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

Primary Purpose

Arterial Occlusive Diseases, Atherosclerosis, Vascular Diseases

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Peripheral stenting
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arterial Occlusive Diseases focused on measuring atherosclerosis, Superficial Femoral Artery (SFA), Proximal Popliteal Artery (PPA), stenting, paclitaxel

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • LKH Innsbruck
  • Klinikum Klagenfurt
  • Allgemeines Krankenhaus Wien
  • OLV Aalst
  • ZiekenhuisNetwerk Antwerpen
  • Imelda Hospital
  • AZ Sint-Blasius
  • UZ Antwerpen
  • UZ Gent
  • UZ Leuven
  • Regionaal Ziekenhuis Heilig Hart Tienen
  • Hopital Privé Paul D'Egine
  • CHU - Hopital Gabriel Montpied
  • L'Hôpital Henri-Mondor
  • CHU Dijon
  • CHU Lille
  • Hopital Edouard Herriot
  • CHU Nancy
  • Hopital Nord Laennec
  • (Hôpital Européen Georges-Pompidou
  • CH de Saint-Nazaire
  • CHU Strasbourg
  • Clinique Pasteur
  • CH Valenciennes
  • Universitäts Herzzentrum
  • Sankt Gertrauden-Krankenhaus
  • Universitätsklinikum Bonn
  • Universitätsklinikum Essen
  • Krankenhäuser Landkreis Freudenstadt GmbH
  • Universitätsklinikum Heidelberg
  • SRH Klinikum Karlsbad-Langensteinbach
  • University Hospital Schleswig-Holstein Campus Kiel
  • University Medical Center of Johannes Gutenberg-Mainz
  • Universitätsklinikum Marburg
  • St. Franziskus-Hospital Muenster
  • Klinik Diakoniewerk München-Maxvorstadt
  • Universitätsklinikum Münster
  • Krankenhaus Barmherzige Brüder
  • RoMed Klinikum Rosenheim
  • MEDINOS Kliniken Sonneberg GmbH
  • Krankenhaus Torgau
  • University Hospital of Tübingen
  • Klinikum Nordoberpfalz AG, Klinikum Weiden
  • Beaumont Hospital
  • San Raffaele Hospital
  • Centro cardiologico Monzino
  • Ospedaliero Universitaria Federico II
  • Hagaziekenhuis
  • Elisabeth Tilburg Ziekenhuis
  • Hospital Virgen Macarena
  • Inselspital Bern
  • Kantonsspital Luzern
  • Royal Bournemouth Hospital
  • Addenbrookes Hospital
  • Royal London Hospital
  • St.Thomas' Hospital
  • St. Mary's Hospital
  • Manchester University NHS Foundation Trust
  • Freeman Hospital
  • Nottingham University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ELUVIA Stent Implantation

control Bare Metal Stent Implantation

Arm Description

Peripheral stenting

Peripheral stenting

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
Cost effectiveness
Cost effectiveness of ELUVIA™ drug-eluting stent versus bare metal self-expanding nitinol stents
Clinical improvement
Clinical improvement will be evaluated by assessing the changes in Rutherford Classification from baseline
Hemodynamic improvement
The hemodynamic improvement will be evaluated by assessing changes in Ankle-Brachial Index (ABI) from baseline

Full Information

First Posted
September 6, 2016
Last Updated
June 2, 2022
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02921230
Brief Title
Trial Comparing ELUVIA Versus Bare Metal Stent in Treatment of Superficial Femoral and/or Proximal Popliteal Artery
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 25, 2016 (Actual)
Primary Completion Date
July 2, 2021 (Actual)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arterial Occlusive Diseases, Atherosclerosis, Vascular Diseases, Arteriosclerosis
Keywords
atherosclerosis, Superficial Femoral Artery (SFA), Proximal Popliteal Artery (PPA), stenting, paclitaxel

