AzTrials
AzTrials

Atherosclerosis of Native Arteries of the ExtremitiesIMPERIALNCT02574481

ELUVIA™ Drug-eluting Stent Versus Zilver® PTX® Stent

A study testing ELUVIA (Stent Implantation) and Zilver PTX (Stent Implantation) in people with Atherosclerosis of Native Arteries of the Extremities, run by Boston Scientific Corporation at 68 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ELUVIA (Stent Implantation) and Zilver PTX (Stent Implantation)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
524 participants
Where
68 sitesin 7 countries
Study dates
Dec 2015to 12 Apr 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects age 18 and older.
  • 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.
  • Chronic, symptomatic lower limb ischemia defined as Rutherford categories 2, 3 or 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
Show all 12Show fewer
  • 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
  • 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.

Who cannot join

  • Previously stented target lesion/vessel.
  • Target lesion/vessel previously treated with drug-coated balloon <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 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 trial, limit the subject's compliance with the follow-up requirements, or impact the scientific integrity of the clinical trial.
Show all 21Show fewer
  • Known hypersensitivity or contraindication to contrast dye that, in the opinion of the investigator, cannot be adequately pre-medicated.
  • 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).
  • Platelet count <80,000 mm3 or >600,000 mm3 or history of bleeding diathesis.
  • Concomitant renal failure with a serum creatinine >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 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).
  • Septicemia at the time of randomization/enrollment.
  • Presence of other hemodynamically significant outflow lesions in the target limb requiring intervention within 30 days of randomization/enrollment.
  • 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.

Trial locations and contacts

68 sites in 7 countries.

68 sites in 7 countries

United States42 sites

  • New Mexico Heart Institute, PA

    Albuquerque, New Mexico, 87102

  • University Hospital

    Augusta, Georgia, 30901

  • Steward St. Elizabeth's Medical Center of Boston, Inc.

    Boston, Massachusetts, 02135

  • Maimonides Medical Center

    Brooklyn, New York, 11219

  • Lankenau Institute for Medical Research

    Bryn Mawr, Pennsylvania, 19010

  • Aultman Hospital

    Canton, Ohio, 44710

  • University Surgical Associates

    Chattanooga, Tennessee, 37403

  • Carolinas HealthCare System NorthEast

    Concord, North Carolina, 28025

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Texas Health Presbyterian Hospital

    Dallas, Texas, 75231

  • St. Joseph Hospital

    Fort Wayne, Indiana, 46802

  • Florida Research Network, LLC

    Gainesville, Florida, 32605

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • The Methodist Hospital Research Institute

    Houston, Texas, 77030

  • Jackson-Madison County General Hospital

    Jackson, Tennessee, 38301

  • First Coast Cardiovascular Institute

    Jacksonville, Florida, 32216

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Baptist Cardiac and Vascular Institute

    Miami, Florida, 33176

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • St. Thomas Research Institute, LLC

    Nashville, Tennessee, 37205

  • New York University Medical Center

    New York, New York, 10016

  • New York Presbyterian Hospital-Columbia University Medical Center

    New York, New York, 10032

  • Advocate Christ Medical Center

    Oak Lawn, Illinois, 60453

  • MediQuest Research at Munroe Regional Medical Center

    Ocala, Florida, 34471

  • Alegent Creighton Health Bergan Mercy Medical Center

    Omaha, Nebraska, 68124

  • Baptist Hospital

    Pensacola, Florida, 32501

  • St. Francis Medical Center

    Peoria, Illinois, 61614

  • Northern Michigan Hospital

    Petoskey, Michigan, 49770

  • Albert Einstein Medical Center

    Philadelphia, Pennsylvania, 19141

  • The Heart Hospital Baylor Plano

    Plano, Texas, 75093

  • Maine Medical Center

    Portland, Maine, 04102

  • Providence St. Vincents Medical Center

    Portland, Oregon, 97225

  • Rex Hospital

    Raleigh, North Carolina, 27607

  • Mayo Clinic Foundation

    Rochester, Minnesota, 55905

  • University of California, Davis Medical Center

    Sacramento, California, 95817

  • Avera Heart Hospital of South Dakota

    Sioux Falls, South Dakota, 57108

  • University of Toledo Medical Center

    Toledo, Ohio, 43614

  • Aspirus Heart and Vascular Institute - Research and Education

    Wausau, Wisconsin, 54401

  • LakeWest Hospital/Northeast Ohio Vascular Associates, Inc.

