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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02921230
Other study ID # S2366
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 25, 2016
Est. completion date April 2025

Study information

Verified date June 2022
Source Boston Scientific Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

The EMINENT study is a prospective, multi-center study confirming the superior 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 confirm the superior 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 information / eligibility

Status Active, not recruiting
Enrollment 775
Est. completion date April 2025
Est. primary completion date July 2, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Device:
Peripheral stenting
stent implantation during the index procedure

Locations

Country Name City State
Austria LKH Innsbruck Innsbruck
Austria Klinikum Klagenfurt Klagenfurt
Austria Allgemeines Krankenhaus Wien Vienna
Belgium OLV Aalst Aalst
Belgium ZiekenhuisNetwerk Antwerpen Antwerpen
Belgium Imelda Hospital Bonheiden
Belgium AZ Sint-Blasius Dendermonde
Belgium UZ Antwerpen Edegem
Belgium UZ Gent Gent
Belgium UZ Leuven Leuven
Belgium Regionaal Ziekenhuis Heilig Hart Tienen Tienen
France 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
Germany 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 Munster
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 Tubingen
Germany Klinikum Nordoberpfalz AG, Klinikum Weiden Weiden
Ireland Beaumont Hospital Dublin
Italy Centro cardiologico Monzino Milan
Italy San Raffaele Hospital Milan
Italy Ospedaliero Universitaria Federico II Naples
Netherlands Hagaziekenhuis Den Haag
Netherlands Elisabeth Tilburg Ziekenhuis Tilburg
Spain Hospital Virgen Macarena Sevilla
Switzerland Inselspital Bern Bern
Switzerland Kantonsspital Luzern Luzern
United Kingdom Royal Bournemouth Hospital Bournemouth
United Kingdom Addenbrookes Hospital Cambridge
United Kingdom Royal London Hospital London
United Kingdom St. Mary's Hospital London
United Kingdom St.Thomas' Hospital London
United Kingdom Manchester University NHS Foundation Trust Manchester
United Kingdom Freeman Hospital Newcastle Upon Tyne
United Kingdom Nottingham University Hospital Nottingham

Sponsors (1)

Lead Sponsor Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

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

Outcome

Type Measure Description Time frame Safety issue
Other Walking Improvement 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 1, 6, 24 and 36 months
Other Quality of Life Improvement Quality of Life Improvement will be assessed at 1 month, 6 months, 24 months and 36 months by evaluating the change in EQ-5D-5L™ from baseline 1, 24 and 36 months
Other Clinical improvement Clinical improvement will be evaluated by assessing the changes in Rutherford Classification from baseline 1, 6, 24 and 36 months
Other Hemodynamic improvement The hemodynamic improvement will be evaluated by assessing changes in Ankle-Brachial Index (ABI) from baseline 1, 6, 24 and 36 months
Other Primary Patency Primary vessel patency is defined as a binary endpoint and will be determined to be a success when the duplex ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) is = 2.4 at follow-up visit in the absence of clinically-driven TLR or bypass of the target lesion. All DUS readings will be assessed by an independent core laboratory. 6, 12, 24 and 36 months
Other Adverse Event and Major Adverse Event (MAE) rate Adverse Event rate and Major Adverse Event, defined as all causes of death, target limb major amputation and/or Target Lesion Revascularization, rate at each time point 1, 6, 12, 24, 36, 48, and 60 months
Other Clinically-driven Target Lesion Revascularization (TLR) Rate Target Lesion Revascularization is defined as any surgical or percutaneous intervention to the target lesion(s) after the index procedure 1, 6, 12, 24, 36, 48, and 60 months
Other Clinically-driven Target Vessel Revascularization (TVR) Rate Target Vessel Revascularization is defined as any surgical or percutaneous intervention to the target vessel after the index procedure 1, 6, 12, 24, 36, 48, and 60 months
Other Technical success Technical success defined as delivery and deployment of the assigned study stent to the target lesion to achieve residual angiographic stenosis no greater than 30% assessed visually during index procedure
Other Procedural success Procedural success defined as technical success with no MAEs noted within 24 hours of the index procedure within 24 hours of stenting procedure
Other Number of Stent Fractures Number of Stent Fractures reported at 12 months and 24 months utilizing the Vascular InterVentional Advances (VIVA) definitions assessed by the x-ray core laboratory 12 and 24 months
Other Survival Rate Telephone follow-up visit and/or medical chart review and/or publicly available records consultation for vital status 48 and 60 months
Primary 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.
Primary vessel patency is defined as a binary endpoint and will be determined to be a success when the duplex ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) is = 2.4 at the 12-month follow-up visit in the absence of clinically-driven TLR or bypass of the target lesion. All DUS readings will be assessed by an independent core laboratory.
12 Months
Secondary Walking Improvement 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 12 Months
Secondary Change in quality of life 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 12 Months
Secondary Cost effectiveness Cost effectiveness of ELUVIA™ drug-eluting stent versus bare metal self-expanding nitinol stents during index procedure, 1, 6, 12, 24 and 36 months
Secondary Clinical improvement Clinical improvement will be evaluated by assessing the changes in Rutherford Classification from baseline 12 months
Secondary Hemodynamic improvement The hemodynamic improvement will be evaluated by assessing changes in Ankle-Brachial Index (ABI) from baseline 12 months
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