ELUVIA™ Drug-eluting Stent Versus Zilver® PTX® Stent (IMPERIAL)

April 10, 2023 updated by: Boston Scientific Corporation

A Randomized Trial Comparing the ELUVIA™ Drug-eluting Stent Versus Zilver® PTX® Stent for Treatment of Superficial Femoral and/or Proximal Popliteal Arteries

The primary objective of this trial is to evaluate the safety and effectiveness of the Boston Scientific Corporation (BSC) 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.

Long Lesion Substudy: to evaluate the safety and effectiveness of the Boston Scientific Corporation (BSC) ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions >140 mm and ≤ 190 mm in length.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Atherosclerosis is a systemic disease that has become increasingly recognized in the expanding elderly population as a significant cause of morbidity and mortality. Atherosclerosis in the vessels of the lower extremities can cause a variety of symptoms ranging from intermittent claudication to ischemic rest pain and critical ischemia with major tissue loss. Typically, femoropopliteal lesions have been difficult to successfully treat with endovascular therapy because the disease is often diffuse and located in an area of the body subject to significant mobility stresses such as extension, contraction, compression, elongation, flexion and torsion.

The IMPERIAL trial is a global, prospective, multi-center trial. Approximately 525-535 subjects will be enrolled at up to 75 study centers worldwide. Regions participating include the United States, Canada, European Union, Japan and New Zealand.

The trial consists of a prospective, multicenter, 2:1 randomized (ELUVIA vs Zilver PTX), controlled, single-blind, non-inferiority trial (RCT), a concurrent, non-blinded, non-randomized, single-arm, pharmacokinetic (PK) substudy and a concurrent, non-blinded, non-randomized, Long Lesion substudy.

Study Type

Interventional

Enrollment (Actual)

