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

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ClinicalTrials.gov Identifier: NCT02921230
Recruitment Status : Recruiting
First Posted : October 3, 2016
Last Update Posted : May 16, 2018
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

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.

Condition or disease Intervention/treatment Phase
Arterial Occlusive Diseases Atherosclerosis Vascular Diseases Arteriosclerosis Device: Peripheral stenting Not Applicable

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 30-140 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 140 mm in length when compared against bare metal stents, and collect additional data including health economics data.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : October 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : May 2021

Arm Intervention/treatment
Experimental: ELUVIA Stent Implantation
Peripheral stenting
Device: Peripheral stenting
stent implantation during the index procedure

Active Comparator: control Bare Metal Stent Implantation
Peripheral stenting
Device: Peripheral stenting
stent implantation during the index procedure




Primary Outcome Measures :
  1. Primary Patency at 12 months post-procedure [ Time Frame: 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.

    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 :
  1. Walking Improvement [ Time Frame: 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

  2. Change in quality of life [ Time Frame: 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

  3. Health care costs [ Time Frame: during index procedure, 1, 6, 12, 24 and 36 months ]
    To evaluate the health care costs and compare it between the 2 study arms, health care costs associated with index procedure and changes in healthcare utilization over time and associated health care costs will be collected

  4. Clinical improvement [ Time Frame: 12 months ]
    Clinical improvement will be evaluated by assessing the changes in Rutherford Classification from baseline

  5. Hemodynamic improvement [ Time Frame: 12 months ]
    The hemodynamic improvement will be evaluated by assessing changes in Ankle-Brachial Index (ABI) from baseline


Other Outcome Measures:
  1. Walking Improvement [ Time Frame: 1, 6, 24 and 36 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

  2. Quality of Life Improvement [ Time Frame: 1, 9, 24 and 36 months ]
    Quality of Life Improvement will be assessed at 1 month, 6 months, 9 months, 24 months and 36 months by evaluating the change in EQ-5D-5L™ from baseline

  3. Clinical improvement [ Time Frame: 1, 6, 24 and 36 months ]
    Clinical improvement will be evaluated by assessing the changes in Rutherford Classification from baseline

  4. Hemodynamic improvement [ Time Frame: 1, 6, 24 and 36 months ]
    The hemodynamic improvement will be evaluated by assessing changes in Ankle-Brachial Index (ABI) from baseline

  5. Primary Patency [ Time Frame: 6, 12, 24 and 36 months ]
    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. Adverse Event and Major Adverse Event (MAE) rate [ Time Frame: 1, 6, 12, 24 and 36 months ]
    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

  7. Clinically-driven Target Lesion Revascularization (TLR) Rate [ Time Frame: 1, 6, 12, 24 and 36 months ]
    Target Lesion Revascularization is defined as any surgical or percutaneous intervention to the target lesion(s) after the index procedure

  8. Clinically-driven Target Vessel Revascularization (TVR) Rate [ Time Frame: 1, 6, 12, 24 and 36 months ]
    Target Vessel Revascularization is defined as any surgical or percutaneous intervention to the target vessel after the index procedure

  9. Technical success [ Time Frame: during index procedure ]
    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

  10. Procedural success [ Time Frame: within 24 hours of stenting procedure ]
    Procedural success defined as technical success with no MAEs noted within 24 hours of the index procedure

  11. Number of Stent Fractures [ Time Frame: 12 and 24 months ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 ≤140 mm (Note: Lesion segment(s) must be fully covered with one ELUVIA stent or Self Expanding Bare Nitinol stent)
    4. For occlusive lesions requiring use of re-entry device, lesion length ≤ 120 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 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 3 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02921230


Contacts
Contact: An Goethals +3232900306 an.goethals@genae.com
Contact: Angela Schutt +17634942166 angela.schutt@bsci.com

  Show 68 Study Locations
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Giovanni Torsello, MD Sint-Franziskus-Hospital GmbH
Principal Investigator: Yann Goueffic CHU de Nantes, hôpital Nord Laennec

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT02921230     History of Changes
Other Study ID Numbers: S2366
First Posted: October 3, 2016    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Boston Scientific Corporation:
atherosclerosis
Superficial Femoral Artery (SFA)
Proximal Popliteal Artery (PPA)
stenting
paclitaxel

Additional relevant MeSH terms:
Atherosclerosis
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Cardiovascular Diseases