    Willoughby, Ohio, 44094-4662

  • Pinnacle Health Cardiovascular Institute

    Wormleysburg, Pennsylvania, 17043

  • York Hospital

    York, Pennsylvania, 17405

  • Yuma Regional Medical Center

    Yuma, Arizona, 85364

Other trials in United States

Japan10 sites

  • Kansai Rosai Hospital

    Amagasaki, Hyōgo

  • Fukuoka Sanno Hospital

    Fukuoka

  • Nara Medical University Hospital

    Kashihara-shi, Nara

  • Takatsu General Hospital

    Kawasaki, Kanagawa

  • Kishiwada Tokushukai Hospital

    Kishiwada, Osaka

  • Kokura Memorial Hospital

    Kitakyushu, Fukuoka

  • Toho University Ohashi Medical Center

    Meguro City, Tokyo

  • The Jikei University Hospital

    Minato, Tokyo

  • Morinomiya Hospital

    Osaka

  • Saiseikai Yokohama-City Eastern Hospital

    Yokohama, Kanagawa

Other trials in Japan

Germany5 sites

  • Universitäts-Herzzentrum Bad Krozingen

    Bad Krozingen

  • Center for Diagnostic Radiology and Minimally Invasive Therapy at The Jewish Hospital Berlin

    Berlin

  • Vivantes Klinikum Neukölln

    Berlin

  • Ev. Luth. Diakonissenanstalt Flensburg

    Flensburg

  • Universität Leipzig

    Leipzig

Other trials in Germany

Austria3 sites

  • Medical University Graz, Department of Radiology

    Graz

  • Allgemeines Krankenhaus AKH

    Vienna

  • Hanusch Hospital

    Vienna

Other trials in Austria

Belgium3 sites

  • Ziekenhuis oost Limburg

    Genk

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • Regionaal Ziekenhuis Heilig Hart Tienen

    Tienen, 3300

Other trials in Belgium

New Zealand3 sites

  • Auckland City Hospital

    Auckland

  • Middlemore Hospital

    Auckland

  • Clinical Trials NZ

    Hamilton

Other trials in New Zealand

Canada2 sites

  • Fleurimont Hospital

    Sherbrooke, Quebec, J1H 5N4

  • Toronto General Hospital

    Toronto, Ontario, M5G 1X6

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
ELUVIA (Stent Implantation), Zilver PTX (Stent Implantation)
Keywords
atherosclerosis, Superficial Femoral Artery (SFA), Proximal Popliteal Artery (PPA), lower extremities, stenting, paclitaxel
Medical subject headings
Atherosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ELUVIA (Stent Implantation)Device

    Drug-eluting self-expanding stent implantation during the index procedure.

  • Zilver PTX (Stent Implantation)Device

    Drug-eluting self-expanding stent implantation during the index procedure.

Study groups in NCT02574481
Study groupRoleWhat they receive
ELUVIA Stent ImplantationExperimentalPercutaneous stent placement in the SFA/PPA
Receives: Device: ELUVIA (Stent Implantation)
Zilver PTX Stent ImplantationActive comparatorPercutaneous stent placement in the SFA/PPA
Receives: Device: Zilver PTX (Stent Implantation)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Major Adverse Events (MAEs)

    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

    Measured: 12 Months

  2. Number of Participants Reaching Primary Patency

    Primary patency of target lesion at 12-months assessed by duplex ultrasound and adjudicated by an independent core laboratory

    Measured: 12 Months

Secondary outcomes (6)

  1. Number of CEC-adjudicated Events Through 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.

    Measured: 12 Months

  2. Count of Participants Meeting Primary Sustained Clinical Improvement

    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.

    Measured: 12 Months

  3. Number of Participants With Hemodynamic Improvement

    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.

    Measured: 12 Months

  4. Walking Impairment Questionnaire (WIQ) Scores

    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.