524

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria
        • Medical University Graz, Department of Radiology
      • Vienna, Austria
        • Hanusch Hospital
      • Vienna, Austria
        • Allgemeines Krankenhaus AKH
  • Belgium
      • Genk, Belgium
        • Ziekenhuis Oost Limburg
      • Gent, Belgium, 9000
        • Universitair Ziekenhuis Gent
      • Tienen, Belgium, 3300
        • Regionaal Ziekenhuis Heilig Hart Tienen
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X6
        • Toronto General Hospital
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Fleurimont Hospital
  • Germany
      • Bad Krozingen, Germany
        • Universitäts-Herzzentrum Bad Krozingen
      • Berlin, Germany
        • Vivantes Klinikum Neukölln
      • Berlin, Germany
        • Center for Diagnostic Radiology and Minimally Invasive Therapy at The Jewish Hospital Berlin
      • Flensburg, Germany
        • Ev. Luth. Diakonissenanstalt Flensburg
      • Leipzig, Germany
        • Universität Leipzig
  • Japan
      • Fukuoka, Japan
        • Fukuoka Sanno Hospital
      • Osaka, Japan
        • Morinomiya Hospital
    • Fukuoka
      • Kitakyushu, Fukuoka, Japan
        • Kokura Memorial Hospital
    • Hyogo
      • Amagasaki, Hyogo, Japan
        • Kansai Rosai Hospital
    • Kanagawa
      • Kawasaki, Kanagawa, Japan
        • Takatsu General Hospital
      • Yokohama, Kanagawa, Japan
        • Saiseikai Yokohama-City Eastern Hospital
    • Nara
      • Kashihara-shi, Nara, Japan
        • Nara Medical University Hospital
    • Osaka
      • Kishiwada, Osaka, Japan
        • Kishiwada Tokushukai Hospital
    • Tokyo
      • Meguro, Tokyo, Japan
        • Toho University Ohashi Medical Center
      • Minato, Tokyo, Japan
        • The jikei University Hospital
  • New Zealand
      • Auckland, New Zealand
        • Auckland City Hospital
      • Auckland, New Zealand
        • Middlemore Hospital
      • Hamilton, New Zealand
        • Clinical Trials NZ
  • United States
    • Arizona
      • Yuma, Arizona, United States, 85364
        • Yuma Regional Medical Center
    • California
      • Sacramento, California, United States, 95817
        • University of California, Davis Medical Center
    • Florida
      • Gainesville, Florida, United States, 32605
        • Florida Research Network, LLC
      • Jacksonville, Florida, United States, 32216
        • First Coast Cardiovascular Institute
      • Miami, Florida, United States, 33176
        • Baptist Cardiac and Vascular Institute
      • Miami Beach, Florida, United States, 33140
        • Mount Sinai Medical Center
      • Ocala, Florida, United States, 34471
        • MediQuest Research at Munroe Regional Medical Center
      • Pensacola, Florida, United States, 32501
        • Baptist Hospital
    • Georgia
      • Augusta, Georgia, United States, 30901
        • University Hospital
    • Illinois
      • Oak Lawn, Illinois, United States, 60453
        • Advocate Christ Medical Center
      • Peoria, Illinois, United States, 61614
        • St. Francis Medical Center
    • Indiana
      • Fort Wayne, Indiana, United States, 46802
        • St. Joseph Hospital
    • Maine
      • Portland, Maine, United States, 04102
        • Maine Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02135
        • Steward St. Elizabeth's Medical Center of Boston, Inc.
    • Michigan
      • Petoskey, Michigan, United States, 49770
        • Northern Michigan Hospital
    • Minnesota
      • Coon Rapids, Minnesota, United States, 55433
        • Mercy Hospital
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Foundation
    • Nebraska
      • Omaha, Nebraska, United States, 68124
        • Alegent Creighton Health Bergan Mercy Medical Center
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • New Mexico Heart Institute, PA
    • New York
      • Brooklyn, New York, United States, 11219
        • Maimonides Medical Center
      • New York, New York, United States, 10016
        • New York University Medical Center
      • New York, New York, United States, 10032
        • New York Presbyterian Hospital-Columbia University Medical Center
    • North Carolina
      • Concord, North Carolina, United States, 28025
        • Carolinas HealthCare System NorthEast
      • Raleigh, North Carolina, United States, 27607
        • Rex Hospital
    • Ohio
      • Canton, Ohio, United States, 44710
        • Aultman Hospital
      • Toledo, Ohio, United States, 43614
        • University of Toledo Medical Center
      • Willoughby, Ohio, United States, 44094-4662
        • LakeWest Hospital/Northeast Ohio Vascular Associates, Inc.
    • Oregon
      • Portland, Oregon, United States, 97225
        • Providence St. Vincents Medical Center
    • Pennsylvania
      • Bryn Mawr, Pennsylvania, United States, 19010
        • Lankenau Institute for Medical Research
      • Philadelphia, Pennsylvania, United States, 19141
        • Albert Einstein Medical Center
      • Wormleysburg, Pennsylvania, United States, 17043
        • Pinnacle Health Cardiovascular Institute
      • York, Pennsylvania, United States, 17405
        • York Hospital
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57108
        • Avera Heart Hospital of South Dakota
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • University Surgical Associates
      • Jackson, Tennessee, United States, 38301
        • Jackson-Madison County General Hospital
      • Nashville, Tennessee, United States, 37205
        • St. Thomas Research Institute, LLC
    • Texas
      • Dallas, Texas, United States, 75231
        • Texas Health Presbyterian Hospital
      • Houston, Texas, United States, 77030
        • The Methodist Hospital Research Institute
      • Plano, Texas, United States, 75093
        • The Heart Hospital Baylor Plano
    • Wisconsin
      • Wausau, Wisconsin, United States, 54401
        • Aspirus Heart and Vascular Institute - Research and Education

