Trial Comparing ELUVIA Versus Bare Metal Stent in Treatment of Superficial Femoral and/or Proximal Popliteal Artery
- Conditions
- ArteriosclerosisArterial Occlusive DiseasesAtherosclerosisVascular Diseases
- Interventions
- Device: Peripheral stenting
- Registration Number
- NCT02921230
- Lead Sponsor
- Boston Scientific Corporation
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 775
-
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
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ELUVIA Stent Implantation Peripheral stenting Peripheral stenting control Bare Metal Stent Implantation Peripheral stenting Peripheral stenting
- Primary Outcome Measures
Name Time Method Number of Subjects With Primary Patency at 12 Months Post-procedure 12 Months 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.
- Secondary Outcome Measures
Name Time Method Number of Subjects Walking Improvement - Distance at Baseline to 12 Months 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.Number of Subjects Change in Quality of Life - Improvement From Baseline to 12 Month 12 Months 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.
Cost Effectiveness during index procedure, 1, 6, 12, 24 and 36 months Cost effectiveness of ELUVIA™ drug-eluting stent versus bare metal self-expanding nitinol stents.
Number of Subjects With Clinical Improvement at 12-months 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 baselineNumber of Subjects With Hemodynamic Improvement at 12-months 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
Trial Locations
- Locations (60)
Hospital Virgen Macarena
🇪🇸Sevilla, Spain
CHU Lille
🇫🇷Lille, France
CH de Saint-Nazaire
🇫🇷Saint-Nazaire, France
UZ Antwerpen
🇧🇪Edegem, Belgium
UZ Gent
🇧🇪Gent, Belgium
L'Hôpital Henri-Mondor
🇫🇷Créteil, France
Klinikum Klagenfurt
🇦🇹Klagenfurt, Austria
OLV Aalst
🇧🇪Aalst, Belgium
ZiekenhuisNetwerk Antwerpen
🇧🇪Antwerpen, Belgium
Elisabeth Tilburg Ziekenhuis
🇳🇱Tilburg, Netherlands
Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Germany
Krankenhaus Barmherzige Brüder
🇩🇪Regensburg, Germany
Krankenhaus Torgau
🇩🇪Torgau, Germany
LKH Innsbruck
🇦🇹Innsbruck, Austria
CHU Nancy
🇫🇷Nancy, France
CHU - Hopital Gabriel Montpied
🇫🇷Clermont-Ferrand, France
Hopital Nord Laennec
🇫🇷Nantes, France
Allgemeines Krankenhaus Wien
🇦🇹Vienna, Austria
Krankenhäuser Landkreis Freudenstadt GmbH
🇩🇪Freudenstadt, Germany
Hopital Edouard Herriot
🇫🇷Lyon, France
Universitätsklinikum Marburg
🇩🇪Marburg, Germany
Universitätsklinikum Bonn
🇩🇪Bonn, Germany
University Hospital Schleswig-Holstein Campus Kiel
🇩🇪Kiel, Germany
RoMed Klinikum Rosenheim
🇩🇪Rosenheim, Germany
CH Valenciennes
🇫🇷Valenciennes, France
Sankt Gertrauden-Krankenhaus
🇩🇪Berlin, Germany
Royal London Hospital
🇬🇧London, United Kingdom
SRH Klinikum Karlsbad-Langensteinbach
🇩🇪Karlsbad, Germany
CHU Strasbourg
🇫🇷Strasbourg, France
Hopital Privé Paul D'Egine
🇫🇷Champigny-sur-Marne, France
Universitätsklinikum Essen
🇩🇪Essen, Germany
St. Franziskus-Hospital Muenster
🇩🇪Munster, Germany
Universitäts Herzzentrum
🇩🇪Bad Krozingen, Germany
Universitätsklinikum Münster
🇩🇪Münster, Germany
Freeman Hospital
🇬🇧Newcastle Upon Tyne, United Kingdom
Kantonsspital Luzern
🇨🇭Luzern, Switzerland
San Raffaele Hospital
🇮🇹Milan, Italy
Manchester University NHS Foundation Trust
🇬🇧Manchester, United Kingdom
Hagaziekenhuis
🇳🇱Den Haag, Netherlands
Addenbrookes Hospital
🇬🇧Cambridge, United Kingdom
Nottingham University Hospital
🇬🇧Nottingham, United Kingdom
Royal Bournemouth Hospital
🇬🇧Bournemouth, United Kingdom
Inselspital Bern
🇨🇭Bern, Switzerland
St. Mary's Hospital
🇬🇧London, United Kingdom
Imelda Hospital
🇧🇪Bonheiden, Belgium
UZ Leuven
🇧🇪Leuven, Belgium
CHU Dijon
🇫🇷Dijon, France
(Hôpital Européen Georges-Pompidou
🇫🇷Paris, France
University Medical Center of Johannes Gutenberg-Mainz
🇩🇪Mainz, Germany
Centro cardiologico Monzino
🇮🇹Milan, Italy
University Hospital of Tübingen
🇩🇪Tubingen, Germany
Ospedaliero Universitaria Federico II
🇮🇹Naples, Italy
St.Thomas' Hospital
🇬🇧London, United Kingdom
Clinique Pasteur
🇫🇷Toulouse, France
Klinik Diakoniewerk München-Maxvorstadt
🇩🇪München, Germany
MEDINOS Kliniken Sonneberg GmbH
🇩🇪Sonneberg, Germany
Klinikum Nordoberpfalz AG, Klinikum Weiden
🇩🇪Weiden, Germany
AZ Sint-Blasius
🇧🇪Dendermonde, Belgium
Regionaal Ziekenhuis Heilig Hart Tienen
🇧🇪Tienen, Belgium
Beaumont Hospital
🇮🇪Dublin, Ireland