atherosclerosis, Superficial Femoral Artery (SFA), Proximal Popliteal Artery (PPA), stenting, paclitaxel
Medical subject headings
Arterial Occlusive Diseases, Atherosclerosis, Vascular Diseases, Arteriosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Peripheral stentingDevice

    stent implantation during the index procedure

Study groups in NCT02921230
Study groupRoleWhat they receive
ELUVIA Stent ImplantationExperimentalPeripheral stenting
Receives: Device: Peripheral stenting
control Bare Metal Stent ImplantationActive comparatorPeripheral stenting
Receives: Device: Peripheral stenting

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Subjects With Primary Patency at 12 Months Post-procedure

    The primary effectiveness endpoint assesses primary patency at 12 months post-procedure. This effectiveness endpoint is designed to demonstrate that the 12-month primary patency for the ELUVIA treatment group is superior to the Self-Expanding Bare Nitinol Stents treatment group.

    Measured: 12 Months

Secondary outcomes (5)

  1. Number of Subjects Walking Improvement - Distance at Baseline to 12 Months

    Walking Improvement will be assessed and compared between the 2 study arms, by evaluating the change in Six Minute Hall Walk (6MHW) / treadmill test from baseline, or preceding any Target Vessel Revascularization and evaluating change in Walking Impairment Questionnaire (WIQ) from baseline.

    Values are represented as a mean and standard deviation and reflect the change in meters walked.

    Measured: 12 Months

  2. Number of Subjects Change in Quality of Life - Improvement From Baseline to 12 Month

    The change in quality of life will be assessed and compared between the 2 study arms, by evaluating change in EuroQol (EQ) - 5 Dimensions (5D) - 5 Levels (5L) questionnaire (EQ-5D-5L™) from baseline, or preceding any Target Vessel Revascularization Values are presented as a count of subjects at 12-months and by the number of subjects analyzed.

    Measured: 12 Months

  3. Cost Effectiveness

    Cost effectiveness of ELUVIA™ drug-eluting stent versus bare metal self-expanding nitinol stents.

    Measured: during index procedure, 1, 6, 12, 24 and 36 months

  4. Number of Subjects With Clinical Improvement at 12-months

    Clinical improvement will be evaluated by assessing the changes in Rutherford Classification from baseline.

    Values are presented as a count of participants at 12-months by the number of participants analyzed.

    Rutherford Classification describes 7 categories of peripheral artery disease, including both the patient's clinical symptoms as well as objective findings;

    Primary sustained clinical improvement, is a rate of improvement in Rutherford classification of one or more categories as compared to baseline without the need for repeat target lesion revascularization (TLR);

    Secondary sustained clinical improvement is a rate of improvement in Rutherford classification of one or more categories as compared to baseline including those subjects with repeat TLR;

    Clinical deterioration, is the rate of downgrade in Rutherford classification of one or more categories as compared to baseline

    Measured: 12 months

  5. Number of Subjects With Hemodynamic Improvement at 12-months

    Hemodynamic improvement was evaluated by assessing the number of participants that demonstrated an increase in the Ankle-Brachial Index value of >/= 0.10 or an increase in the overall ABI value to >/= 0.90 from baseline to 12 months

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2016 (estimated)
  2. Study start25 Oct 2016
  3. Primary completion2 Jul 2021
  4. Study completion6 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
775 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02921230
Sponsor's protocol ID
S2366
Acronym
EMINENT
Status last verified
Feb 2025
First submitted
6 Sep 2016
Last updated
24 Feb 2025
Data monitoring committee
No
Individual data sharing
No

Publications

  • Goueffic Y, Torsello G, Zeller T, Esposito G, Vermassen F, Hausegger KA, Tepe G, Thieme M, Gschwandtner M, Kahlberg A, Schindewolf M, Sapoval M, Diaz-Cartelle J, Stavroulakis K; EMINENT Investigators. Efficacy of a Drug-Eluting Stent Versus Bare Metal Stents for Symptomatic Femoropopliteal Peripheral Artery Disease: Primary Results of the EMINENT Randomized Trial. Circulation. 2022 Nov 22;146(21):1564-1576. doi: 10.1161/CIRCULATIONAHA.122.059606. Epub 2022 Oct 18.

    PubMed 36254728

Questions about this trial

What is this clinical trial studying?

A study testing Peripheral stenting in people with Arterial Occlusive Diseases and Atherosclerosis, run by Boston Scientific Corporation at 60 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in Germany, France, Belgium, United Kingdom, Austria and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects With Primary Patency at 12 Months Post-procedure (time frame: 12 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02921230, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.

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