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

NCT ID: NCT02921230

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 775 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-25
• Study Completion Date: 2023-11-06

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.

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.

Conditions

Arterial Occlusive Diseases; Atherosclerosis; Vascular Diseases; Arteriosclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ELUVIA Stent Implantation

Peripheral stenting

Group Type: EXPERIMENTAL

Peripheral stenting

Intervention Type: DEVICE

stent implantation during the index procedure

control Bare Metal Stent Implantation

Peripheral stenting

Group Type: ACTIVE_COMPARATOR

Peripheral stenting

Intervention Type: DEVICE

stent implantation during the index procedure

Interventions

Peripheral stenting

stent implantation during the index procedure

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Subjects age 18 and older

2. 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

3. Chronic, symptomatic lower limb ischemia defined as Rutherford categories 2, 3 or 4

4. Stenotic, restenotic or occlusive lesion(s) located in the native Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA):

1. Degree of stenosis ≥ 70 % by visual angiographic assessment

2. Vessel diameter ≥ 4 and ≤ 6 mm

3. 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))

4. For occluded lesions (chronic occlusions) requiring use of re-entry device, lesion length ≤ 180 mm

5. Target lesion located at least three centimeters above the inferior edge of the femur

5. 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

Exclusion Criteria

1. Previously stented target lesion/vessel

2. Target lesion/vessel previously treated with drug-coated balloon within 12 months prior to randomization/enrollment

3. Subjects who have undergone prior surgery of the SFA/PPA in the target limb to treat atherosclerotic disease

4. Use of atherectomy, laser or other debulking devices such as Rotarex in the target limb SFA/PPA during the index procedure

5. History of major amputation in the target limb

6. 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

7. Known hypersensitivity or contraindication to contrast dye that, in the opinion of the investigator, cannot be adequately pre-medicated

8. 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)

9. Platelet count less than 80000 mm3 or more than 600000 mm3 or history of bleeding diathesis

10. Concomitant renal failure with a serum creatinine higher than 2.0 mg/dL

11. Receiving dialysis or immunosuppressant therapy

12. History of myocardial infarction (MI) or stroke/cerebrovascular accident (CVA) within 6 months prior to randomization/enrollment

13. Unstable angina pectoris at the time of randomization/enrollment

14. Pregnant, breast feeding, or plan to become pregnant in the next 5 years

15. 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)

16. Septicemia at the time of randomization/enrollment

17. Presence of other hemodynamically significant outflow lesions in the target limb requiring intervention at the time of the index procedure

18. Presence of aneurysm in the target vessel

19. Acute ischemia and/or acute thrombosis of the SFA/PPA prior to randomization/enrollment

20. Perforated vessel as evidenced by extravasation of contrast media prior to randomization/enrollment

21. Heavily calcified lesions

22. As applicable by French law, subject who is a protected individual such as an incompetent adult or incarcerated person

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giovanni Torsello, MD

Role: PRINCIPAL_INVESTIGATOR

Sint-Franziskus-Hospital GmbH

Yann Goueffic

Role: PRINCIPAL_INVESTIGATOR

Hôpital St Joseph Paris

Locations

LKH Innsbruck

Innsbruck, , Austria

Klinikum Klagenfurt

Klagenfurt, , Austria

Allgemeines Krankenhaus Wien

Vienna, , Austria

OLV Aalst

Aalst, , Belgium

ZiekenhuisNetwerk Antwerpen

Antwerp, , Belgium

Imelda Hospital

Bonheiden, , Belgium

AZ Sint-Blasius

Dendermonde, , Belgium

UZ Antwerpen

Edegem, , Belgium

UZ Gent

Ghent, , Belgium

UZ Leuven

Leuven, , Belgium

Regionaal Ziekenhuis Heilig Hart Tienen

Tienen, , Belgium

Hopital Privé Paul D'Egine

Champigny-sur-Marne, , France

CHU - Hopital Gabriel Montpied

Clermont-Ferrand, , France

L'Hôpital Henri-Mondor

Créteil, , France

CHU Dijon

Dijon, , France

CHU Lille

Lille, , France

Hopital Edouard Herriot

Lyon, , France

CHU Nancy

Nancy, , France

Hopital Nord Laennec

Nantes, , France

(Hôpital Européen Georges-Pompidou

Paris, , France

CH de Saint-Nazaire

Saint-Nazaire, , France

CHU Strasbourg

Strasbourg, , France

Clinique Pasteur

Toulouse, , France

CH Valenciennes

Valenciennes, , France

Universitäts Herzzentrum

Bad Krozingen, , Germany

Sankt Gertrauden-Krankenhaus

Berlin, , Germany

Universitätsklinikum Bonn

Bonn, , Germany

Universitätsklinikum Essen

Essen, , Germany

Krankenhäuser Landkreis Freudenstadt GmbH

Freudenstadt, , Germany

Universitätsklinikum Heidelberg

Heidelberg, , Germany

SRH Klinikum Karlsbad-Langensteinbach

Karlsbad, , Germany

University Hospital Schleswig-Holstein Campus Kiel

Kiel, , Germany

University Medical Center of Johannes Gutenberg-Mainz

Mainz, , Germany

Universitätsklinikum Marburg

Marburg, , Germany

Klinik Diakoniewerk München-Maxvorstadt

München, , Germany

St. Franziskus-Hospital Muenster

Münster, , Germany

Universitätsklinikum Münster

Münster, , Germany

Krankenhaus Barmherzige Brüder

Regensburg, , Germany

RoMed Klinikum Rosenheim

Rosenheim, , Germany

MEDINOS Kliniken Sonneberg GmbH

Sonneberg, , Germany

Krankenhaus Torgau

Torgau, , Germany

University Hospital of Tübingen

Tübingen, , Germany

Klinikum Nordoberpfalz AG, Klinikum Weiden

Weiden, , Germany

Beaumont Hospital

Dublin, , Ireland

San Raffaele Hospital

Milan, , Italy

Centro cardiologico Monzino

Milan, , Italy

Ospedaliero Universitaria Federico II

Naples, , Italy

Hagaziekenhuis

The Hague, , Netherlands

Elisabeth Tilburg Ziekenhuis

Tilburg, , Netherlands

Hospital Virgen Macarena

Seville, , Spain

Inselspital Bern

Bern, , Switzerland

Kantonsspital Luzern

Lucerne, , Switzerland

Royal Bournemouth Hospital

Bournemouth, , United Kingdom

Addenbrookes Hospital

Cambridge, , United Kingdom

Royal London Hospital

London, , United Kingdom

St.Thomas' Hospital

London, , United Kingdom

St. Mary's Hospital

London, , United Kingdom

Manchester University NHS Foundation Trust

Manchester, , United Kingdom

Freeman Hospital

Newcastle upon Tyne, , United Kingdom

Nottingham University Hospital

Nottingham, , United Kingdom

Countries

Austria; Belgium; France; Germany; Ireland; Italy; Netherlands; Spain; Switzerland; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 36254728 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan: Protocol

View Document

Document Type: Statistical Analysis Plan: Statistical Analysis Plan

View Document

Other Identifiers

S2366

Identifier Type: -

Identifier Source: org_study_id