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
775 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ELUVIA Stent Implantation
Arm Type
Experimental
Arm Description
Peripheral stenting
Arm Title
control Bare Metal Stent Implantation
Arm Type
Active Comparator
Arm Description
Peripheral stenting
Intervention Type
Device
Intervention Name(s)
Peripheral stenting
Intervention Description
stent implantation during the index procedure
Primary Outcome Measure Information:
Title
Primary Patency at 12 months post-procedure
Description
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.
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Walking Improvement
Description
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
Time Frame
12 Months
Title
Change in quality of life
Description
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
Time Frame
12 Months
Title
Cost effectiveness
Description
Cost effectiveness of ELUVIA™ drug-eluting stent versus bare metal self-expanding nitinol stents
Time Frame
during index procedure, 1, 6, 12, 24 and 36 months
Title
Clinical improvement
Description
Clinical improvement will be evaluated by assessing the changes in Rutherford Classification from baseline
Time Frame
12 months
Title
Hemodynamic improvement
Description
The hemodynamic improvement will be evaluated by assessing changes in Ankle-Brachial Index (ABI) from baseline
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Walking Improvement
Description
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
Time Frame
1, 6, 24 and 36 months
Title
Quality of Life Improvement
Description
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
Time Frame
1, 24 and 36 months
Title
Clinical improvement
Description
Clinical improvement will be evaluated by assessing the changes in Rutherford Classification from baseline
Time Frame
1, 6, 24 and 36 months
Title
Hemodynamic improvement
Description
The hemodynamic improvement will be evaluated by assessing changes in Ankle-Brachial Index (ABI) from baseline
Time Frame
1, 6, 24 and 36 months
Title
Primary Patency
Description
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.
Time Frame
6, 12, 24 and 36 months
Title
Adverse Event and Major Adverse Event (MAE) rate
Description
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
Time Frame
1, 6, 12, 24, 36, 48, and 60 months
Title
Clinically-driven Target Lesion Revascularization (TLR) Rate
Description
Target Lesion Revascularization is defined as any surgical or percutaneous intervention to the target lesion(s) after the index procedure
Time Frame
1, 6, 12, 24, 36, 48, and 60 months
Title
Clinically-driven Target Vessel Revascularization (TVR) Rate
Description
Target Vessel Revascularization is defined as any surgical or percutaneous intervention to the target vessel after the index procedure
Time Frame
1, 6, 12, 24, 36, 48, and 60 months
Title
Technical success
Description
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
Time Frame
during index procedure
Title
Procedural success
Description
Procedural success defined as technical success with no MAEs noted within 24 hours of the index procedure
Time Frame
within 24 hours of stenting procedure
Title
Number of Stent Fractures
Description
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
Time Frame
12 and 24 months
Title
Survival Rate
Description
Telephone follow-up visit and/or medical chart review and/or publicly available records consultation for vital status
Time Frame
48 and 60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giovanni Torsello, MD
Organizational Affiliation
Sint-Franziskus-Hospital GmbH
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yann Goueffic
Organizational Affiliation
Hôpital St Joseph Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
LKH Innsbruck
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Klinikum Klagenfurt
City
Klagenfurt
ZIP/Postal Code
9020
Country
Austria
Facility Name
Allgemeines Krankenhaus Wien
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
OLV Aalst
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
ZiekenhuisNetwerk Antwerpen
City
Antwerpen
ZIP/Postal Code
2000
Country
Belgium
Facility Name
Imelda Hospital
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Facility Name
AZ Sint-Blasius
City
Dendermonde
ZIP/Postal Code
9200
Country
Belgium
Facility Name
UZ Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Regionaal Ziekenhuis Heilig Hart Tienen
