Clinical trial NCT02921230: Trial Comparing ELUVIA Versus Bare Metal Stent in Treatment of Superficial Femoral and/or Proximal Popliteal Artery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arterial Occlusive Diseases
Atherosclerosis
Vascular Diseases
Arteriosclerosis
Keywords: atherosclerosis
Superficial Femoral Artery (SFA)
Proximal Popliteal Artery (PPA)
stenting
paclitaxel
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2016-10-03
Enrollment: 775
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Subjects With Primary Patency at 12 Months Post-procedure
timeFrame: 12 Months
Secondary outcomes:
measure: Number of Subjects Walking Improvement - Distance at Baseline to 12 Months
timeFrame: 12 Months
measure: Number of Subjects Change in Quality of Life - Improvement From Baseline to 12 Month
timeFrame: 12 Months
measure: Cost Effectiveness
timeFrame: during index procedure, 1, 6, 12, 24 and 36 months
measure: Number of Subjects With Clinical Improvement at 12-months
timeFrame: 12 months
measure: Number of Subjects With Hemodynamic Improvement at 12-months
timeFrame: 12 months
Other outcomes:
measure: Number of Subjects With Walking Improvement at 1-month, 6-months, 12-months, 24-months, and 36-months
timeFrame: 1, 6, 12, 24, and 36 months
measure: Number of Subjects With Quality of Life Improvement at 1-month, 6-months, 24-months, and 36-months
timeFrame: 1, 6, 24, and 36 months
measure: Number of Subjects With Clinical Improvement at 1-month, 6-months, 24-months, and 36-months
timeFrame: 1, 6, 24, and 36 months
measure: Number of Subjects With Hemodynamic Improvement at 1-month, 6-months, 24-months, and 36-months
timeFrame: 1, 6, 24, and 36 months
measure: Primary Patency and Assisted Primary Patency
timeFrame: 6 and 12 months
measure: Adverse Event and Major Adverse Event (MAE) Rate
timeFrame: 1, 6, 12, 24, and 36 months
measure: Clinically-driven Target Lesion Revascularization (TLR) Rate
timeFrame: 1, 6, 12, 24, and 36 months
measure: Clinically-driven Target Vessel Revascularization (TVR) Rate
timeFrame: 1, 6, 12, 24 and 36 months
measure: Technical Success
timeFrame: during index procedure after stent delivered and deployed to the target lesion
measure: Procedural Success
timeFrame: within 24 hours of stenting procedure
measure: Number of Stent Fractures
timeFrame: 12 Months
Locations:
city: Innsbruck
country: Austria
facility: LKH Innsbruck
city: Klagenfurt
country: Austria
facility: Klinikum Klagenfurt
city: Vienna
country: Austria
facility: Allgemeines Krankenhaus Wien
city: Aalst
country: Belgium
facility: OLV Aalst
city: Antwerpen
country: Belgium
facility: ZiekenhuisNetwerk Antwerpen
city: Bonheiden
country: Belgium
facility: Imelda Hospital
city: Dendermonde
country: Belgium
facility: AZ Sint-Blasius
city: Edegem
country: Belgium
facility: UZ Antwerpen
city: Gent
country: Belgium
facility: UZ Gent
city: Leuven
country: Belgium
facility: UZ Leuven
city: Tienen
country: Belgium
facility: Regionaal Ziekenhuis Heilig Hart Tienen
city: Champigny-sur-Marne
country: France
facility: Hopital Privé Paul D'Egine
city: Clermont-Ferrand
country: France
facility: CHU - Hopital Gabriel Montpied
city: Créteil
country: France
facility: L'Hôpital Henri-Mondor
city: Dijon
country: France
facility: CHU Dijon
city: Lille
country: France
facility: CHU Lille
city: Lyon
country: France
facility: Hopital Edouard Herriot
city: Nancy
country: France
facility: CHU Nancy
city: Nantes
country: France
facility: Hopital Nord Laennec
city: Paris
country: France
facility: (Hôpital Européen Georges-Pompidou
city: Saint-Nazaire
country: France
facility: CH de Saint-Nazaire
city: Strasbourg
country: France
facility: CHU Strasbourg
city: Toulouse
country: France
facility: Clinique Pasteur
city: Valenciennes
country: France
facility: CH Valenciennes
city: Bad Krozingen
country: Germany
facility: Universitäts Herzzentrum
city: Berlin
country: Germany
facility: Sankt Gertrauden-Krankenhaus
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Freudenstadt
country: Germany
facility: Krankenhäuser Landkreis Freudenstadt GmbH
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Karlsbad
country: Germany
facility: SRH Klinikum Karlsbad-Langensteinbach
city: Kiel
country: Germany
facility: University Hospital Schleswig-Holstein Campus Kiel
city: Mainz
country: Germany
facility: University Medical Center of Johannes Gutenberg-Mainz
city: Marburg
country: Germany
facility: Universitätsklinikum Marburg
city: Munster
country: Germany
facility: St. Franziskus-Hospital Muenster
city: München
country: Germany
facility: Klinik Diakoniewerk München-Maxvorstadt
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Regensburg
country: Germany
facility: Krankenhaus Barmherzige Brüder
city: Rosenheim
country: Germany
facility: RoMed Klinikum Rosenheim
city: Sonneberg
country: Germany
facility: MEDINOS Kliniken Sonneberg GmbH
city: Torgau
country: Germany
facility: Krankenhaus Torgau
city: Tubingen
country: Germany
facility: University Hospital of Tübingen
city: Weiden
country: Germany
facility: Klinikum Nordoberpfalz AG, Klinikum Weiden
city: Dublin
country: Ireland
facility: Beaumont Hospital
city: Milan
country: Italy
facility: San Raffaele Hospital
city: Milan
country: Italy
facility: Centro cardiologico Monzino
city: Naples
country: Italy
facility: Ospedaliero Universitaria Federico II
city: Den Haag
country: Netherlands
facility: Hagaziekenhuis
city: Tilburg
country: Netherlands
facility: Elisabeth Tilburg Ziekenhuis
city: Sevilla
country: Spain
facility: Hospital Virgen Macarena
city: Bern
country: Switzerland
facility: Inselspital Bern
city: Luzern
country: Switzerland
facility: Kantonsspital Luzern
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
city: London
country: United Kingdom
facility: Royal London Hospital
city: London
country: United Kingdom
facility: St.Thomas' Hospital
city: London
country: United Kingdom
facility: St. Mary's Hospital
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust
city: Newcastle Upon Tyne
country: United Kingdom
facility: Freeman Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospital
Study officials:
affiliation: Sint-Franziskus-Hospital GmbH
name: Giovanni Torsello, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital St Joseph Paris
name: Yann Goueffic
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.