    Measured: Baseline to 12 Months

  5. 6-Minute Walk Test - Distance Walked

    Change in distance walked from baseline to 12 months.

    Measured: Change in baseline to 12-Months

  6. 6-Minute Walk Test - Speed

    Change in speed walked from baseline to 12 months

    Measured: Baseline to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2015 (estimated)
  2. Study startDec 2015
  3. Primary completion28 Dec 2017
  4. Study completion12 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
524 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02574481
Sponsor's protocol ID
S2063
Acronym
IMPERIAL
Status last verified
Apr 2023
First submitted
22 Sep 2015
Last updated
8 May 2023
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: There is not a plan to make IPD available.

Publications

  • Iida O, Fujihara M, Kawasaki D, Mori S, Yokoi H, Miyamoto A, Kichikawa K, Nakamura M, Ohki T, Diaz-Cartelle J, Muller-Hulsbeck S, Gray WA, Soga Y. 24-Month Efficacy and Safety Results from Japanese Patients in the IMPERIAL Randomized Study of the Eluvia Drug-Eluting Stent and the Zilver PTX Drug-Coated Stent. Cardiovasc Intervent Radiol. 2021 Sep;44(9):1367-1374. doi: 10.1007/s00270-021-02901-6. Epub 2021 Jul 7.

    PubMed 34235560

  • Muller-Hulsbeck S, Benko A, Soga Y, Fujihara M, Iida O, Babaev A, O'Connor D, Zeller T, Dulas DD, Diaz-Cartelle J, Gray WA. Two-Year Efficacy and Safety Results from the IMPERIAL Randomized Study of the Eluvia Polymer-Coated Drug-Eluting Stent and the Zilver PTX Polymer-free Drug-Coated Stent. Cardiovasc Intervent Radiol. 2021 Mar;44(3):368-375. doi: 10.1007/s00270-020-02693-1. Epub 2020 Nov 22.

    PubMed 33225377

  • Golzar J, Soga Y, Babaev A, Iida O, Kawasaki D, Bachinsky W, Park J, Prem JT, Vermassen F, Diaz-Cartelle J, Muller-Hulsbeck S, Gray WA. Effectiveness and Safety of a Paclitaxel-Eluting Stent for Superficial Femoral Artery Lesions up to 190 mm: One-Year Outcomes of the Single-Arm IMPERIAL Long Lesion Substudy of the Eluvia Drug-Eluting Stent. J Endovasc Ther. 2020 Apr;27(2):296-303. doi: 10.1177/1526602820901723. Epub 2020 Jan 28.

    PubMed 31989856

  • Soga Y, Fujihara M, Iida O, Kawasaki D, Hirano K, Yokoi H, Miyamoto A, Kichikawa K, Nakamura M, Ohki T, Diaz-Cartelle J, Gray WA, Muller-Hulsbeck S. Japanese Patients Treated in the IMPERIAL Randomized Trial Comparing Eluvia and Zilver PTX Stents. Cardiovasc Intervent Radiol. 2020 Feb;43(2):215-222. doi: 10.1007/s00270-019-02355-x. Epub 2019 Nov 5.

    PubMed 31690980

  • Gray WA, Keirse K, Soga Y, Benko A, Babaev A, Yokoi Y, Schroeder H, Prem JT, Holden A, Popma J, Jaff MR, Diaz-Cartelle J, Muller-Hulsbeck S; IMPERIAL investigators. A polymer-coated, paclitaxel-eluting stent (Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX) for endovascular femoropopliteal intervention (IMPERIAL): a randomised, non-inferiority trial. Lancet. 2018 Oct 27;392(10157):1541-1551. doi: 10.1016/S0140-6736(18)32262-1. Epub 2018 Sep 24.

    PubMed 30262332

Questions about this trial

What is this clinical trial studying?

A study testing ELUVIA (Stent Implantation) and Zilver PTX (Stent Implantation) in people with Atherosclerosis of Native Arteries of the Extremities, run by Boston Scientific Corporation at 68 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 sites in United States, Japan, Germany, Austria, Belgium and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Major Adverse Events (MAEs) (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02574481, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in