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

NCT02574481 | Completed Results DMC FDA Device

• 1 other identifier: S2063
• Study Type: interventional
• Target: 524
• Locations: 7 countries
• Sites: 68

Brief 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. 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.

Conditions

Atherosclerosis of Native Arteries of the Extremities

Keywords

atherosclerosis; Superficial Femoral Artery (SFA); Proximal Popliteal Artery (PPA); lower extremities; stenting; paclitaxel

Outcome Measures

Primary Outcomes (2)

• 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

  12 Months

• 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

  12 Months

Secondary Outcomes (6)

• Number of CEC-adjudicated Events Through 12 Months

  12 Months

• Count of Participants Meeting Primary Sustained Clinical Improvement

  12 Months

• Number of Participants With Hemodynamic Improvement

  12 Months

• Walking Impairment Questionnaire (WIQ) Scores

  Baseline to 12 Months

• 6-Minute Walk Test - Distance Walked

  Change in baseline to 12-Months

Other Outcomes (3)

• Freedom From Major Adverse Events

  Through 60 Months

• Clinical Events Committee Adjudicated Clinically-Driven Target Lesion Revascularization Rate

  Through 60 Months

• Percentage of Participants With Target Limb Major Amputation

  Through 60 Months

Study Arms (2)

ELUVIA Stent Implantation

EXPERIMENTAL

Percutaneous stent placement in the SFA/PPA

Device: ELUVIA (Stent Implantation)

Zilver PTX Stent Implantation

ACTIVE COMPARATOR

Percutaneous stent placement in the SFA/PPA

Device: Zilver PTX (Stent Implantation)

Interventions

ELUVIA (Stent Implantation) DEVICE

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

ELUVIA Stent Implantation

Zilver PTX (Stent Implantation) DEVICE

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

Zilver PTX Stent Implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (68)

Yuma Regional Medical Center

Yuma, Arizona, 85364, United States

Location

University of California, Davis Medical Center

Sacramento, California, 95817, United States

Location

Florida Research Network, LLC

Gainesville, Florida, 32605, United States

Location

First Coast Cardiovascular Institute

Jacksonville, Florida, 32216, United States

Location

Baptist Cardiac and Vascular Institute

Miami, Florida, 33176, United States

Location

Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

MediQuest Research at Munroe Regional Medical Center

Ocala, Florida, 34471, United States

Location

Baptist Hospital

Pensacola, Florida, 32501, United States

Location

University Hospital

Augusta, Georgia, 30901, United States

Location

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453, United States

Location

St. Francis Medical Center

Peoria, Illinois, 61614, United States

Location

St. Joseph Hospital

Fort Wayne, Indiana, 46802, United States

Location

Maine Medical Center

Portland, Maine, 04102, United States

Location

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

Boston, Massachusetts, 02135, United States

Location

Northern Michigan Hospital

Petoskey, Michigan, 49770, United States

Location

Mercy Hospital

Coon Rapids, Minnesota, 55433, United States

Location

Mayo Clinic Foundation

Rochester, Minnesota, 55905, United States

Location

Alegent Creighton Health Bergan Mercy Medical Center

Omaha, Nebraska, 68124, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

New Mexico Heart Institute, PA

Albuquerque, New Mexico, 87102, United States

Location

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

New York University Medical Center

New York, New York, 10016, United States

Location

New York Presbyterian Hospital-Columbia University Medical Center

New York, New York, 10032, United States

Location

Carolinas HealthCare System NorthEast

Concord, North Carolina, 28025, United States

Location

Rex Hospital

Raleigh, North Carolina, 27607, United States

Location

Aultman Hospital

Canton, Ohio, 44710, United States

Location

University of Toledo Medical Center

Toledo, Ohio, 43614, United States

Location

LakeWest Hospital/Northeast Ohio Vascular Associates, Inc.