City
Tienen
ZIP/Postal Code
3300
Country
Belgium
Facility Name
Hopital Privé Paul D'Egine
City
Champigny-sur-Marne
ZIP/Postal Code
94500
Country
France
Facility Name
CHU - Hopital Gabriel Montpied
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
L'Hôpital Henri-Mondor
City
Créteil
Country
France
Facility Name
CHU Dijon
City
Dijon
ZIP/Postal Code
77908
Country
France
Facility Name
CHU Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Hopital Edouard Herriot
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
CHU Nancy
City
Nancy
ZIP/Postal Code
54500
Country
France
Facility Name
Hopital Nord Laennec
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
(Hôpital Européen Georges-Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
CH de Saint-Nazaire
City
Saint-Nazaire
ZIP/Postal Code
44606
Country
France
Facility Name
CHU Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Clinique Pasteur
City
Toulouse
ZIP/Postal Code
31300
Country
France
Facility Name
CH Valenciennes
City
Valenciennes
ZIP/Postal Code
59322
Country
France
Facility Name
Universitäts Herzzentrum
City
Bad Krozingen
ZIP/Postal Code
79189
Country
Germany
Facility Name
Sankt Gertrauden-Krankenhaus
City
Berlin
ZIP/Postal Code
10713
Country
Germany
Facility Name
Universitätsklinikum Bonn
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Universitätsklinikum Essen
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Krankenhäuser Landkreis Freudenstadt GmbH
City
Freudenstadt
ZIP/Postal Code
72250
Country
Germany
Facility Name
Universitätsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
SRH Klinikum Karlsbad-Langensteinbach
City
Karlsbad
ZIP/Postal Code
76307
Country
Germany
Facility Name
University Hospital Schleswig-Holstein Campus Kiel
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
University Medical Center of Johannes Gutenberg-Mainz
City
Mainz
Country
Germany
Facility Name
Universitätsklinikum Marburg
City
Marburg
ZIP/Postal Code
35043
Country
Germany
Facility Name
St. Franziskus-Hospital Muenster
City
Munster
ZIP/Postal Code
48145
Country
Germany
Facility Name
Klinik Diakoniewerk München-Maxvorstadt
City
München
ZIP/Postal Code
80799
Country
Germany
Facility Name
Universitätsklinikum Münster
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Krankenhaus Barmherzige Brüder
City
Regensburg
ZIP/Postal Code
93049
Country
Germany
Facility Name
RoMed Klinikum Rosenheim
City
Rosenheim
ZIP/Postal Code
83022
Country
Germany
Facility Name
MEDINOS Kliniken Sonneberg GmbH
City
Sonneberg
Country
Germany
Facility Name
Krankenhaus Torgau
City
Torgau
ZIP/Postal Code
04860
Country
Germany
Facility Name
University Hospital of Tübingen
City
Tubingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Klinikum Nordoberpfalz AG, Klinikum Weiden
City
Weiden
Country
Germany
Facility Name
Beaumont Hospital
City
Dublin
Country
Ireland
Facility Name
San Raffaele Hospital
City
Milan
ZIP/Postal Code
20132
Country
Italy
Facility Name
Centro cardiologico Monzino
City
Milan
ZIP/Postal Code
20138
Country
Italy
Facility Name
Ospedaliero Universitaria Federico II
City
Naples
Country
Italy
Facility Name
Hagaziekenhuis
City
Den Haag
ZIP/Postal Code
2545
Country
Netherlands
Facility Name
Elisabeth Tilburg Ziekenhuis
City
Tilburg
ZIP/Postal Code
5022 GC
Country
Netherlands
Facility Name
Hospital Virgen Macarena
City
Sevilla
ZIP/Postal Code
41007
Country
Spain
Facility Name
Inselspital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Kantonsspital Luzern
City
Luzern
ZIP/Postal Code
6000
Country
Switzerland
Facility Name
Royal Bournemouth Hospital
City
Bournemouth
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
Addenbrookes Hospital
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Royal London Hospital
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
St.Thomas' Hospital
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
St. Mary's Hospital
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom
Facility Name
Manchester University NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
Freeman Hospital
City
Newcastle Upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Nottingham University Hospital
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36254728
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.
Results Reference
derived

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

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