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

NCT ID: NCT02574481

Last Updated: 2023-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 524 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2022-04-12

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.

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.

Conditions

Atherosclerosis of Native Arteries of the Extremities

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ELUVIA Stent Implantation

Percutaneous stent placement in the SFA/PPA

Group Type: EXPERIMENTAL

ELUVIA (Stent Implantation)

Intervention Type: DEVICE

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

Zilver PTX Stent Implantation

Percutaneous stent placement in the SFA/PPA

Group Type: ACTIVE_COMPARATOR

Zilver PTX (Stent Implantation)

Intervention Type: DEVICE

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

Interventions

ELUVIA (Stent Implantation)

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

Intervention Type: DEVICE

Zilver PTX (Stent Implantation)

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William Gray, MD

Role: PRINCIPAL_INVESTIGATOR

Main Line Health

Stefan Müller-Hülsbeck, Prof

Role: PRINCIPAL_INVESTIGATOR

Ev. Luth. Diakonissenanstalt Flensburg

Locations

Yuma Regional Medical Center

Yuma, Arizona, United States

University of California, Davis Medical Center

Sacramento, California, United States

Florida Research Network, LLC

Gainesville, Florida, United States

First Coast Cardiovascular Institute

Jacksonville, Florida, United States

Baptist Cardiac and Vascular Institute

Miami, Florida, United States

Mount Sinai Medical Center

Miami Beach, Florida, United States

MediQuest Research at Munroe Regional Medical Center

Ocala, Florida, United States

Baptist Hospital

Pensacola, Florida, United States

University Hospital

Augusta, Georgia, United States

Advocate Christ Medical Center

Oak Lawn, Illinois, United States

St. Francis Medical Center

Peoria, Illinois, United States

St. Joseph Hospital

Fort Wayne, Indiana, United States

Maine Medical Center

Portland, Maine, United States

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

Boston, Massachusetts, United States

Northern Michigan Hospital

Petoskey, Michigan, United States

Mercy Hospital

Coon Rapids, Minnesota, United States

Mayo Clinic Foundation

Rochester, Minnesota, United States

Alegent Creighton Health Bergan Mercy Medical Center

Omaha, Nebraska, United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

New Mexico Heart Institute, PA

Albuquerque, New Mexico, United States

Maimonides Medical Center

Brooklyn, New York, United States

New York University Medical Center

New York, New York, United States

New York Presbyterian Hospital-Columbia University Medical Center

New York, New York, United States

Carolinas HealthCare System NorthEast

Concord, North Carolina, United States

Rex Hospital

Raleigh, North Carolina, United States

Aultman Hospital

Canton, Ohio, United States

University of Toledo Medical Center

Toledo, Ohio, United States

LakeWest Hospital/Northeast Ohio Vascular Associates, Inc.

Willoughby, Ohio, United States

Providence St. Vincents Medical Center

Portland, Oregon, United States

Lankenau Institute for Medical Research

Bryn Mawr, Pennsylvania, United States

Albert Einstein Medical Center

Philadelphia, Pennsylvania, United States

Pinnacle Health Cardiovascular Institute

Wormleysburg, Pennsylvania, United States

York Hospital

York, Pennsylvania, United States

Avera Heart Hospital of South Dakota

Sioux Falls, South Dakota, United States

University Surgical Associates

Chattanooga, Tennessee, United States

Jackson-Madison County General Hospital

Jackson, Tennessee, United States

St. Thomas Research Institute, LLC

Nashville, Tennessee, United States

Texas Health Presbyterian Hospital

Dallas, Texas, United States

The Methodist Hospital Research Institute

Houston, Texas, United States

The Heart Hospital Baylor Plano

Plano, Texas, United States

Aspirus Heart and Vascular Institute - Research and Education

Wausau, Wisconsin, United States

Medical University Graz, Department of Radiology

Graz, , Austria

Allgemeines Krankenhaus AKH

Vienna, , Austria

Hanusch Hospital

Vienna, , Austria

Ziekenhuis oost Limburg

Genk, , Belgium

Universitair Ziekenhuis Gent

Ghent, , Belgium

Regionaal Ziekenhuis Heilig Hart Tienen

Tienen, , Belgium

Toronto General Hospital

Toronto, Ontario, Canada

Fleurimont Hospital

Sherbrooke, Quebec, Canada

Universitäts-Herzzentrum Bad Krozingen

Bad Krozingen, , Germany

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

Berlin, , Germany

Vivantes Klinikum Neukölln

Berlin, , Germany

Ev. Luth. Diakonissenanstalt Flensburg

Flensburg, , Germany

Universität Leipzig

Leipzig, , Germany

Kokura Memorial Hospital

Kitakyushu, Fukuoka, Japan

Kansai Rosai Hospital

Amagasaki, Hyōgo, Japan

Takatsu General Hospital

Kawasaki, Kanagawa, Japan

Saiseikai Yokohama-City Eastern Hospital

Yokohama, Kanagawa, Japan

Nara Medical University Hospital

Kashihara-shi, Nara, Japan

Kishiwada Tokushukai Hospital

Kishiwada, Osaka, Japan

Toho University Ohashi Medical Center

Meguro City, Tokyo, Japan

The Jikei University Hospital

Minato, Tokyo, Japan

Fukuoka Sanno Hospital

Fukuoka, , Japan

Morinomiya Hospital

Osaka, , Japan

Auckland City Hospital

Auckland, , New Zealand

Middlemore Hospital

Auckland, , New Zealand

Clinical Trials NZ

Hamilton, , New Zealand

Countries

United States; Austria; Belgium; Canada; Germany; Japan; New Zealand

References

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.

Reference Type: DERIVED

PMID: 34235560 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33225377 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31989856 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31690980 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30262332 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

S2063

Identifier Type: -

Identifier Source: org_study_id