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subjects age 18 and older.
  2. Subject (or Legal Guardian if applicable) 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. NOTE: For subjects less than 20 years of age enrolled at a Japanese center, the subject's legal representative, as well as the subject, must provide written informed consent.
  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 SFA and/or 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 ≤ 140 mm (Note: Lesion segment(s) must be fully covered with one ELUVIA stent or up to two Zilver PTX stents)
    • Long Lesion Substudy: Total lesion length (or series of lesions) >140 mm and ≤ 190 mm (Note: Lesion segment(s) will require overlapping of two ELUVIA stents).
    • For occlusive lesions requiring use of re-entry device, lesion length ≤ 120 mm
    • Long Lesion Substudy: For occlusive lesions requiring use of re-entry device, lesion length > 120 mm and ≤ 170 mm
    • 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 <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 trial, limit the subject's compliance with the follow-up requirements, or impact the scientific integrity of the clinical trial.
  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 investigational 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 <80,000 mm3 or >600,000 mm3 or history of bleeding diathesis.
  10. Concomitant renal failure with a serum creatinine >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 another 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 within 30 days of randomization/enrollment.
  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ELUVIA Stent Implantation
Percutaneous stent placement in the SFA/PPA
Device: ELUVIA (Stent Implantation)
Drug-eluting self-expanding stent implantation during the index procedure.
Active Comparator: Zilver PTX Stent Implantation
Percutaneous stent placement in the SFA/PPA
Device: Zilver PTX (Stent Implantation)
Drug-eluting self-expanding stent implantation during the index procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Major Adverse Events (MAEs)
Time Frame: 12 Months
MAEs defined as all causes of death through 1 month, target limb major amputation through 12 months and/or target lesion revascularization (TLR) through 12 months
12 Months
Number of Participants Reaching Primary Patency
Time Frame: 12 Months
Primary patency of target lesion at 12-months assessed by duplex ultrasound and adjudicated by an independent core laboratory
12 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of CEC-adjudicated Events Through 12 Months
Time Frame: 12 Months
Denominators for the cumulative rate will be based on 1) subjects with events, and 2) subjects with no events but their follow-up time reach on (or beyond) the earliest visit window.
12 Months
Count of Participants Meeting Primary Sustained Clinical Improvement
Time Frame: 12 Months
Defined as improvement in Rutherford classification (defined as chronic, symptomatic lower limb ischemia in categories 2, 3 or 4) by one or more categories compared with baseline, without target lesion revascularization.
12 Months
Number of Participants With Hemodynamic Improvement
Time Frame: 12 Months
Defined as an increase in the ankle-brachial index by greater than of equal to 0.10 compared with baseline or to an ankle-brachial index of greater than or equal to 0.90, without need for repeat target lesion revascularization.
12 Months
Walking Impairment Questionnaire (WIQ) Scores
Time Frame: Baseline to 12 Months
The WIQ is a functional-assessment questionnaire that evaluates walking ability with regard to speed, distance and stair climbing ability as well as the reasons that walking ability might be limited. Range of scores is between 0% and 100% with 100% being the best and 0% being the worst score. WIQ scores reported as change from baseline.
Baseline to 12 Months
6-Minute Walk Test - Distance Walked
Time Frame: Change in baseline to 12-Months
Change in distance walked from baseline to 12 months.
Change in baseline to 12-Months
6-Minute Walk Test - Speed
Time Frame: Baseline to 12 months
Change in speed walked from baseline to 12 months
Baseline to 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom From Major Adverse Events
Time Frame: Through 60 Months
Percentage of participants without Major Adverse Events (MAEs)
Through 60 Months
Clinical Events Committee Adjudicated Clinically-Driven Target Lesion Revascularization Rate
Time Frame: Through 60 Months
Clinical Events Committee (CEC) adjudicated clinically-driven target lesion revascularization rate
Through 60 Months
Percentage of Participants With Target Limb Major Amputation
Time Frame: Through 60 Months
Clinical Events Committee (CEC) adjudicated target limb major amputation rate
Through 60 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

  • Principal Investigator: William Gray, MD, Main Line Health
  • Principal Investigator: Stefan Müller-Hülsbeck, Prof, Ev. Luth. Diakonissenanstalt Flensburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2015

Primary Completion (Actual)

December 28, 2017

Study Completion (Actual)

April 12, 2022

Study Registration Dates

First Submitted

September 22, 2015

First Submitted That Met QC Criteria

October 13, 2015

First Posted (Estimate)

October 14, 2015

Study Record Updates

Last Update Posted (Actual)

May 8, 2023

Last Update Submitted That Met QC Criteria

April 10, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S2063

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make IPD available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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