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

Atherosclerosis Clinical Trial

— EMINENT  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02921230
• Other study ID #: S2366
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Arteriosclerosis
• Atherosclerosis
• Vascular Diseases

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