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

NCT02921230 | Completed Results

• 1 other identifier: S2366
• Study Type: interventional
• Target: 775
• Locations: 10 countries
• Sites: 60

Brief 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.

Conditions

Arterial Occlusive Diseases; Atherosclerosis; Vascular Diseases; Arteriosclerosis

Keywords

atherosclerosis; Superficial Femoral Artery (SFA); Proximal Popliteal Artery (PPA); stenting; paclitaxel

Outcome Measures

Primary Outcomes (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.

  12 Months

Secondary Outcomes (5)

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

  12 Months

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

  12 Months

• Cost Effectiveness

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

• Number of Subjects With Clinical Improvement at 12-months

  12 months

• Number of Subjects With Hemodynamic Improvement at 12-months

  12 months

Other Outcomes (11)

• Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months

  1, 6, 12, 24, and 36 months

• Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months

  1, 6, 24, and 36 months

• Number of Subjects With Clinical Improvement at 1-month, 6-months, 24-months, and 36-months

  1, 6, 24, and 36 months

Study Arms (2)

ELUVIA Stent Implantation

EXPERIMENTAL

Peripheral stenting

Device: Peripheral stenting

control Bare Metal Stent Implantation

ACTIVE COMPARATOR

Peripheral stenting

Device: Peripheral stenting

Interventions

Peripheral stenting DEVICE

stent implantation during the index procedure

ELUVIA Stent Implantation; control Bare Metal Stent Implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (60)

LKH Innsbruck

Innsbruck, 6020, Austria

Location

Klinikum Klagenfurt

Klagenfurt, 9020, Austria

Location

Allgemeines Krankenhaus Wien

Vienna, 1090, Austria

Location

OLV Aalst

Aalst, 9300, Belgium

Location

ZiekenhuisNetwerk Antwerpen

Antwerp, 2000, Belgium

Location

Imelda Hospital

Bonheiden, 2820, Belgium

Location

AZ Sint-Blasius

Dendermonde, 9200, Belgium

Location

UZ Antwerpen

Edegem, 2650, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Regionaal Ziekenhuis Heilig Hart Tienen

Tienen, 3300, Belgium

Location

Hopital Privé Paul D'Egine

Champigny-sur-Marne, 94500, France

Location

CHU - Hopital Gabriel Montpied

Clermont-Ferrand, 63003, France

Location

L'Hôpital Henri-Mondor

Créteil, France

Location

CHU Dijon

Dijon, 77908, France

Location

CHU Lille

Lille, 59037, France

Location

Hopital Edouard Herriot

Lyon, 69437, France

Location

CHU Nancy

Nancy, 54500, France

Location

Hopital Nord Laennec

Nantes, 44093, France

Location

(Hôpital Européen Georges-Pompidou

Paris, 75015, France

Location

CH de Saint-Nazaire

Saint-Nazaire, 44606, France

Location

CHU Strasbourg

Strasbourg, 67091, France

Location

Clinique Pasteur

Toulouse, 31300, France

Location

CH Valenciennes

Valenciennes, 59322, France

Location

Universitäts Herzzentrum

Bad Krozingen, 79189, Germany

Location

Sankt Gertrauden-Krankenhaus

Berlin, 10713, Germany

Location

Universitätsklinikum Bonn

Bonn, 53127, Germany

Location

Universitätsklinikum Essen

Essen, 45122, Germany

Location

Krankenhäuser Landkreis Freudenstadt GmbH

Freudenstadt, 72250, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

SRH Klinikum Karlsbad-Langensteinbach

Karlsbad, 76307, Germany

Location

University Hospital Schleswig-Holstein Campus Kiel

Kiel, 24105, Germany

Location

University Medical Center of Johannes Gutenberg-Mainz

Mainz, Germany

Location

Universitätsklinikum Marburg

Marburg, 35043, Germany

Location

Klinik Diakoniewerk München-Maxvorstadt

München, 80799, Germany

Location

St. Franziskus-Hospital Muenster

Münster, 48145, Germany

Location

Universitätsklinikum Münster

Münster, 48149, Germany

Location

Krankenhaus Barmherzige Brüder

Regensburg, 93049, Germany

Location

RoMed Klinikum Rosenheim

Rosenheim, 83022, Germany

Location

MEDINOS Kliniken Sonneberg GmbH

Sonneberg, Germany

Location

Krankenhaus Torgau

Torgau, 04860, Germany

Location

University Hospital of Tübingen

Tübingen, 72076, Germany

Location

Klinikum Nordoberpfalz AG, Klinikum Weiden

Weiden, Germany

Location

Beaumont Hospital

Dublin, Ireland

Location

San Raffaele Hospital

Milan, 20132, Italy

Location

Centro cardiologico Monzino

Milan, 20138, Italy

Location

Ospedaliero Universitaria Federico II

Naples, Italy

Location

Hagaziekenhuis

The Hague, 2545, Netherlands

Location

Elisabeth Tilburg Ziekenhuis

Tilburg, 5022 GC, Netherlands

Location

Hospital Virgen Macarena

Seville, 41007, Spain

Location

Inselspital Bern

Bern, 3010, Switzerland

Location

Kantonsspital Luzern

Lucerne, 6000, Switzerland

Location

Royal Bournemouth Hospital

Bournemouth, BH7 7DW, United Kingdom

Location

Addenbrookes Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

Royal London Hospital

London, E1 1BB, United Kingdom

Location

St.Thomas' Hospital

London, SE1 7EH, United Kingdom

Location

St. Mary's Hospital

London, W2 1NY, United Kingdom

Location

Manchester University NHS Foundation Trust

Manchester, M13 9WL, United Kingdom

Location

Freeman Hospital

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Nottingham University Hospital

Nottingham, NG7 2UH, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 36254728 DERIVED

MeSH Terms

Conditions

Arterial Occlusive Diseases; Atherosclerosis; Vascular Diseases; Arteriosclerosis

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Limitations and Caveats

COVID-19 pandemic impacted the amount of imaging data collected causing insufficiencies to calculate rates to appropriately report some outcome measures particularly with data at 24 and 36 months follow up visits.

Results Point of Contact

• Title: Andrew Campbell
• Organization: Boston Scientific

Andrew.Campbell@bsci.com

763-494-2722

Study Officials

• Giovanni Torsello, MD

  Sint-Franziskus-Hospital GmbH

  PRINCIPAL INVESTIGATOR

• Yann Goueffic

  Hôpital St Joseph Paris

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2016
• First Posted: October 3, 2016
• Study Start: October 25, 2016
• Primary Completion: July 2, 2021
• Study Completion: November 6, 2023
• Last Updated: February 24, 2025
• Results First Posted: October 28, 2024

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (19); IT (3); NL (2); ES (1); GB (8); BE (8); IE (1); CH (2); FR (13); AU (3)