Willoughby, Ohio, 44094-4662, United States

Location

Providence St. Vincents Medical Center

Portland, Oregon, 97225, United States

Location

Lankenau Institute for Medical Research

Bryn Mawr, Pennsylvania, 19010, United States

Location

Albert Einstein Medical Center

Philadelphia, Pennsylvania, 19141, United States

Location

Pinnacle Health Cardiovascular Institute

Wormleysburg, Pennsylvania, 17043, United States

Location

York Hospital

York, Pennsylvania, 17405, United States

Location

Avera Heart Hospital of South Dakota

Sioux Falls, South Dakota, 57108, United States

Location

University Surgical Associates

Chattanooga, Tennessee, 37403, United States

Location

Jackson-Madison County General Hospital

Jackson, Tennessee, 38301, United States

Location

St. Thomas Research Institute, LLC

Nashville, Tennessee, 37205, United States

Location

Texas Health Presbyterian Hospital

Dallas, Texas, 75231, United States

Location

The Methodist Hospital Research Institute

Houston, Texas, 77030, United States

Location

The Heart Hospital Baylor Plano

Plano, Texas, 75093, United States

Location

Aspirus Heart and Vascular Institute - Research and Education

Wausau, Wisconsin, 54401, United States

Location

Medical University Graz, Department of Radiology

Graz, Austria

Location

Allgemeines Krankenhaus AKH

Vienna, Austria

Location

Hanusch Hospital

Vienna, Austria

Location

Ziekenhuis oost Limburg

Genk, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

Regionaal Ziekenhuis Heilig Hart Tienen

Tienen, 3300, Belgium

Location

Toronto General Hospital

Toronto, Ontario, M5G 1X6, Canada

Location

Fleurimont Hospital

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Universitäts-Herzzentrum Bad Krozingen

Bad Krozingen, Germany

Location

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

Berlin, Germany

Location

Vivantes Klinikum Neukölln

Berlin, Germany

Location

Ev. Luth. Diakonissenanstalt Flensburg

Flensburg, Germany

Location

Universität Leipzig

Leipzig, Germany

Location

Kokura Memorial Hospital

Kitakyushu, Fukuoka, Japan

Location

Kansai Rosai Hospital

Amagasaki, Hyōgo, Japan

Location

Takatsu General Hospital

Kawasaki, Kanagawa, Japan

Location

Saiseikai Yokohama-City Eastern Hospital

Yokohama, Kanagawa, Japan

Location

Nara Medical University Hospital

Kashihara-shi, Nara, Japan

Location

Kishiwada Tokushukai Hospital

Kishiwada, Osaka, Japan

Location

Toho University Ohashi Medical Center

Meguro City, Tokyo, Japan

Location

The Jikei University Hospital

Minato, Tokyo, Japan

Location

Fukuoka Sanno Hospital

Fukuoka, Japan

Location

Morinomiya Hospital

Osaka, Japan

Location

Auckland City Hospital

Auckland, New Zealand

Location

Middlemore Hospital

Auckland, New Zealand

Location

Clinical Trials NZ

Hamilton, New Zealand

Location

Related Publications (5)

• 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.

  PMID: 34235560 DERIVED

• 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.

  PMID: 33225377 DERIVED

• 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.

  PMID: 31989856 DERIVED

• 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.

  PMID: 31690980 DERIVED

• 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.

  PMID: 30262332 DERIVED

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Nicole Kilburn
• Organization: Boston Scientific

Nicole.Kilburn@bsci.com

970-294-4082

Study Officials

• William Gray, MD

  Main Line Health

  PRINCIPAL INVESTIGATOR

• Stefan Müller-Hülsbeck, Prof

  Ev. Luth. Diakonissenanstalt Flensburg

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2015
• First Posted: October 14, 2015
• Study Start: December 1, 2015
• Primary Completion: December 28, 2017
• Study Completion: April 12, 2022
• Last Updated: May 8, 2023
• Results First Posted: January 7, 2019

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2); BE (3); NZ (3); JP (10); US (42); AU (3); DE (5)